Beta‐glucans from oats or barley and reduction of postprandial glycaemic responses: Modification of an authorised health claim pursuant to Article 13(1) of Regulation (EC) No 1924/2006 following a request in accordance with Article 19 of Regulation (EC) No 1924/2006

Abstract

Following an application from PepsiCo International, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the modification of an authorised health claim related to beta‐glucans from oats or barley and reduction of postprandial glycaemic responses. The proposed modification concerns a reduction of the lowest effective dose from 4 g to 2 g of beta‐glucans (BG) per 30 g of available carbohydrates (avCHO). Beta‐glucans from oat and barley, which are the subject of the health claim, have been sufficiently characterised. A reduction of postprandial glycaemic responses is a beneficial physiological effect in the context of the food/constituent and the target population for this claim. The applicant submitted 21 pertinent published human intervention studies (59 trial comparisons) investigating the effect of beta‐glucans from oat or barley on the postprandial incremental area under the curve (iAUC) for glucose using matched comparators and conducted a dose–response meta‐regression analysis. Four published systematic reviews and dose–response meta‐regression analyses were also provided. In weighing the evidence, the Panel considered that the human intervention studies did not consistently show a significant effect of beta‐glucans from oats or barley on postprandial glucose iAUC at doses between 2 and < 4 g BG/30 g avCHO, and that dose–response data suggest a lowest effective dose above the 2 g/30 g avCHO proposed by the applicant. The Panel concludes that a consistent effect of beta‐glucans from oats or barley on the reduction of postprandial glycaemic responses has not been demonstrated under the conditions of use proposed by the applicant of at least 2 g BG/30 g avCHO consumed with a meal.

1. INTRODUCTION

1.1. Background and Terms of Reference as provided by the requestor

Regulation (EC) No 1924/2006 ¹ harmonises the provisions that relate to nutrition and health claims and establishes rules governing the Community authorisation of health claims made on foods. As a rule, health claims are prohibited unless they comply with the general and specific requirements of this Regulation, are authorised in accordance with this Regulation, and are included in the lists of authorised claims provided for in Articles 13 and 14 thereof.

The same Regulation, as referred to in Article 19, also lays down provisions for the modification, suspension and revocation of authorisations. The procedures laid down in Articles 15 and 18 shall apply mutatis mutandis.

1.2. Interpretation of the Terms of Reference

EFSA is requested to evaluate the scientific data submitted by the applicant in accordance with Article 19 of Regulation (EC) No 1924/2006. On the basis of that evaluation, EFSA will issue an opinion on the scientific substantiation of an application to modify the conditions of use of an authorised Article 13(1) claim related to: beta‐glucans from oats or barley and reduction of postprandial glycaemic responses.

On the basis of that evaluation, EFSA will issue an opinion on the scientific substantiation of a health claim related to beta‐glucans from oats or barley and reduction of postprandial glycaemic responses under the new conditions of use proposed by the applicant.

The present opinion does not constitute, and cannot be construed as, an authorisation for the marketing of beta‐glucans from oats or barley, a positive assessment of its safety, nor a decision on whether beta‐glucans from oats or barley, is, or is not, classified as a foodstuff. It should be noted that such an assessment is not foreseen in the framework of Regulation (EC) No 1924/2006.

It should also be highlighted that the scope, the proposed wording of the claim and the conditions of use as proposed by the applicant may be subject to changes, pending the outcome of the authorisation procedure foreseen in Article 18(4) of Regulation (EC) No 1924/2006.

2. DATA AND METHODOLOGIES

2.1. Data

Information provided by the applicant

See also the section ‘Steps taken by EFSA’ at the end of this opinion.

Food/constituent as stated by the applicant

According to the applicant, the food for which the health claim is made is ‘beta‐glucans from oat or barley’. The application applies to oat and barley beta‐glucans naturally present in foods, and to beta‐glucans isolated from oat or barley, both in foods and beverages.

Health relationship as claimed by the applicant

According to the applicant, the specific body function that is the subject of the claimed effect is the ‘reduction of post‐prandial glycaemic responses’.

Mechanism by which the food/constituent could exert the claimed effect as proposed by the applicant

The applicant suggests that the effect derives from the ability of beta‐glucans to form viscous solutions in the gastrointestinal tract and may downregulate the expression of the glucose transporters sodium‐glucose cotransporter type (SGLT) 1 and glucose transporter type (GLUT) 2 in intestinal epithelial cells, which was accompanied by decreased glucose uptake, as shown in rats.

Wording of the health claim as proposed by the applicant

The applicant has proposed the following wording for the health claim: ‘consumption of 2 g beta‐glucans from oats or barley/30 g available carbohydrates as part of a meal contributes to the reduction of the glucose rise after that meal’.

Specific conditions of use as proposed by the applicant

According to the applicant, ‘in order to obtain the claimed effect, at least 2 g of beta‐glucans from oats or barley for each 30 g of available carbohydrates should be consumed per meal. The target population is individuals who wish to reduce their postprandial glycaemic responses’.

Data provided by the applicant

The health claim application on the modification of the authorisation of a health claim related to beta‐glucans from oats or barley and reduction of postprandial glycaemic responses pursuant to Article 13(3) of Regulation (EC) No 1924/2006 in accordance with Article 19 of Regulation (EC) No 1924/2006 was presented in a common and structured format as outlined in the Scientific and technical guidance for the preparation and presentation of a health claim application (EFSA NDA Panel, 2021c).

As outlined in the General scientific guidance for stakeholders on health claim applications (EFSA NDA Panel, 2021b), it is the responsibility of the applicant to provide the totality of the available evidence.

The application does not contain data claimed as confidential or proprietary by the applicant.

2.2. Methodologies

The approach used by the NDA Panel for the evaluation of health claims is explained in the General scientific guidance for stakeholders on health claim applications (EFSA NDA Panel, 2021b). In assessing each specific food‐health relationship, which forms the basis of a health claim, the NDA Panel considers the following key criteria:

1. the food/constituent is defined and characterised;

2. the claimed effect is based on the essentiality of a nutrient; OR the claimed effect is defined and is a beneficial physiological effect for the target population and can be measured in vivo in humans;

3. a cause‐and‐effect relationship is established between the consumption of the food/constituent and the claimed effect (for the target group under the proposed conditions of use).

Each of these three criteria needs to be assessed by the NDA Panel with a favourable outcome for a claim to be substantiated. In addition, an unfavourable outcome of the assessment of criterion (i) and/or (ii) precludes the scientific assessment of criterion (iii).

The scientific requirements for health claims related to blood glucose concentrations, are outlined in a specific EFSA Guidance on the scientific requirements for health claims related to appetite ratings, weight management and blood glucose concentrations (EFSA NDA Panel, 2012).

2.3. Public consultation

According to Art. 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a Public Consultation on the non‐confidential version of the application from 21 February 2025 to 14 March 2024 (PC‐1330). The outcome of the public consultation is described in Appendix A to this Scientific Opinion.

3. ASSESSMENT

The Panel has already adopted an opinion on the scientific substantiation of a health claim related to beta‐glucans and reduction of postprandial glycaemic responses with a favourable outcome pursuant to Article 13(1) of Regulation (EC) No 1924/2006 (EFSA NDA Panel, 2011). On 16 May 2012, the European Commission adopted Regulation (EU) No 432/2012, which authorised a health claim related to ‘Consumption of beta‐glucans from oats or barley as part of a meal contributes to the reduction of the blood glucose rise after that meal’. The authorised conditions of use for the claim are: ‘The claim may be used only for food which contains at least 4 g of beta‐glucans from oats or barley for each 30 g of available carbohydrates in a quantified portion as part of the meal. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained by consuming the beta‐glucans from oats or barley as part of the meal’.

With the present application, the applicant has requested the following modification of the conditions of use: ‘at least 2 g beta‐glucans from oats or barley/30 g available carbohydrates as part of a meal should be consumed in order to obtain the claimed effect’.

Thus, the present opinion will address whether a cause‐and‐effect relationship between the consumption of beta‐glucans from oats or barley and a reduction of postprandial glycaemic responses, which was established under the conditions of use for the authorised claim, can also be established under the new conditions of use proposed by the applicant.

3.1. Characterisation of the food/constituent

The food proposed by the applicant as the subject of the health claim is beta‐glucans from oats or barley.

The Panel notes that beta‐glucans from oat and barley, which are the subject of the health claim, have been sufficiently characterised in relation to the claimed effect (EFSA NDA Panel, 2011).

3.2. Relevance of the claimed effect to human health

The claimed effect is the ‘reduction of postprandial glycaemic response’. The proposed target population is ‘individuals who wish to reduce their postprandial glycaemic responses’.

Claims on the reduction of postprandial blood glucose responses refer to the ability of a food/constituent to reduce the blood glucose rise after consumption of a food or meal rich in digestible carbohydrates (i.e. in comparison to a reference food or meal).

The scientific evidence for the substantiation of health claims on the reduction of postprandial blood glucose responses can be obtained from human intervention studies showing a decrease in blood glucose concentrations at different time points after consumption of the test food during an appropriate period of time (i.e. at least 2 h) and no increase in insulin concentrations in comparison to the reference food (EFSA NDA Panel, 2012).

Consistent with this guidance, the applicant proposed the incremental area under the curve (iAUC) for glucose (and insulin) in blood as the relevant endpoint to assess the claimed effect in vivo in humans. The peak blood glucose raise was proposed as a secondary endpoint.

The applicant claims that the postprandial glycaemic peak has been shown to be an independent risk factor for cardiovascular diseases (CVD) and provides three references to support this statement. One publication reports on a cross‐sectional study with a standard meal challenge protocol in individuals with normal vs. impaired glucose tolerance. Fasting and postprandial levels of glucose, insulin, blood lipids, high sensitivity C‐reactive protein (hs‐CRP), plasminogen activator inhibitor‐1 (PAI‐1), adiponectin and endothelial function were assessed (Crandall et al., 2009). The second publication reports cross‐sectional data on the relationship between 2‐h postprandial glucose (and not postprandial peak glucose) after an oral glucose tolerance test (OGTT) and the carotid artery intima‐media thickness (IMT) in non‐diabetic individuals (Hanefeld et al., 1999). The third publication is a cross‐sectional study that addresses the relationship between several measures of plasma glucose (PG), such as fasting PG (FPG), post‐challenge PG at 30, 60, 90 and 120 min after an OGTT, maximal PG during an OGTT, post‐challenge glucose spikes (PGS) defined as the difference between maximal PG during an OGTT and FPG, the iAUC during the OGTT and HbA_1c, and the carotid artery IMT in individuals with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) or type 2 diabetes (Temelkova‐Kurktschiev et al., 2000). The Panel notes that none of these studies, by design, can provide sufficient evidence for an independent effect of the above‐mentioned postprandial PG variables in isolation on CVD risk. The Panel also notes that, in the last study (Temelkova‐Kurktschiev et al., 2000), all PG parameters during the OGTT, except for the 30‐min glucose, were significantly correlated with the IMT and strongly related with each other.

The Panel notes that the iAUC for glucose measured at standard time intervals during 2‐h in healthy individuals after a test meal, which is used to calculate the glycaemic index (GI) of foods as compared to a reference (e.g. glucose, white bread), provides a good summary of postprandial glycaemia and predicts peak (or near peak) response, the maximum glucose fluctuation and other attributes of the glucose response curve (Brand‐Miller et al., 2009). The Panel also notes that nutrition recommendations for carbohydrate‐containing foods for diabetes, pre‐diabetes and cardiovascular diseases in Europe emphasise the GI of foods, in addition to the dietary fibre content, as a criterium for food selection (Rydén et al., 2013).

In agreement with the applicant, the Panel considers that the iAUC for glucose (and insulin) measured at standard time intervals for 2‐h after consumption of the test (and control) foods is the appropriate endpoint for the scientific substantiation of health claims on the reduction of postprandial blood glucose responses made on food. The Panel also considers that other PG measurements after consumption of the test (and control) foods under controlled conditions, such as e.g. the maximal PG, the incremental peak glucose (iPkG) defined as the difference between maximal PG and FPG, or PG at 120 min, can be used as supportive evidence for the scientific substantiation of these claims.

The Panel notes that the reduction of postprandial glycaemic responses may be a beneficial physiological effect (e.g. for individuals with IGT), as long as postprandial insulinemic responses are not disproportionally increased (EFSA NDA Panel, 2012).

The Panel considers that the reduction of postprandial glycaemic responses is a beneficial physiological effect in the context of the food/constituent and the target population for this claim.

3.3. Scientific substantiation of the claimed effect

The applicant performed a literature search in the databases PubMed and Cochrane Library with no time or language restriction to retrieve human intervention studies using keywords in relation to the food constituent (oat, barley, beta‐glucan, b‐glucan) and keywords related to the claimed effect (post‐prandial, postprandial, glucose, glycemi*, glycaemi*). The full search strategy with keywords, the PICO questions (Population, Intervention, Comparators, Outcomes) and eligibility criteria were provided by the applicant.

Inclusion criteria were single‐meal, randomised controlled trials (RCTs) with a crossover design investigating the effect of oat and/or barley beta‐glucans from a variety of sources after an overnight fast on postprandial glucose and insulin responses reported as iAUC. Incremental peak glucose rise was also considered as a secondary endpoint. Only studies testing beta‐glucan doses < 4 g/30 g available carbohydrates (avCHO) were included. Test and reference foods had to be sufficiently characterised and comparable with regards to factors other than the amount of oats or barley beta‐glucans that could impact the endpoints of interest. To this end, only studies or study comparisons with a difference within 1 g in the amount of avCHO tested were eligible.

The applicant acknowledged that, in addition to having nearly equivalent avCHO, the least biased comparator for showing the independent effect of beta‐glucan is comparing the same food/drink with beta‐glucan with one that contains no beta‐glucan, as it takes into account food processing, food form, cooking method and other nutrients that could impact the endpoints of interest. However, several studies compared the test food to glucose as the only comparator or as a second comparator. These studies or study comparisons were included and analysed separately.

Upon EFSA's request for clarification in which it was noted that the glucose comparator (reference) is not relevant to the claim when solid foods are tested, as virtually all solid foods inherently induce lower postprandial glycaemic responses than a glucose solution, the applicant explained that this comparison was not considered inappropriate by EFSA in other opinions (EFSA NDA Panel, 2011, 2021a), and that the glucose comparison can provide valuable insights about the postprandial blood glucose‐lowering effect of beta‐glucans in different contexts. The Panel wishes to clarify that the main evidence considered for the scientific substantiation of the health claim on beta‐glucans from oats and barley (EFSA NDA Panel, 2011), and for establishing conditions of use for the claim, did not come from the comparison between beta‐glucan containing solid foods and glucose. Furthermore, the effect of beta‐glucans in ready‐to‐eat cereals, as compared to glucose, was not demonstrated to be specific to beta‐glucans, a main argument for the negative opinion (EFSA NDA Panel, 2021a). In addition, the Panel reiterates the considerations expressed in a reply to the comments received regarding a previous opinion on a health claim related to high‐fibre sourdough rye bread and reduction of postprandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006 (EFSA NDA Panel, 2015), namely that:

1. Considering generally accepted scientific evidence, when comparable amounts of available carbohydrates from different carbohydrate‐containing foods are tested, almost any carbohydrate‐containing food (see also Atkinson et al. (2008)) would induce a reduction of postprandial blood glucose responses compared with the blood glucose responses elicited by the consumption of glucose; and.

2. Specificity is one of the essential aspects considered by the Panel in the scientific assessment of a cause‐and‐effect relationship between the consumption of a food/constituent and the claimed effect (EFSA NDA Panel, 2021b), which is in line with Regulation (EU) No 1169/2011 on the provision of food information to consumers, and in particular Article 7.1. Food information shall not be misleading, particularly by: (c) suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics, in particular by specifically emphasising the presence or absence of certain ingredients and/or nutrients.

In that context, the Panel considers that, although the glucose comparator is appropriate to calculate the GI of foods, including solid foods containing beta‐glucans, as noted by the applicant, such comparison does not provide information about the effect of beta‐glucans from oats and barley on the postprandial glycaemic responses to solid foods or about the amount of beta‐glucans per a given amount of avCHO that would be needed to achieve the claimed effect. Therefore, the Panel considers that no conclusions can be drawn from these comparisons for the requested modification of the conditions of use (CoU) for the authorised claim and will not be discussed further in this opinion. The Panel considers, however, that glucose solutions are an appropriate comparator to assess the effect of beta‐glucans when added to beverages of otherwise similar composition.

Exclusion criteria were studies in individuals with diabetes, or assessing the long‐term effects of beta‐glucans, or using beta‐glucans from sources other than oats and barley, or studies in which the amount of beta‐glucans and/or avCHO tested was not specified, and studies or study comparisons investigating beta‐glucans that were artificially degraded (e.g. by enzymatic hydrolysis) to lower molecular weight (MW) and/or viscosity, as this process lowers the ‘post‐prandial glucose‐lowering efficacy (Wood et al., 1994)’.

In relation to the last exclusion criteria, EFSA noted that, in the comparisons excluded by the applicant because beta‐glucans were ‘enzymatically degraded’ or of ‘low viscosity’, the MW of beta‐glucans were within the range provided in the characterisation of the food constituent (50–2000 kDa) and were comparable to the MW of beta‐glucans of other comparisons included in the application. The applicant was requested to justify such exclusions, as beta‐glucans were not defined by the manufacturing process or in terms of viscosity in the authorised claim. In reply, the applicant agreed to include these studies or study comparisons in the assessment, acknowledging the characterisation of the food/constituent in the authorised claim.

3.3.1. Human intervention studies

3.3.1.1. Individual studies

From the literature search, the applicant identified 25 published human intervention studies investigating the effect of beta‐glucans from oat or barley on the postprandial glycaemic response, with at least one test and one control food meeting the inclusion criteria specified above. Test and reference foods had to be sufficiently characterised and comparable with regards to factors other than the amount of oats and barley beta‐glucans that could impact the endpoints of interest.

One study (Yokoyama et al., 1997) was excluded by the applicant upon EFSA's request for clarification, as it was not a randomised controlled trial and thus did not meet the inclusion criteria. Another study (Alminger & Eklund‐Jonsson, 2008) compared solid foods containing beta‐glucans (barley and oat tempeh) to a glucose reference only, and not to relevant control foods with different amounts of beta‐glucans. As explained above, the Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.

In one study (Lindström et al., 2015), 250 g of a milk‐based oat drink with or without lactic acid bacteria and a yogurt consumed together with white bread were tested against white bread +250 g of water (control). All meals were standardised to contain 50 g avCHO. The applicant indicated that the appropriate comparison was the oat drink without the lactic acid bacteria vs. the yogurt meal. Upon EFSA's request for clarification on how the different macronutrient composition of the test and ‘control’ meals could impact the postprandial blood glucose responses, the applicant replied that a mistake was made in the original application and that the correct comparison would be the milk‐based oat drink versus the white bread control, arguing that the large difference in protein and fat content between the test and control foods per se would have a minor impact on the glycaemic responses. EFSA notes that milk proteins induce quick and high insulin responses upon consumption (Nilsson et al., 2004) and that this effect could induce low postprandial glycaemic responses in the test vs. the control food independently of the beta‐glucan content. Indeed, larger iAUC for insulin were found at 0–15 min for the milk‐based oat drink and yogurt meals as compared to the white bread control (Lindström et al., 2015). The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.

Out of the remaining 22 human intervention studies, 21 were conducted as single‐meal challenges and used a randomised crossover design with washout periods ranging from 1 day to 2 weeks, while 7 studies did not explicitly report the duration of the washout period. The study populations primarily consisted of healthy adults of both sexes, though one study (Hartvigsen et al., 2014) investigated participants with metabolic syndrome. Participant numbers across the studies ranged from 8 to 40. A wide array of food matrices was tested, including various cereal‐based products such as breads, pasta, crackers, cookies, muesli, oatmeal, chapati, granola and cooked oats/rice combinations. Five studies specifically explored the effect of beta‐glucans in beverages: oat drinks (Kwong et al., 2013a; Kwong et al., 2013b), fruit juice with beta‐glucan concentrate (Paquin et al., 2013) and glucose drinks containing beta‐glucan extracts (Panahi et al., 2007). While most studies provided approximately 50 g of avCHO in the test and control meals, some studies used lower (e.g. around 26–28 g in Rieder et al. (2019) and Wolever et al. (2018), around 30–40 g in Wolever et al. (2019), Östman et al. (2006), Paquin et al. (2013) and Casiraghi et al. (2006)) or higher (e.g. 75 g in Panahi et al. (2007)) amounts of avCHO, or both. Regand et al. (2009) used meals ranging from 42 to 65 g avCHO. A standardised evening meal prior to each test day was reported in only five of the 21 studies (Ekström et al., 2017; Finocchiaro et al., 2012; Granfeldt et al., 2008; Hartvigsen et al., 2014; Holm et al., 1992). Five studies were designed as dose–response investigations, assessing the effect of multiple beta‐glucan doses on the postprandial glycaemic response (Cavallero et al., 2002; Chillo et al., 2011; Thondre & Henry, 2009; Wolever et al., 2018; Zhu et al., 2020). All studies assessed the postprandial iAUC for glucose over 120 min, while 12 studies also reported on the iPkG, defined as the difference between the maximal postprandial PG and FPG. Seven studies also assessed postprandial insulin iAUC, with no significant increases observed in any of the studies. This endpoint will not be discussed further in the opinion, as it is known that dietary fibre in general, and oats and barley beta‐glucans in particular, do not disproportionally increase postprandial insulin responses when consumed with available carbohydrate‐containing foods (EFSA NDA Panel, 2011).

In the remaining study (Poppitt et al., 2007), the test meal contained 145 g avCHO and the postprandial glucose iAUC was assessed over 360 min. While this study could be considered as supportive evidence for the scientific substantiation of the claim (i.e. to substantiate the effect of beta‐glucans on postprandial glucose responses), the Panel excluded it for establishing conditions of use, i.e. to assess the consistency of the effect across different beta‐glucan dose ranges. This is because the testing conditions differed substantially from the other 21 studies included in the body of evidence, which typically used test meals with ≤ 75 g avCHO and measured glucose iAUC over 120 min. The extended measurement period and the high amount of available carbohydrates in the test meal made the results not comparable and less representative of normal eating conditions.

Details on the characteristics of the 21 studies included (59 trial comparisons) and the results for the postprandial glucose iAUC and iPkG can be found in Table B.1, Appendix B. For one study (Chillo et al., 2011), the doses of beta‐glucan in the test foods were calculated considering the actual amount of avCHO tested, rather than those planned at protocol level. The Panel notes that, in another study (Granfeldt et al., 2008), the dose of beta‐glucans tested was 2.4 g/30 g avCHO as reported in the original application, rather than 1.8 g/30 g avCHO as reported in the tables submitted by the applicant following ADRs.

The results of the 21 human intervention studies that are pertinent for the scientific substantiation of the claim under the proposed conditions of use will be discussed below according to the following ranges of beta‐glucan dose per 30 g avCHO in the test foods for each trial comparison (i.e. a comparison between the test food and its control): < 1 g, 1 to < 2 g, 2 to < 3 g, 3 to < 4 g. Studies investigating two or more beta‐glucan doses falling within different dose ranges will be addressed in different sections by trial comparison, and those investigating dose–response relationships (i.e. using three different doses of beta‐glucans per 30 g avCHO or more) will also be discussed separately at the end.

Trial comparisons testing < 1 g of beta‐glucans per 30 g of available carbohydrates

Four human intervention studies with six comparisons (Chillo et al., 2011; Paquin et al., 2013; Zhu et al., 2020) assessed the effects of beta‐glucans from oat and/or barley at doses < 1 g/30 g avCHO on postprandial glucose responses. Table 1 provides a summary of the test and control foods used in these studies, the beta‐glucan doses tested and the results regarding the postprandial iAUC for glucose and in the iPkG (when assessed).

TABLE 1.

Summary of trial comparisons testing foods with beta‐glucan (BG) doses < 1 g/30 g avCHO and postprandial glucose responses. ^a

Reference	Test food	Control food	BG dose g/30 g avCHO	Mean % iAUC (120 min) difference versus control	Mean % iPkG difference versus control
Pasta products
Chillo et al. (2011)	Semolina pasta + BG barley concentrates (Glucagel®)	Wheat pasta (semolina)	0.89	ns	NR
	Semolina pasta + BG barley concentrates (Barley balance®)		0.91	ns	NR
Bread products
Rieder et al. (2019)	Barley bread	Wheat bread	0.92	ns	ns
Cereal preparations
Zhu et al. (2020)	Pearled oats cooked under normal pressure + cooked rice	Cooked rice	0.96	ns	ns
	Pearled oats cooked under high pressure + cooked rice		0.96	ns	ns
Beverages
Paquin et al. (2013)	Oat BG concentrate + fruit juice	Fruit juice	0.98	ns	−22.7

Note: Different colours are used to differentiate between significant and non‐significant results.

Abbreviations: avCHO, available carbohydrates; BG, beta‐glucan; iAUC, incremental area under the curve; iPkG, incremental peak glucose; NR, not reported; ns, non‐statistically significant.

^a Trial comparisons sorted by type of food and beta‐glucan dose.

None of these trial comparisons testing < 1 g beta‐glucans per 30 g avCHO reported a significant difference in postprandial glucose iAUC between the test products (pasta, pearled oat and fruit juice) and their respective controls. A significant reduction in the iPkG (−22.7%) was observed only in the study with oat concentrate added to fruit juice (Paquin et al., 2013). However, this finding was not observed for the two oat/rice combinations (Chillo et al., 2011) or barley bread (Rieder et al., 2019) and the results for this endpoint were not reported in (Chillo et al., 2011).

The Panel notes that no effect on postprandial glucose iAUC was reported in the six comparisons, which tested beta‐glucans within the < 1 g/30 g avCHO dose range. Regarding iPkG, a significant reduction was observed in one of the four comparisons where this endpoint was reported.

Trial comparisons testing ≥ 1 g to < 2 g of beta‐glucans per 30 g of available carbohydrates

Eleven studies, encompassing 19 distinct comparisons, investigated the effect of beta‐glucan doses between 1 g and < 2 g per 30 g avCHO on postprandial glucose responses. Table 2 provides a summary of the test and control foods used in these studies, the beta‐glucan doses tested and the results regarding the postprandial glucose iAUC and the iPkG (when assessed).

TABLE 2.

Summary of trial comparisons testing foods with beta‐glucan doses between 1 and < 2 g/30 g avCHO and postprandial glucose responses. ^a

Reference	Test food	Control food	BG dose g/30 g avCHO	Mean % iAUC (120 min) difference vs control	Mean % iPkG difference versus control
Bread‐type products
Östman et al. (2006)	50% common barley bread	Wheat bread	1.07	ns	NR
Cavallero et al. (2002)	Barley flour bread	Wheat bread	1.19	ns	ns
Thondre and Henry (2009)	Wheat chapati + BG barley concentrates (Barley balance®)	Wheat chapati	1.2	ns	NR
Regand et al. (2009)	Oat crisp bread	Wheat crisp bread	1.88	ns	ns
Ekström et al. (2017)	Oat bread	Wheat bread	1.92	−37.5	−34.9
Rieder et al. (2019)	Oat‐concentrate bread	Wheat bread	1.93	−37.0	ns
Pasta products
Chillo et al. (2011)	Semolina pasta + BG barley concentrates (Glucagel®)	Durum semolina pasta	1.73	ns	NR
	Semolina pasta + BG barley concentrates (Barley balance®)		1.81	ns	NR
Cereal preparations
Zhu et al. (2020)	Whole grain oats cooked under normal pressure + cooked rice	Cooked rice	1.14	ns	ns
	Whole grain oats cooked under higher pressure + cooked rice		1.14	ns	ns
Wolever et al. (2020)	Instant oatmeal + oat bran BG	Cream of rice	1.17	ns	−21.3
Wolever et al. (2018)	Instant oatmeal + oat bran BG + 2% milk (240 mL)	Cream of rice	1.27	ns	−10.7
	Instant oatmeal + oat bran BG + 2% milk (240 mL)		1.48	ns	−12.7
Wolever et al. (2019)	Old‐fashioned oats + lactose‐ and fat‐free milk (218.5 g)	Cream of rice	1.69	ns	−16.1
Wolever et al. (2018)	Instant oatmeal + oat bran BG + 2% milk (240 mL)	Cream of rice	1.7	ns	−18
Wolever et al. (2019)	Steel cut oats + lactose‐ and fat‐free milk (218.5 g)	Cream of rice	1.71	−30.6	−26.1
	Instant oats + lactose‐ and fat‐free milk (218.5 g)		1.75	ns	ns
Zhu et al. (2020)	Pearled oats cooked under normal pressure	Cooked rice	1.86	−38.4	−37.1
	Pearled oats cooked under high pressure		1.86	−31.9	−37.1

Note: Different colours are used to differentiate between significant and non‐significant results.

Abbreviations: avCHO, available carbohydrates; BG, beta‐glucan; iAUC, incremental area under the curve; iPkG, incremental peak glucose; NR, not reported; ns, non‐statistically significant.

^a Trial comparisons sorted by type of food and beta‐glucan dose.

Among the studies employing bread‐type products, six comparisons from six studies were available. For postprandial glucose iAUC, a significant reduction was reported for an oat bread containing 1.92 g BG/30 g avCHO (−37.5%; Ekström et al. (2017)) and for a barley bread with oat bran concentrate containing 1.93 g BG/30 g avCHO (−37.0%; Rieder et al. (2019)). No significant effect on glucose iAUC was observed in the other four comparisons, which tested various barley breads, an oat crisp bread or an enriched chapati, with beta‐glucan doses ranging from 1.07 to 1.88 g per 30 g avCHO (Cavallero et al., 2002; Östman et al., 2006; Regand et al., 2009; Thondre & Henry, 2009). For iPkG, a significant reduction was reported only with the oat bread containing 1.92 g BG/30 g avCHO (−34.9%; Ekström et al. (2017)). No significant effect on iPkG was found in three other comparisons (Cavallero et al., 2002; Regand et al., 2009; Rieder et al., 2019), and this endpoint was not reported for the remaining two comparisons (Östman et al., 2006; Thondre & Henry, 2009).

For pasta products, one study (Chillo et al., 2011) assessed durum semolina spaghetti enriched with two distinct barley beta‐glucan concentrates containing 1.73 or 1.81 g BG/30 g avCHO. Compared to wheat pasta, no significant effect on postprandial glucose iAUC was found for either test product. The iPkG was not reported.

For oatmeal and similar cereal preparations, four studies reported on 11 distinct comparisons. A significant reduction in glucose iAUC was observed in three of the 11 comparisons, i.e. with steel cut oats containing 1.71 g BG/30 g avCHO (−30.6%; Wolever et al. (2019)) and with two preparations of pearled oats, cooked under normal or high pressure, containing 1.86 g BG/30 g avCHO (−38.4% and −31.9%, respectively; Zhu et al. (2020)). No significant effect on glucose iAUC was reported in the other eight comparisons, which investigated various instant, old‐fashioned or whole grain oat preparations with doses ranging from 1.14 to 1.75 g BG/30 g avCHO (Wolever et al., 2018; Wolever et al., 2019; Wolever et al., 2020; Zhu et al., 2020). For iPkG, a significant reduction was reported in eight of the 11 comparisons, including the three preparations that also reduced glucose iAUC. Significant effects on iPkG were also observed with four instant oatmeal comparisons at beta‐glucan doses from 1.17 to 1.70 g/30 g avCHO (reductions of −10.7% to −21.3%; Wolever et al. (2018); Wolever et al. (2020)), and old‐fashioned oats at a dose of 1.69 g BG/30 g avCHO (−16.1%; Wolever et al. (2019)). No significant reduction in iPkG was seen in the remaining two comparisons (Wolever et al., 2019; Zhu et al., 2020).

The Panel notes that the results on postprandial glucose iAUC within the 1 g to < 2 g beta‐glucan dose range are inconsistent, with a significant reduction reported in five of the 19 available comparisons (26%), while a significant reduction in iPkG was observed in nine comparisons (out of 15; 60%) from five studies.

Trial comparisons testing ≥ 2 g to < 3 g of beta‐glucans per 30 g of available carbohydrates

Seventeen studies, including 29 distinct comparisons, investigated beta‐glucan doses between 2 g and < 3 g per 30 g of avCHO on postprandial glucose responses. Table 3 provides a summary of the test and control foods used in these studies, the beta‐glucan doses tested and the results regarding the postprandial iAUC for glucose and in the iPkG (when assessed).

TABLE 3.

Summary of trial comparisons testing foods with beta‐glucan doses between ≥ 2 and < 3 g/30 g avCHO and postprandial glucose responses. ^a

Reference	Test food	Control food	BG dose g/30 g avCHO	Mean % iAUC (120 min) difference vs control	Mean % iPkG difference vs control
Bread‐type products
Cavallero et al. (2002)	Barley sieved fraction bread	Wheat bread	2.39	ns	ns
Thondre and Henry (2011)	Wheat chapati + BG barley concentrates (Glucagel®)	Wheat chapati	2.40	ns	NR
Thondre and Henry (2009)	Wheat chapati + BG barley concentrates (Barley balance®)	Wheat chapati	2.40	−40	NR
Hartvigsen et al. (2014)	Wheat bread with concentrated BG	Wheat bread	2.52	−19.4	NR b
Finocchiaro et al. (2012)	Barley flour bread (Priora)	Wheat bread	2.88	−30.9	NR
Östman et al. (2006)	Barley bread (35% Prowashonupana)	Wheat bread	2.91	ns	NR
Ekström et al. (2017)	Oat bread	Wheat bread	2.95	−35.9	−32.6
Pasta products
Chillo et al. (2011)	Semolina pasta + BG barley concentrates (Glucagel®)	Durum semolina pasta	2.61	ns	NR
	Semolina pasta + BG barley concentrates (Barley balance®)		2.75	ns	NR
Holm et al. (1992)	Durum semolina pasta + oat bran	Durum semolina pasta	2.89	ns	ns
Cereal preparations
Wolever et al. (2018)	Instant oatmeal	Cream of rice	2.12	ns	−28.3
Zhu et al. (2020)	Whole grain oats (normal pressure)	Cooked rice	2.28	−39.7	−34.3
	Whole grain oats (high pressure)		2.28	−39.3	−34.3
Wolever et al. (2020)	Instant oatmeal + oat bran	Cream of rice	2.34	−42.2	−43.7
	Instant oatmeal + oat bran + beta‐glucanase		2.34	ns	−21
Wolever et al. (2018)	Instant oatmeal	Cream of rice	2.96	−20.6	−40.6
Biscuits and muesli
Granfeldt et al. (2008), series 2 c	Muesli (with oat bran flakes) + composite meal c	Muesli + composite meal d	2.40	−29.3	NR
Casiraghi et al. (2006)	Barley cookies	Wheat cookie	2.63	−51.6	NR
Beverages
Kwong et al. (2013a)	Oat drink (LMW)	Glucose drink	2.40	−25.2	−21.2
	Oat drink (HMW)		2.40	−36.4	−34.6
	Oat viscoelastic gel (LMW)	Glucose gel	2.40	ns	ns
	Oat viscoelastic gel (2 g HMW+ 2 g LMW)		2.40	ns	ns
	Oat viscoelastic gel (3 g HMW + 1 g LMW)		2.40	ns	−19.8
Kwong et al. (2013b)	Oat drink (LMW), 250 mL	Glucose drink	2.40	ns	ns
	Oat drink (LMW), 600 mL		2.40	ns	ns
	Oat drink (HMW), 250 mL		2.40	ns	−21.9
	Oat drink (HMW), 600 mL		2.40	ns	−27
Panahi et al. (2007)	Glucose drink + enzyme extract oat BG	Glucose drink e	2.40	−16.8	NR
	Glucose drink+ aqueous extract oat BG		2.40	ns	NR

Note: Different colours are used to differentiate between significant and non‐significant results.

Abbreviations: avCHO, available carbohydrates; BG, beta‐glucan; HMW, high molecular weight; iAUC, incremental area under the curve; iPkG, incremental peak glucose; LMW, low molecular weight; NR, not reported; ns, non‐statistically significant.

^a Trial comparisons sorted by type of food and beta‐glucan dose.

^b Only the maximum absolute postprandial blood glucose concentration is reported in the publication.

^c The study contained two experimental series. Only series 2 is relevant for the assessment.

^d Meal consisting of yogurt and white bread with cheese and butter.

^e Added to the glucose control drink were 8 g of fructooligosaccharides and 3 g of wheat bran (fibre matched).

Among studies employing bread‐type products, seven comparisons from seven studies were identified. A significant reduction in postprandial glucose iAUC was reported for an oat bread containing 2.95 g BG/30 g avCHO (−35.9%; Ekström et al. (2017)), a barley flour bread containing 2.88 g BG/30 g avCHO (−30.9%; Finocchiaro et al. (2012)), a wheat bread with concentrated beta‐glucan containing 2.52 g BG/30 g avCHO (−19.4%; Hartvigsen et al. (2014)), and a wheat chapati enriched with a barley concentrate containing 2.40 g BG/30 g avCHO (−40%; Thondre and Henry (2009)). No significant effect was observed in the three other studies, which tested various barley breads, or an enriched chapati, with beta‐glucan doses ranging from 2.39 to 2.91 g/30 g avCHO (Cavallero et al., 2002; Östman et al., 2006; Thondre & Henry, 2011). For iPkG, a significant reduction was reported with the oat bread containing 2.95 g BG/30 g avCHO (−32.6%; Ekström et al. (2017)), while no significant effect was observed with barley sieved fraction bread containing 2.39 g BG/30 g avCHO (Cavallero et al. (2002). This endpoint was not reported in the other five comparisons.

In two studies involving pasta products, no significant effect on the glucose iAUC was reported for three comparisons within the beta‐glucan dose range of 2.61 to 2.89 g/30 g avCHO. One study (Chillo et al., 2011) tested two barley beta‐glucan‐enriched semolina pastas (at 2.61 and 2.75 g BG/30 g avCHO) and the second study (Holm et al., 1992) a durum semolina pasta enriched with oat bran (2.89 g BG/30 g avCHO). No effect on the iPkG was observed in the only study assessing this endpoint (Holm et al., 1992).

Three studies focused on oatmeal and similar cereal preparations (six distinct comparisons), with significant reductions in glucose iAUC reported in four comparisons. These effects were observed with instant oatmeal containing 2.34 g BG/30 g avCHO (−42.2%; Wolever et al. (2020)) and 2.96 g BG/30 g avCHO (−20.6%; Wolever et al. (2018)), and with two preparations of whole grain oats containing 2.28 g BG/30 g avCHO (−39.7% and − 39.3%, respectively; Zhu et al. (2020)). No significant effect on glucose iAUC was observed with an instant oatmeal containing enzymatically degraded beta‐glucan (2.34 g BG/30 g avCHO; Wolever et al., 2020) or with another instant oatmeal containing a lower dose of 2.12 g BG/30 g avCHO (Wolever et al., 2018). For iPkG, a significant reduction was reported in all six comparisons. These included the four preparations that also reduced iAUC (with reductions ranging from −34.3% to −43.7%; Wolever et al. (2020); Wolever et al. (2018); Zhu et al. (2020)), an instant oatmeal with degraded beta‐glucan (−21%; Wolever et al. (2020)) and the instant oatmeal containing 2.12 g BG/30 g avCHO (−28.3%; Wolever et al. (2018)).

Casiraghi et al. (2006) reported a 51.6% reduction in glucose iAUC with barley cookies containing 2.63 g BG/30 g avCHO when compared to a wheat cookie control. Muesli including oat bran flakes was found to significantly reduce glucose iAUC by 29.3% at a dose of 2.4 g BG/30 g avCHO compared to the same muesli without oat bran flakes, both consumed with a composite meal (Granfeldt et al. (2008), series 2).

Regarding the effect of beta‐glucans in beverages, three studies reported on 11 distinct comparisons, all at a dose of 2.4 g BG/30 g avCHO. For postprandial glucose iAUC, a significant reduction was reported in three of the 11 comparisons. These effects were observed with two glucose drinks containing low or high oat MW beta‐glucan (−25.2% and −36.4%, respectively; Kwong et al. (2013a)) and with a viscous, enzyme‐extracted oat beta‐glucan glucose drink (−16.8%; Panahi et al. (2007)). No significant effect on glucose iAUC was reported in the remaining eight comparisons, which included three trial comparisons testing viscoelastic gels (Kwong et al., 2013a), four glucose drinks enriched with purified oat beta‐glucan (Kwong et al., 2013b) and a low‐viscosity glucose drink also enriched with oat beta‐glucans (Panahi et al., 2007). For iPkG, which was reported in nine of these 11 comparisons, a significant reduction was observed in five. Two of these statistically significant findings occurred with the two glucose drinks containing low and high‐MW oat beta‐glucan that also showed a significant glucose iAUC reduction (Kwong et al., 2013a). The other three test products were a viscoelastic gel with a high proportion of high‐MW oat beta‐glucan (Kwong et al., 2013a) and two high‐MW oat beta‐glucan beverages tested at different volumes (Kwong et al., 2013b). No effect on iPkG was observed in the remaining four comparisons where this endpoint was assessed.

The Panel notes that the results on postprandial glucose iAUC within the 2–< 3 g/30 g avCHO beta‐glucan dose range are inconsistent, with a significant reduction reported in 13 of the 29 available comparisons (45%). The inconsistency of the effect has been observed for solid foods (bread and cereal preparations) and notably for beverages, for which the same dose of beta‐glucans (2.4/30 g avCHO) has been tested in all 11 comparisons from three studies. Regarding iPkG, the evidence was more consistent, with a significant reduction reported in 12 (67%) of the 18 comparisons where this endpoint was assessed. The Panel also notes a clear pattern within the 18 comparisons where both endpoints were reported: a significant reduction in glucose iAUC (7 comparisons) was always accompanied by a significant reduction in iPkG, and an additional five comparisons showed a reduction in iPkG alone, with no instances reporting reduction in the iAUC in the absence of a corresponding reduction in iPkG.

Trial comparisons testing ≥ 3 g to < 4 g of beta‐glucans per 30 g of available carbohydrates

Four studies, comprising five distinct comparisons, investigated beta‐glucan doses between 3 g and < 4 g per 30 g avCHO on postprandial glucose responses. Table 4 provides a summary of the test and control foods used in these studies, the beta‐glucan doses tested and the results regarding the postprandial iAUC for glucose and in the iPkG (when assessed).

TABLE 4.

Summary of trial comparisons testing foods with beta‐glucan doses ≥ 3 to < 4 g and postprandial glucose responses. ^a

Reference	Test product	Control food	BG dose g/30 g avCHO	Mean % iAUC (120 min) difference versus control	Mean % iPkG difference versus control
Bread‐type products
Finocchiaro et al. (2012)	Barley flour bread (CDC Alamo)	Wheat bread	3.18	ns	NR
Cavallero et al. (2002)	Barley water‐extracted fraction bread	Wheat bread	3.56	−27.8	ns
Thondre and Henry (2009)	Wheat chapati + BG barley concentrates (Barley balance®)	Wheat chapati	3.6	ns	NR
Pasta products
Chillo et al. (2011)	Semolina pasta + BG barley concentrates (Glucagel®)	Durum semolina pasta	3.51	ns	NR
	Semolina pasta + BG barley concentrates (Barley balance®)		3.67	−42.6	NR

Note: Different colours are used to differentiate between significant and non‐significant results.

Abbreviations: avCHO, available carbohydrates; BG, beta‐glucan; CDC, Crop Development Center; iAUC, incremental area under the curve; iPkG, incremental peak glucose; NR, not reported; ns, non‐statistically significant.

^a Trial comparisons sorted by type of food and beta‐glucan dose.

Three studies provided comparisons using bread‐type products. A significant reduction in glucose iAUC (−27.8%) was observed with a beta‐glucan‐enriched bread made from a water‐extracted barley fraction providing 3.56 g BG/30 g avCHO (Cavallero et al., 2002), but not with a barley bread providing 3.18 g BG/30 g avCHO (Finocchiaro et al., 2012), both compared to a wheat bread control. The third study (Thondre & Henry, 2009) tested 3.6 g BG /30 g avCHO in wheat chapati against a control wheat chapati and found no significant effect on glucose iAUC. No significant effect of beta‐glucans on iPkG was reported in the only study that assessed this endpoint (Cavallero et al., 2002).

One study compared pasta enriched with two different barley beta‐glucan concentrates (‘Barley balance®’ and ‘Glucagel®’) to a control durum semolina pasta (Chillo et al., 2011). The pasta enriched with ‘Barley balance®’ beta‐glucans (3.67 g/30 g avCHO) showed a significant reduction in glucose iAUC (−42.6%), whereas the pasta enriched with ‘Glucagel®’ beta‐glucans (3.51 g BG/30 g avCHO) did not. The iPkG was not reported in this study.

The Panel notes that the results on postprandial glucose iAUC within the 3 to < 4 g beta‐glucan dose range are inconsistent, with a significant reduction reported in two of the five available comparisons (40%). The effect of beta‐glucans on the iPkG was reported in one study only and it was not statistically significant.

Studies investigating dose–response relationships between the intake of beta‐glucans and postprandial blood glucose responses

The Panel further examined the evidence for a dose–response relationship by focusing on the five studies (six dose–response relationships) that investigated three or more beta‐glucan doses (Cavallero et al., 2002; Chillo et al., 2011; Thondre & Henry, 2009; Wolever et al., 2018; Zhu et al., 2020).

In three studies on barley bread (1.19, 2.39 and 3.56 g/30 g avCHO) (Cavallero et al., 2002), barley pasta (0.91, 1.76, 2.75 and 3.67 g/30 g avCHO from Barley Balance®) (Chillo et al., 2011) and instant oatmeal with oat bran (1.27, 1.48, 1.70, 2.12 and 2.96 g/30 g avCHO) (Wolever et al., 2018), a significant reduction in postprandial glucose iAUC was observed only at the highest dose tested in each study (−27.8%, −42.6% and −20.6%, respectively). In Chillo et al. (2011), another pasta enriched with the ‘Glucagel®’ concentrate showed no significant effect at any of the four beta‐glucan doses tested between 0.89 and up to 3.51 g/30 g avCHO. In the study by Zhu et al. (2020) on pearled oats and grain oats cooked under normal or high pressure (0.96, 1.14, 1.86, 2.28 g/30 g avCHO), a reduction in glucose iAUC was observed at the two highest doses tested (from −31.9% to −39.7%). In the study by Thondre and Henry (2009) on wheat chapati and barley concentrates (1.2, 2.4 and 3.6 g/30 avCHO), only the middle dose resulted in a significant reduction in glucose iAUC (−40%) and thus the lowest effective dose of beta‐glucans for a significant reduction in the glucose iAUC could not be established in this study.

Only two of the above‐mentioned studies reported on iPkG. Wolever et al. (2018) demonstrated a clear graded dose–response, with the magnitude of the iPkG reduction increasing progressively (from 10.7% up to 40.6%) across all five doses of beta‐glucans tested (1.27, 1.48, 1.70, 2.12, 2.96 g/30 g avCHO). The other study (Zhu et al., 2020) reported significant reductions in iPkG at the two highest doses of beta‐glucans tested (1.86 and 2.28 g/30 g avCHO) and not at the lower two doses (0.96 and 1.14 g/30 g avCHO), also suggesting a dose–response relationship between the intake of beta‐glucans and a reduction of the iPkG.

The Panel notes that, in the dose–response studies available, the lowest effective dose of beta‐glucans for a significant reduction in the postprandial glucose iAUC was from 2.96 to 3.67 g/30 g avCHO in three studies (four dose–response relationships; Cavallero et al. (2002); Chillo et al. (2011); Wolever et al. (2018)), and 1.86 g/30 g avCHO in one study (Zhu et al., 2020).

3.3.1.2. Dose–response meta‐analyses

The applicant performed a dose–response meta‐regression analysis using data from 19 trials (55 comparisons) that used a matched comparator. The Shapiro Wilk's test was used to evaluate the normal distribution of the residuals. No other information about the methodology used to conduct this analysis, including the statistical model used, was provided upon EFSA's request. The Panel considers that no conclusions can be drawn from this dose–response meta‐regression analysis to derive the lowest effective dose of beta‐glucans for a reduction of postprandial glucose responses.

The applicant also provided four systematic reviews and dose–response meta‐regression analyses on the relationship between the intake of beta‐glucans and postprandial blood glucose responses (AbuMweis et al., 2016; Noronha et al., 2023; Tosh, 2013; Zurbau et al., 2021) as supportive evidence.

The first systematic review (Tosh, 2013) selected controlled, randomised, blinded, crossover or parallel human studies, which included information on available carbohydrate dose, oats or barley beta‐glucan or soluble fibre dose, and postprandial blood glucose responses assessed as the glucose iAUC (compared to a glucose solution or a matched control) or the GI (as compared to a glucose solution). Where a glucose drink was used as a control for solid foods, the data were adjusted to simulate a hypothetical control of white bread with a GI of 71. Studies in patients with diabetes and trial comparisons in which the beta‐glucan MW was reduced deliberately to < 250 kDa, and those with high levels of resistant starch were excluded.

A total of 34 studies (119 trial comparisons) were eligible. The dose of beta‐glucan in the interventions ranged from 0.3 to 12.1 g per meal and the dose of available carbohydrates ranged from 25 to 100 g per meal. The number of trials with a parallel design is not reported in the review. The iAUC over 120 min was reported (or could be calculated) for all the studies except one. That study calculated the iAUC over 60 min but it was included in the analysis because glucose concentrations had returned to baseline. Sample size was between 5 and 20 participants. A reduction of glycaemic responses equivalent to a change in GI > 15 units was considered of biological relevance, which would correspond to an average change in the glucose iAUC of 27 mmol × min/L. All products containing 4 g beta‐glucan/30 g avCHO showed a significant reduction in glucose iAUC (27 processed and 2 intact kernels), whereas only 55% (16 processed and 23 intact kernels) did so at lower doses. The meta‐regression predicted a reduction in glucose iAUC of 5.2 ± 0.6 mmol × min/L for each gram of beta‐glucan included in a meal. A physiologically relevant reduction of 27 mmol × min/L was attained with a dose of 4.0 g beta‐glucan (range of avCHO in test meals between 25 and 100 g), suggesting that the lowest effective dose may be lower than 4 g BG/30 g avCHO. Considering that these products contained an average of 51 g avCHO, the Panel notes that the lowest effective dose of beta‐glucans expressed in terms of avCHO content could be around 2.4 g, which is above the conditions of use proposed by the applicant. The Panel also notes that this dose has been calculated by considering a 15% reduction in the glucose iAUC, which is below the 20% achieved in virtually all the matrix‐matched comparisons which showed a significant effect of beta‐glucans on glucose iAUC in the individual human intervention studies that were submitted by the applicant as pertinent to the claim (Section 3.3.1.1), and that studies in which the beta‐glucan MW was reduced deliberately to < 250 kDa were excluded.

In the second dose–response meta‐analysis (AbuMweis et al., 2016), study selection was restricted to trials on barley products or beta‐glucans from barley and included glucose iAUC data from 11 trials (beta‐glucan doses between 0.9 to 9.2 g/30 g avCHO). A variety of food products were tested (e.g. pasta, muffins, bread, soups) versus matched (e.g. same foods without beta‐glucans) and unmatched (e.g. glucose) comparators. Multiple comparisons or strata within the same study were combined using a fixed‐effects model, and then random‐effects models were used to obtain an overall estimate of the effect of the intervention on the outcomes of interest for each study. The meta‐analysis showed a significant effect of barley beta‐glucans on glucose iAUC, also when the analysis was restricted to studies using matched control foods (n = 7). However, no significant dose–response relationship between the intake of barley beta‐glucans and the postprandial glucose iAUC was observed in the dose–response meta‐analysis (n = 11 studies), possibly owing to the few data points available using this study‐based (rather than individual comparison‐based) analysis and the large heterogeneity regarding both the test and the control foods used, as discussed by the authors. The Panel notes that the model used to conduct the meta‐regression analysis is not described in the publication.

A large meta‐analysis (Zurbau et al., 2021) included 35 acute, crossover, controlled feeding trials (involving 103 trial comparisons and 538 participants) investigating the effect of oat beta‐glucans in CHO‐containing meals as compared to comparable or different meals matched by the avCHO content without beta‐glucans, in humans regardless of the health status. Trial comparisons including participants with type 2 diabetes (n = 11), metabolic syndrome (n = 1) or overweight (n = 14) were included. Oat beta‐glucans were added to a variety of foods including muffins, glucose/dextrose solutions and gels, cereals, porridges, muesli, fruit juices, snack bars and pasta. Studies using oats or oat flour as the only source of beta‐glucans were excluded. The amount of beta‐glucans tested ranged from 0.1 to about 8.4 g/30 g avCHO, and up to 22.6 g/30 g avCHO in one study with oat bran flour in patients with type 2 diabetes (median 2.8 g/30 g avCHO). The duration of the glucose measurements ranged from 60 to 240 min. Data were pooled using generic inverse variance with random‐effects model and were expressed as ratio of means (95% CI).

The primary outcome was glucose iAUC. Secondary outcomes were insulin iAUC, iPkG and incremental insulin peak (iPkI). Significant dose–response relationships were observed for all endpoints. Dose, MW and the comparator were significant effect modifiers on glucose iAUC and iPkG. Using the 98 trial comparisons (508 participants) in which glucose iAUC was measured, it was estimated that each gram of oat beta‐glucans/30 g avCHO would reduce glucose iAUC by 8% (95% CI: 6%–9%, p < 0.001). The reduction of postprandial glucose iAUC was more pronounced for beta‐glucans in semi‐solid and solid foods than in beverages, and in unmatched vs. matched comparators, although the 95% CI overlapped. In subgroup analyses by MW, a significant dose–response was found for medium‐MW (300 to < 1000 kg/mol) and highMW beta‐glucans (p < 0.001), but not for low‐MW (< 300 kg/mol) beta‐glucans. Duration was also a significant effect modifier, with the largest reduction in glucose iAUC observed for a postprandial duration of 240 min (one study with 3 comparisons). The lowest oat beta‐glucans dose estimated to achieve a physiologically meaningful (e.g. ≥ 20%) reduction in glucose iAUC was > 3.5 g/30 g avCHO for the analysis from the 98 comparisons, and 2.9 g/30 g avCHO specifically for high‐MW beta‐glucans. Using the 34 trial comparisons (231 participants) in which glucose iPkG was measured, it was estimated that each gram of oat beta‐glucans/30 g avCHO would reduce iPkG by 9% (95% CI: 7%–11%, p < 0.001).

In a subsequent meta‐analysis by the same research group (Noronha et al., 2023) with similar objectives and methodology, trial comparisons with unmatched comparators (e.g. muffins vs. glucose or spaghetti vs. bread) were excluded. A total of 20 studies reporting on 59 trial comparisons (340 participants) met the inclusion criteria. Duration was 120 min in most trial comparisons (74%), with the remaining lasting 180 min. Only two trial comparisons involved participants with type 2 diabetes (T2DM), and one included individuals with metabolic syndrome. Within each beta‐glucan MW category, meta‐regression analyses were separated by health status and follow‐up duration (i.e. trials of 120 mins in participants without T2DM and trials of 120–180 mins in participants with and without T2DM). The amount of oat beta‐glucans tested ranged from 0.3 to 7 g/30 g avCHO (median 3.2 g/30 g avCHO). Dose–response relationships were investigated, within each beta‐glucans MW category only, in trials lasting 120 min in healthy individuals and in all trials combined (lasting 120–180 min including healthy participants and patients with type 2 diabetes).

When only studies in healthy individuals lasting 120 min were considered (45 trial comparisons), a significant linear dose–response relationship was observed for low‐ (< 300 kg/mol; p = 0.008), high‐MW (> 1000 kg/mol; p < 0.001) and medium‐MW oat beta‐glucans (300 to < 1000 kg/mol; after removal of one study) and glucose iAUC. Results were similar when all trials were included in the analysis. The lowest effective dose associated with a physiologically relevant 20% reduction in the postprandial glucose iAUC for high‐MW oat beta‐glucans was estimated to be 2.8 g/30 g avCHO and could not be calculated for medium‐ and low‐MW oat beta‐glucans. The lowest effective doses associated with a 20% reduction in the iPkG for medium‐MW and high‐MW oat beta‐glucans were 6.6 g and 1.7 g/30 g avCHO, respectively, and could not be calculated for low‐MW beta‐glucans.

The Panel notes that two meta‐analyses by the same research group (Noronha et al., 2023; Zurbau et al., 2021) found a statistically significant dose–response relationship between the amount of oat beta‐glucans consumed per 30 g avCHO and a reduction in postprandial glucose iAUC and iPkG. These two meta‐analyses (Noronha et al., 2023; Zurbau et al., 2021), including a high number of comparisons from several studies, estimate that the lowest dose from any oat beta‐glucan (> 3.5 g/30 g avCHO) or from highMW oat beta‐glucans (2.8–2.9 g/30 g avCHO) required to achieve a physiologically relevant reduction in postprandial glucose iAUC is above the 2 g/30 g avCHO proposed by the applicant. The results of a third meta‐analysis including studies on both oats and barley beta‐glucans are consistent with this conclusion (Tosh, 2013).

3.3.1.3. Conclusions on human intervention studies

In the human intervention studies provided by the applicant and described above, beta‐glucans from oats or barley significantly reduced postprandial blood glucose responses (iAUC for glucose) when compared to an appropriate control food at doses of < 1 g, 1 to < 2 g, 2 to < 3 g and 3 to < 4 g per 30 g avCHO in 0% (0 of 6), 26% (5 of 19), 45% (13 of 29) and 40% (2 of 5) of the trial comparisons in which they were tested, respectively. This suggests a dose–response relationship between the dose of BG per 30 g avCHO tested and the consistency of their effect in reducing postprandial blood glucose responses across a wide variety of food matrices tested against matched controls. The Panel notes that, with few exceptions, a statistically significant effect of beta‐glucans on the postprandial glucose iAUC corresponds to a mean reduction of ≥ 20% as compared to the control food, a reduction that is considered to be biologically relevant ² in the context of a mixed diet.

The Panel notes that, with only two exceptions (Cavallero et al., 2002; Rieder et al., 2019), all the comparisons for which a significant reduction in the glucose iAUC was observed also showed a significant decrease in the iPkG when this endpoint was reported. However, the opposite was not the case, as the evidence for an effect of beta‐glucans on the reduction of the iPkG was more consistent, with statistically significant reductions reported in 25% (1 of 4), 60% (9 of 15) and 67% (12 of 18) of the comparisons for the < 1 g, 1 to < 2 g, 2 to < 3 g BG/30 g avCHO dose ranges, respectively, also suggesting a dose–response relationship. Only one comparison was available for the 3 to < 4 g BG/30 g avCHO dose range.

Out of the five studies, which tested three or more doses of BG and were designed as dose–response studies, four studies (Cavallero et al., 2002; Chillo et al., 2011; Thondre & Henry, 2009; Wolever et al., 2018) suggested that the lowest effective dose of BG in the foods tested (e.g. barley bread, barley pasta, instant oatmeal with oat bran, chapati and barley concentrates) for the reduction of glucose iAUC may be above the 2 g/30 g avCHO proposed by the applicant. This is supported by the results of three dose–response meta‐analyses (Noronha et al., 2023; Tosh, 2013; Zurbau et al., 2021). The few dose–response studies (Wolever et al., 2018; Zhu et al., 2020) and meta‐analyses (Noronha et al., 2023; Zurbau et al., 2021) reporting on iPkG suggest that the lowest effective dose of beta‐glucans to achieve a significant reduction in this endpoint may be lower as compared to that required to obtain a significant and biologically relevant reduction in the glucose iAUC, which provides a better summary of postprandial glycaemia.

The Panel considers that the human intervention studies and meta‐analyses thereof submitted by the applicant do not show a consistent effect of beta‐glucans from oats or barley on postprandial glucose responses assessed by the postprandial glucose iAUC under the proposed conditions of use of at least 2 g BG/30 g avCHO.

3.3.2. Mechanism of action

The mechanism by which beta‐glucans from oats or barley could exert the claimed effect is well established and relates to the ability of beta‐glucans to form viscous solutions, i.e. to increase the viscosity of the meal bolus when beta‐glucans are added. The increased viscosity induced by beta‐glucans may delay gastric emptying (Wolever et al., 2020), and when the meal bolus reaches the small intestine, a high viscosity delays the rate of absorption of nutrients, including glucose (Battilana et al., 2001; EFSA NDA Panel, 2011; Wood et al., 2000; Würsch & Pi‐Sunyer, 1997).

The mixed linkages (1,3‐ or 1,4‐glycosydic bonds) of beta‐glucans are important for their physical properties, such as solubility and viscosity. Their viscosity is a function of the concentration of dissolved beta‐glucans, and of their MW (Wood et al., 2000), and further depends on differences in raw materials, processing and can vary across different methods of determination (EFSA NDA Panel, 2011).

The applicant claims that there is evidence that higher viscosity of oat food products owing to a higher MW of beta‐glucans leads to lower glycaemic responses. The Panel notes that this statement is supported by the two meta‐analyses provided (Noronha et al., 2023; Zurbau et al., 2021), which suggest that the lowest effective dose for a significant reduction of postprandial glucose responses (as assessed by the glucose iAUC) may be lower for beta‐glucans with high‐ vs. medium‐ or low‐MW. However, the Panel also notes that the authorised claim for which a modification is requested applies to beta‐glucans from oats and barley in general, either naturally present in foods or added to foods (including beverages), the MW of which generally ranges from 50 to 2000 kDa, with no restrictions (EFSA NDA Panel, 2011).

3.3.3. Weighing of the evidence

The Panel considers that the iAUC for glucose is the appropriate endpoint for the scientific substantiation of health claims on the reduction of postprandial blood glucose responses made on food, and that other PG measurements (e.g. iPkG) can only be used as supportive evidence for the scientific substantiation of these claims.

In weighing the evidence, the Panel took into account that, in the 21 human intervention studies provided by the applicant which investigated the effect of oats or barley beta‐glucans in foods (and beverages) on postprandial blood glucose responses as compared to matched control foods (59 trial comparisons), no consistent effect of beta‐glucans on the postprandial glucose iAUC was observed at doses between 2 and < 4 g/30 g avCHO (i.e. a significant effect of the test vs. the control foods was reported in less than 50% of the available comparisons). The Panel notes that most studies showing a significant effect of beta‐glucans on the glucose iAUC also report a significant effect on the iPkG when this endpoint was reported, whereas the opposite was not the case. The effect of beta‐glucans on iPkG was more consistent than on iAUC across dose ranges of beta‐glucans in the sub‐set of studies, which reported on both endpoints.

The Panel also took into account that four studies testing three or more doses of beta‐glucans (Cavallero et al., 2002; Chillo et al., 2011; Thondre & Henry, 2009; Wolever et al., 2018) suggested that the lowest effective dose in the foods tested (e.g. barley bread, barley pasta, instant oatmeal with oat bran, chapati and barley concentrates) for the reduction of glucose iAUC may be above the 2 g/30 g avCHO proposed by the applicant. This is also supported by the results of three published dose–response meta‐analyses (Noronha et al., 2023; Tosh, 2013; Zurbau et al., 2021). The few dose–response studies (Wolever et al., 2020; Zhu et al., 2020) and meta‐analyses (Noronha et al., 2023; Zurbau et al., 2021) reporting on iPkG also suggest that the lowest effective dose of beta‐glucans needed to achieve a significant reduction in this endpoint may be lower as compared to that required to obtain a significant and biologically relevant reduction in the glucose iAUC, which however provides a better summary of postprandial glycaemia.

Finally, the Panel notes that, although it is well established that the mechanism by which beta‐glucans exert the claimed effect relates to their ability to form viscous solutions in the GI tract, which in turn depends on their MW and concentration among other factors, the authorised claim for which a modification is requested applies to beta‐glucans from oats and barley in general, either naturally present in foods or added to foods (including beverages) the MW of which generally ranges from 50 to 2000 kDa, with no restrictions (EFSA NDA Panel, 2011).

The Panel concludes that a consistent effect of beta‐glucans from oats or barley on the reduction of postprandial glycaemic responses has not been demonstrated under the conditions of use proposed by the applicant of at least 2 g beta‐glucans/30 g avCHO consumed with a meal.

4. CONCLUSIONS

On the basis of the data presented, the Panel concludes that:

• The food/constituent, beta‐glucans from oat and barley, is sufficiently characterised.

• The claimed effect proposed by the applicant is ‘reduction of post‐prandial blood glucose responses’. The target population proposed by the applicant is ‘individuals who wish to reduce their post‐prandial glycaemic responses’. The Panel considers the reduction of postprandial glycaemic responses to be a beneficial physiological effect (e.g. for individuals with IGT), as long as postprandial insulinemic responses are not disproportionally increased. The reduction of postprandial glycaemic responses is a beneficial physiological effect in the context of the food/constituent and the target population for this claim.

• The Panel concludes that a consistent effect of beta‐glucans from oats or barley on the reduction of postprandial glycaemic responses has not been demonstrated under the conditions of use proposed by the applicant of at least 2 g beta‐glucans/30 g avCHO consumed with a meal.

DOCUMENTATION AS PROVIDED TO EFSA

Health claim application on “Beta‐glucans from oats or barley and reduction of postprandial glycaemic responses: modification of an authorised health claim pursuant to Article 13(1) of Regulation (EC) No 1924/2006 following a request in accordance with Article 19 of Regulation (EC) No 1924/2006” (Appian number: HC‐2024‐23552). Submitted by PepsiCo International.

STEPS TAKEN BY EFSA

1. This application was received by EFSA on 22/11/2024. The application was validated on 10/02/2025 and the scientific evaluation started.

2. The scope of the application was proposed to fall under a modification of the conditions of use of an authorised Article 13(1) claim in accordance with Article 19 of Regulation (EC) No 1924/2006.

3. The Working Group on Claims of the NDA Panel agreed on a list of questions for the applicant to provide additional information to accompany the application. EFSA sent a first Additional Data Request (ADR1) letter to the Applicant on 12/3/2025. The clock was stopped on 12/3/2025 and restarted on 27/03/2025. A second ADR was sent on 26/5/2025. The clock was stopped on 26/5/2025 and restarted on 10/6/2025. A third ADR was sent on 8/7/2025. The clock was stopped on 8/7/2025 and restarted on 23/7/2025.

4. During its meeting on 27/8/2025, the NDA Panel, having evaluated the data, adopted an opinion on the scientific substantiation of a health claim related to ‘Beta‐glucans from oats or barley and reduction of post‐prandial glycaemic responses’.

ABBREVIATIONS

ADR

additional data request

Art.

Article

avCHO

available carbohydrates

BG

beta‐glucans

CI

confidence intervals

CoU

conditions of use

CVD

cardiovascular diseases

FPG

fasting plasma glucose

GI

glycaemic index

GLUT

glucose transporter type

HbA1c

glycated haemoglobin

hs‐CRP

high sensitivity C‐reactive protein

iAUC

incremental area under the curve

IGT

impaired glucose tolerance

IMT

intima‐media thickness

iPkG

incremental peak glucose

IPkI

incremental insulin peak

MW

molecular weight

NDA

Nutrition, Novel Foods and Food Allergens (Panel)

NGT

normal glucose tolerance

NR

not reported

ns

non‐significant

OGTT

oral glucose tolerance test

PAI‐1

plasminogen activator inhibitor‐1

PC

Public Consultation

PG

plasma glucose

PGS

post‐challenge glucose spikes

PICO

Population, Intervention, Comparator, Outcome

RCT

randomised controlled trial

SGLT

sodium‐glucose cotransporter type

T2DM

type 2 diabetes mellitus

REQUESTOR

Competent Authority of Ireland following an application by PepsiCo International Ltd.

QUESTION NUMBER

EFSA‐Q‐2024‐00674.

COPYRIGHT FOR NON‐EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

PANEL MEMBERS

Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Angeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani and Frank Thies.

APPENDIX A. Outcome of the public consultation on the Application on ‘Beta‐glucans from oats or barley and reduction of post‐prandial glycaemic responses’ (HC‐2024‐23552)

One comment was submitted by one contributor from United Kingdom. The comment is published on the EFSA web page as received (https://connect.efsa.europa.eu/RM/s/consultations/publicconsultation2/a0lTk000003mKyn/pc1330).

Contributor/organisation

Comment and reply

UKNHCC Secretariat, Office for Health Improvement and Disparities (OHID), Department of Health and Social Care (DHSC) (United Kingdom)

Comment: ‘Please find attached and link to the UK Nutrition and Health Claims Committee (UKNHCC) scientific opinion on the modification of the authorisation of a health claim related to beta‐glucan from oats or barley and the reduction of the blood glucose rise after a meal https://www.gov.uk/government/publications/uknhcc‐scientific‐opinion‐beta‐glucan‐from‐oats‐or‐barley‐andreduction‐of‐blood‐glucose‐rise‐after‐a‐meal Attachment contains the scientific opinion from the UK Nutrition & Health Claims Committee (UKNHCC) on the modification of the authorisation of a health claim related to beta‐glucan from oats or barley and the reduction of the blood glucose rise after a meal pursuant to Article 13(1) of Regulation (EC) No 1924/20061 following a request in accordance with Article 19 of retained Regulation (EC) No 1924/20061, as amended by the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 and the Nutrition (Amendment etc.) (EU Exit) Regulations 2020 Reply: EFSA acknowledges the UK Authority's assessment

APPENDIX B. Overview of studies on postprandial glycaemia and beta‐glucans

TABLE B.1.

Summary of studies investigating the effects of oat and barley beta‐glucan on postprandial glycaemic responses.

Reference	Washout duration	N	Test product	BG dose g/avCHO g	BG dose g/30 g avCHO	MW (kDa)	Control (g BG/avCHO g)	Mean % iAUC (120 min) difference versus control	Mean % iPkG difference versus control
Casiraghi et al. (2006)	2 weeks	10	Barley cookies	3.5/40	2.63	NR	Wheat cookie (0.2/40)	−51.6; s	NR a
			Barley cracker	3.6/43.1	2.51	NR	Wheat cracker (0.4/39.5)	Excluded: > 1 g difference in avCHO
Cavallero et al. (2002)	NR	8	Barley flour bread	1.98/50	1.19	NR	Wheat bread (0.07/50)	−0.78, ns (calculated using GI values)	−5.6, ns b
			Sieved fraction bread	3.98/50	2.39	NR	Wheat bread (0.07/50)	−18.25, ns (calculated using GI values)	−6, ns b
			Water‐extracted fraction bread	5.93/50	3.56	NR	Wheat bread (0.07/50)	−27.8; s (calculated using GI values)	−5.6, ns b
Chillo et al. (2011)	≥ 1 day	9	Semolina pasta + BG barley concentrates (Glucagel®)	1.49/50	0.89	150	Durum semolina pasta (0/50)	−8.7; ns	NR a
				2.88/50	1.73			−4.6; ns
				4.35/50	2.61			−32.6; ns
				5.85/50	3.51			−3.5; ns
				7.23/50	4.34	150	Durum semolina pasta (0/50)	Excluded: BG dose > 4 g/30 g CHO
			Semolina pasta + BG barley concentrates (Barley balance®)	1.52/50	0.91	650–700	Durum semolina pasta (0/50)	−19.3; ns	NR a
				3.01/50	1.81			−25.7; ns
				4.59/50	2.75			−31.9; ns
				6.11/50	3.67			−42.6; s
				7.66/50	4.60			Excluded: BG dose > 4 g/30 g CHO
Ekström et al. (2017)	≥ 1 week	13	Oat bread 1	3.4/53.2	1.92	174–282	White wheat bread (0/52.9)	−37.5; s	−34.9; s
			Oat bread 2	5.2/52.9	2.95	Unclear		−35.9; s	−32.6; s
			Oat bread 3	7.5/54.72	4.11	205–291	White wheat bread (0/52.9)	Excluded: BG dose > 4 g/30 g avCHO and > 1 g difference in avCHO
Finocchiaro et al. (2012)	3 days	9	Barley flour bread (CDC Alamo)	5.3/50	3.18	NR	Wheat bread (0.2/50)	−15.3; ns (calculated using GI values)	NR c
			Barley flour bread (Priora)	4.8/50	2.88	NR	Wheat bread (0.2/50)	−30.9; s (calculated using GI values)	NR c
Granfeldt et al. (2008), serie 2	1 week	13	Muesli (with oat bran flakes) and yogurt, white bread with cheese and butter	4/50	2.4	NR	Muesli (without oat bran flakes) and yogurt, white bread with cheese and butter (0/50)	−29.3; s	NR a
Hartvigsen et al. (2014)	1 week	15 metS	Wheat bread with concentrated b‐glucan	4.2/50	2.52	1978	Wheat bread (0.2/50)	−19.4; s	NR d
Holm et al. (1992)	NR	10	Durum semolina pasta + oat bran	5.2/54.2	2.89	NR	Durum semolina pasta (0.12/54.2)	−16.6; ns	−18.2; ns
Kwong et al. (2013a)	NR	15	Oat drink (LMW)	4/50	2.4	145	Glucose drink or gel (0/50)	−25.2; s	−21.2; s
			Oat drink (HMW)			580		−36.4; s	−34.6; s
			Oat viscoelastic gel (LMW)			145		−5.4; ns	−5.1; ns
			Oat viscoelastic gel (2 g HMW + 2 g LMW)			362.5		−16.3; ns	−17.1; ns
			Oat viscoelastic gel (3 g HMW + 1 g LMW)			471.25		−14; ns	−19.8; s
Kwong et al. (2013b)	NR	15	Oat drink (LMW) 250 mL	4/50	2.4	145	Glucose drink, 250 mL or 600 mL	−7.4; ns	−3.7; ns
			Oat drink (LMW) 600 mL					−8.7; ns	−12.2; ns
			Oat drink (HMW), 250 mL			580		−12.1; ns	−21.9; s
			Oat drink (HMW), 600 mL					−14.5; ns	−27; s
Östman et al. (2006)	1 week	10	50% common barley bread	1.07/30	1.07	NR	White wheat bread (0.07/30)	Values NR; ns	NR a
			35% Prowashonupana barley bread	2.91/30	2.91	NR		Values NR; ns	NR a
			50% PW barley bread	4.58/30	4.58	NR		Excluded: BG dose > 4 g/30 g avCHO
			75% PW barley bread	9.16/30	9.16	NR		Excluded: BG dose > 4 g/30 g avCHO
Panahi et al. (2007)	≥ 3 days	11	Glucose drink + enzyme extract oat BG (A)	6/75	2.4 (viscosity maintained)	NR	Glucose drink +8 g fructooligosaccharide +3 g WB (fibre matched), (0/75)	−16.8; s	NR a
			Glucose drink + aqueous extract oat BG (B)		2.4 (low viscosity)			−6.4; ns	NR a
Paquin et al. (2013)	≥ 1 week	14M	Oat BG concentrate + fruit juice	1.14/35	0.98	NA	Fruit juice, (0/35)	−31.4; ns	−22.7; s
Regand et al. (2009)	≥ 1 day	12	Oat crisp bread	4/64	1.88	197	Wheat crisp bread (B), (1/65)	+6.5; ns	−1.4; ns PW:
			Oat pasta	4/42	2.85	465	Wheat pasta (A), (0.4/44)	Excluded: > 1 g difference in avCHO
			Oat porridge	4/43	2.79	1942	Wheat muffin (C), (0.2/46)	Excluded: > 1 g difference in avCHO & control not comparable
			Oat Granola	4/44	2.72	1911	Wheat muffin (C), (0.2/46)	Excluded: > 1 g difference in avCHO & control not comparable
Rieder et al. (2019)	≥ 2 days	14	Barley bread	0.8/26	1.0	376	White wheat bread (0.1/26)	−15.6; ns	−8.5; ns
			Low OBC bread	1.7/26.4	1.93	421		−37.0; s	−14.3; ns
			Degraded OBC bread	3.8/26.2	4.35	282		Excluded: BG dose > 4 g/30 g avCHO
			Optimal OBC bread	3.8/26.2	4.33	592		Excluded: BG dose > 4 g/30 g avCHO
Thondre and Henry (2009)	≥ 1 day	8	Wheat chapati + BG barley concentrates (Barley balance)	2/50	1.2	650–700	Wheat chapati (0/50)	−1.4; ns	NR a
				4/50	2.40			−40; s
				6/50	3.6			−16; ns
				8/50	4.80	650–700	Wheat chapati (0/50)	Excluded: BG dose > 4 g/30 g avCHO
Thondre and Henry (2011)	NR	10	Wheat chapati + BG barley concentrates (glucagel)	4/50	2.40	150	Wheat chapati (0/49.9)	Values NR; ns	NR a
				8/50	4.80	150	Wheat chapati (0/49.9)	Excluded: BG dose > 4 g/30 g avCHO
Wolever et al. (2018)	NR	40	Instant oatmeal + oat bran BG + 2% Milk (240 mL)	1.17/27.6	1.27	NR	Cream of rice +2% Milk (240 mL) (0/27.9)	−5.8; ns	−10.7, s
				1.37/27.7	1.48			−12.5; ns	−12.7; s
				1.57/27.7	1.70			−7.32; ns	−18; s
				1.97/27.9	2.12			−12.7; ns	−28.3; s
				2.77/28.1	2.96			−20.6; s	−40.6; s
Wolever et al. (2019)	≥ 2 days	30	Instant oats + lactose‐ and fat‐free milk (218.5 g)	1.79/30.6	1.75	NR	Cream of rice + lactose‐ and fat‐free milk (218.5 g) (0/30.6)	+5.1; ns	+5.36; ns
			Old‐fashioned oats + lactose‐ and fat‐free milk (218.5 g)	1.72/30.6	1.69			−5.1; ns	−16.1; s
			Steel cut oats + lactose‐ and fat‐free milk (218.5 g)	1.74/30.6	1.71			−30.6; s	−26.1; s
			Honey nut cheerios + lactose‐ and fat‐free milk (218.5 g)	1.05/34.9	0.89	NR	Cream of rice + lactose‐ and fat‐free milk (218.5 g) (0/30.6)	Excluded: > 1 g difference in avCHO
Wolever et al. (2020)	≥ 5 days	28	INST oatmeal + oat bran BG	2/51.2	1.17	1990	Cream of rice (0/51.3)	−23; ns	−21.3; s
			INST oatmeal + oat bran BG	4/51.2	2.34	2060		−42.2; s	−43.7; s
			INST oatmeal + oat bran BG + beta‐glucanase (lower viscosity)	4/51.2	2.34	< 10		−21.5; ns	−21; s
Zhu et al. (2020)	NR	10F	Whole grain oats cooked under normal pressure	3.8/50	2.28	NR	Cooked rice (0/50)	−39.7; s	−34.3; s
			Whole grain oats cooked under high pressure	3.8/50	2.28			−39.3; s	−34.3; s
			Pearled oats cooked under normal pressure	3.1/50	1.86			−38.4; s	−37.1; s
			Pearled oats cooked under high pressure	3.1/50	1.86			−31.9; s	−37.1; s
			Whole grain oats cooked under normal pressure + cooked rice	1.9/50	1.14			−31; ns	−22.9; ns
			Whole grain oats cooked under higher pressure + cooked rice	1.9/50	1.14			−22.9; ns	−11.4; ns
			Pearled oats cooked under normal pressure + cooked rice	1.6/50	0.96			−23.4; ns	−17.1; ns
			Pearled oats cooked under high pressure + cooked rice	1.6/50	0.96			−16.9; ns	−14.3; ns

Abbreviations: avCHO: available carbohydrates; BG: beta‐glucan; CHO: carbohydrates; F: female; GI: glycaemic index; HMW: high molecular weight; INST: instant; iPkG: incremental peak glucose rise; LMW: low molecular weight; M: males; metS: metabolic syndrome; MW: molecular weight; NA: not available; NR: not reported; ns: non‐statistically significant; OBC: oat beta‐glucan concentrate; PW: Prowashonupana wheat; s: statistically significant; WB: wheat bran.

^a Values for incremental peak glucose (or comparison) not reported, but glucose curves are provided.

^b % change was calculated using the incremental peak glucose response. The peak glucose occurred at 30 min for the bread wheat flour, 45% min for the whole grain barley flour, the sieved fraction and the water‐extracted fraction. In the application, the applicant calculated the % change in incremental glucose response at 30 min.

^c No mention of the incremental peak glucose, no glucose curves provided.

^d Only absolute maximum blood glucose concentrations are reported.

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens) , Turck, D. , Bohn, T. , Cámara, M. , Castenmiller, J. , de Henauw, S. , Hirsch‐Ernst, K.‐I. , Jos, A. , Maciuk, A. , Mangelsdorf, I. , McNulty, B. , Naska, A. , Pentieva, K. , Thies, F. , Drenjančević, I. , Craciun, I. , Fiolet, T. , & Siani, A. (2025). Beta‐glucans from oats or barley and reduction of postprandial glycaemic responses: Modification of an authorised health claim pursuant to Article 13(1) of Regulation (EC) No 1924/2006 following a request in accordance with Article 19 of Regulation (EC) No 1924/2006. EFSA Journal, 23(9), e9630. 10.2903/j.efsa.2025.9630