| Study ID | |
| RefID (DistillerSR) | 3810 |
| Reference (authors, year, title, other info) | Bornet, F., Blayo, A., Dauchy, F., & Slama, G. (1996a). Plasma and Urine kinetics of erythritol after oral ingestion by healthy humans. Regulatory Toxicology and Pharmacology, 24(2 Pt 2), 280–285. https://doi.org/10.1006/rtph.1996.0109 |
| Source (published/unpublished) | Published |
| Study design | |
| Study type | HCT |
| Type of blinding | Not blinded |
| Duration of the study and length of follow‐up | 1 day per test material |
| Subjects | |
| Number of participants in the study | Six participants |
| Number of exposed/non‐exposed subjects or number of cases/controls (if applicable) | Six exposed |
| Sex (male/female) | Three males and three females |
| Age (mean or range as reported) | 24–43 years old (mean: 32.67 ± 6.8) |
| Geography (country) | Not reported |
| Ethnicity | Not reported |
| Confounders and other variables as reported | Not reported |
| Special health condition of participants | Healthy |
| Inclusion and exclusion criteria in the study | No subjects were included in the study who had fasting blood sugar levels above 5.5 mmol/L, were pregnant, had diabetes mellitus or were HIV positive |
| Other information | |
| Intervention/exposure | |
| Test material | Erythritol |
| Description of the intervention and estimated dietary exposure | Following an overnight fast, all subjects ingested a single oral dose of 1 g erythritol/kg bw dissolved in 250 mL of water. The total dose administered to each subject ranged from 56 to 78 g, depending on the body weight of the individual |
| Co‐exposure description (if applicable) | Not applicable |
| Endpoint measured, measurement time points and methods |
Fifteen minutes prior to erythritol administration and every 30 min during the period from 0 to 3 h post ingestion, blood samples were collected for analysis of plasma glucose and insulin levels Blood samples also were collected for analysis of plasma erythritol levels every 5 min during the period from 0 to 15 min post ingestion, every 15 min during the period from 15 min to 1 h post ingestion, and every 30 min during the period from 1 to 3 h post ingestion. A blood sample also was taken prior to erythritol ingestion for the determination of plasma creatinine levels At 30 min and 1, 2 and 3 h post ingestion, urine was collected, its volume was measured, and erythritol and creatinine concentrations were determined. Over the next 21 h, total urine output was measured Follow‐up medical examinations were performed 24 h after erythritol administration Urine samples were stored at −20°C for 5 weeks prior to erythritol determinations. Similarly, plasma samples were stored at −20°C for 4 to 5 weeks prior to erythritol and insulin determinations. Plasma glucose determinations were conducted immediately after collection GI symptoms were self‐reported |
| Were sub‐groups analyses predefined? (yes/no, including justification) | Not applicable |
| Results | |
| Findings reported by the study author/s |
Four out of six subjects (three females and one male) described gastrointestinal symptoms at the 24‐h follow‐up examination: two reported diarrhoea, while the others reported abdominal cramping, discomfort and flatulence The data indicate that neither plasma glucose nor plasma insulin was affected by the ingestion of erythritol Blood erythritol levels: increased during the first 30 to 40 min, reaching a maximum value of approximately 2.2. mg/mL after 90 min. Then declined gradually to approximately 1.5–1.7 mg/mL at the end of the 3‐h sampling period Urine erythritol levels: An average of 30% of the ingested amount of erythritol was excreted unchanged in the urine during the first 3 h. Total urinary excretion of ingested erythritol increased to 78% after 24 h The mean erythritol clearance for the six subjects was 62.0 ± 2.8 mL/min. During the same period, creatinine clearance was 120.2 ± 12.3 mL/min |
| Statistical analysis | |
| Statistical methods (including power analyses, multiple comparison, potential sources of bias, adjustment for confounders, test for interactions) | Not reported |
| Further information | |
| Study ID | |
| RefID (DistillerSR) | 3793 |
| Reference (authors, year, title, other info) | Bornet, F., Blayo, A., Dauchy, F., & Slama, G. (1996b). Gastrointestinal response and plasma and urine determination in human subjects given erythritol. Regulatory Toxicology and Pharmacology, 24(2 Pt. 2), 296–302. 10.1006/rtph.1996.0111 |
| Source (published/unpublished) | Published |
| Study design | |
| Study type | HCT |
| Type of blinding | Not reported |
| Duration of the study and length of follow‐up | 1 day per test material |
| Subjects | |
| Number of participants in the study | 24 participants |
| Number of exposed/non‐exposed subjects or number of cases/controls (if applicable) | 24 exposed |
| Sex (male/female) | 12 Males and 12 Females |
| Age (mean or range as reported) |
Range: 20–46 Negative control group (4M/2F): 28.0 ± 8.3 Sucrose group (1M/5F): 33.5 ± 8.2 E4 group (3M/3F): 26.7 ± 7.4 E8 group (4M/2F): 27.3 ± 9.2 |
| Geography (country) | Not reported |
| Ethnicity | Not reported |
| Confounders and other variables as reported | Not reported |
| Special health condition of participants | Healthy |
| Inclusion and exclusion criteria in the study | Subjects were excluded from the study if they were pregnant, had digestive or hepatic abnormalities, or had cardiac or renal abnormalities |
| Other information | |
| Intervention/exposure | |
| Test material | Erythritol |
| Description of the intervention and estimated dietary exposure | The subjects were randomly divided into four groups of six individuals. Three of the groups were administered a snack containing 0.4 g erythritol/kg bw per day (E4 group), 0.8 g erythritol/kg bw per day (E8 group) or 0.8 g sucrose/kg bw per day (sucrose control group). The fourth group no snack (negative control group) |
| Co‐exposure description (if applicable) | Not applicable |
| Endpoint measured, measurement time points and methods |
Plasma glucose levels (expressed in mmol/litre) were measured by a glucose oxidase method (Beckman analyser II). Plasma insulin levels (expressed in mU/litre) were determined using a radioimmunological assay with dextran–charcoal separation (intraassay variability = 6%). Plasma creatinine levels (expressed in μmmol/litre) were measured using a kinetic colorimetric assay (Synchron CX3, Beckman). Plasma sodium, potassium and chloride levels were measured using a Hitachi 717 automated chemistry analyser. Plasma bicarbonates were determined using an enzymatic technique (Biomerieux kit). Albumin was measured using a colorimetric technique with bromocresol green. Urea was measured using an enzymatic technique (Urease, Biomerieux kit). Osmolarity was determined by measuring the freezing point depression Urinary levels of NAG and GGT were measured using a Boehringer kit and a Roche kit, respectively. The plasma erythritol concentration was determined using an HPLC method with 1,3‐butanediol as an internal standard (IS). 1,3‐Butanediol has similar chromatographic properties to erythritol and was added to plasma samples before the deproteinisation step. A 1/100 dilute solution of IS was originally prepared and the area under the HPLC curve measured under the conditions of the assay Plasma samples were centrifuged and analysed in triplicate. One millilitre of the 1/100 dilution of IS was mixed with 3 mL of centrifuged plasma sample before the deproteinisation step. Deproteinisation was performed by mixing, in a centrifuge tube, 3 mL of icecold perchloric acid (0.6 mol/litre) with the IS/plasma sample mixture. After centrifugation, 1 mL of potassium carbonate solution (0.75 mol/litre) was mixed with 3 mL of supernatant and centrifuged after 3 min in an ice bath. The supernatant was immediately frozen at −20°C for HPLC analysis at a later time. After thawing, the samples were centrifugated and the supernatant was decanted and put into HPLC vials. Erythritol was measured by means of HPLC using a Waters HPLC Solvent Delivery System M45 with a Waters HPLC Differential Refractive Index Detector R401 (Millipore Corp., Milford, MA). A Shodex Ionpack Column KC811 with an internal diameter of 8 mm and a length of 300 mm was used. The injected sample volume was 5 μL. The column operating temperature was 75°C and the flow rate was 1 mL/min. HPLC‐grade water containing 0.0018 H2SO4 was used as the eluent Sample preparation and HPLC processing were designed to avoid manipulation errors, such as adding the IS before the deproteinisation step. Based on the original amount of IS added, the recovery of the IS in the final sample was calculated. Also, the percentage recovery was applied to the analytically determined erythritol levels to compensate for manipulation errors A dilution factor of 2.60 was used to account for dilution of samples which occurred during plasma separation and protein precipitation. Results were expressed as erythritol concentration (g/litre) After thawing, urine samples were rehomogenised and filtered through a 0.45 μm filter. Samples of 0.5 mL were mixed with 0.25 mL of the IS before being placed in HPLC vials. The HPLC method was the same as described for the plasma erythritol determinations Urine erythritol concentration was expressed as g/litre and erythritol output as g/min Satiety was evaluated before each meal using an arbitrary scale upon which the subjects recorded their sensation of hunger, ranging from no hunger (0) to extreme hunger (100) The presence of digestive complaints was evaluated on the day following the test using a questionnaire similar to that used by Briet et al. (1995). Items on the questionnaire included abdominal pain, nausea, rumblings, bloating, flatulence, decrease in defecation, increase in defecation, soft faeces and hard faeces. Each item was graded by the subject on a scale of 0 (no effect) to 3 (severe effect) |
| Were sub‐groups analyses predefined? (yes/no, including justification) | Not applicable |
| Results | |
| Findings reported by the study author/s |
Ingestion of erythritol did not affect voluntary intake of water. The mean cumulative water consumptions for the negative control, sucrose, E4 and E8 groups were 1.20 ± 0.37, 1.13 ± 0.15, 1.21 ± 0.33 and 1.11 ± 0.32 litres, respectively There was no difference in the perception of hunger among the subjects receiving snacks containing erythritol and those receiving the snack containing sucrose The only significant difference (p < 0.005) in hunger perception was among groups receiving a snack and those which did not receive a snack (negative control group). Although gastrointestinal effects were reported more frequently in subjects in the E4 and E8 groups than in the subjects in the negative control or sucrose groups, these differences were not statistically significant Plasma glucose levels remained normal in all the test groups throughout the study period. Plasma insulin levels remained stable in the two erythritol groups but were significantly increased in the sucrose control group at 1 and 2 h following ingestion of the chocolate snack. Plasma erythritol levels were proportional to the amount of erythritol consumed. As expected, the plasma erythritol levels were higher in the E8 group (P < 0.06) than in the E4 group from 2 h following ingestion to the end of the study. No significant variations in plasma osmolarity were observed among any of the test groups throughout the study period. Plasma calcium concentration also did not vary significantly among the test groups Urine volume was not significantly different among the groups with the exception of the sucrose control group which showed a statistically significant increase during the period from 8 to 22 h following snack ingestion when compared to that of the negative controls or E8 groups Urine erythritol levels in the E8 group was approximately twice that of the E4 group (p < 0.0001). Over the entire study period (22 h following the ingestion), 61 and 62% of the ingested amount of erythritol were excreted in the urine in the E4 and E8 groups |
| Statistical analysis | |
| Statistical methods (including power analyses, multiple comparison, potential sources of bias, adjustment for confounders, test for interactions) | Analytical results were analysed by a variance analysis and the differences between test groups were analysed by nonpaired test using ANOVA (Macintosh Stat view). For the analysis of urinary electrolytes and NAG, if any treatment group‐related effects were found to be statistically significant, pairwise comparisons of interest among the treatment groups were performed using the least significant difference. The NAG data were first log‐transformed. The results from the questionnaire were analysed by the non‐parametric Kruskall–Wallis test |
| Further information | |
| Study ID | |
| RefID (DistillerSR) | 4299 |
| Reference (authors, year, title, other info) | Yokohama‐shi Seibu Hospital, St. Marianna University School of Medicine, Department of Metabolic Endocrinology and Department of Nutrition (1993). The effect of continuous administration of the sweetener erythritol on diabetes patients |
| Source (published/unpublished) | Unpublished |
| Study design | |
| Study type | HCT – Not randomised |
| Type of blinding | Not reported |
| Duration of the study and length of follow‐up | 2 weeks |
| Subjects | |
| Number of participants in the study | 11 participants |
| Number of exposed/non‐exposed subjects or number of cases/controls (if applicable) | 11 exposed |
| Sex (male/female) | Three Males and eight Females |
| Age (mean or range as reported) |
M: 65 ± 6 F: 50 ± 14 Mean age: 54 ± 14 |
| Geography (country) | Japan |
| Ethnicity | Not reported |
| Confounders and other variables as reported | Not reported |
| Special health condition of participants | Outpatients with non‐insulin‐dependent type 2 diabetes mellitus |
| Inclusion and exclusion criteria in the study | Not reported |
| Other information | |
| Intervention/exposure | |
| Test material | Erythritol |
| Description of the intervention and estimated dietary exposure | The Erythritol dosage was set at 20 g/day, and after 1 week of outpatient treatment the subjects used erythritol in drinks and foods daily for 14 days. Blood samples were taken before and after administration during hospital visits. The subjects listed the contents of their food for 3 days before the administration and for 3 days before completing administration on case record forms. The ingested energy and the nutritional amount were computed on the basis of these case record forms |
| Co‐exposure description (if applicable) | Not applicable |
| Endpoint measured, measurement time points and methods | Body weight, fasting blood sugar (FBS) and HbA1c were measured as indices of diabetes control, and BUN, creatinine, beta2‐microglobulin and urinary proteins as indices of renal function |
| Were sub‐groups analyses predefined? (yes/no, including justification) | Not applicable |
| Results | |
| Findings reported by the study author/s |
Interviews at the outpatient examination following the 2‐week erythritol ingestion on the physical condition during the ingestion period revealed no cases of diarrhoea and no specific subjective symptoms In the 3‐ day food surveys before and at completion of administration, no significant postdosing changes were noted in ingested energy, proteins, fats and carbohydrates as well as other nutrients Body weight tended to drop from a pre‐dosing mean of 60.8 ± 11.6 kg to a postdosing mean of 58.1 ± 9.5 kg, but the difference was not significant. FBS tended to decrease from a pre‐dosing mean of 181 ± 60 mg/dL to a postdosing mean of 165 ± 57 mg/dL. The decrease was especially pronounced in patients with high pre‐dosing levels. HbA1c showed a significant drop from a pre‐dosing mean of 8.5 ± 1.5% to a postdosing mean of 7.5 ± 1.6% (p < 0.05). Two‐ week administration of erythritol thus had no negative effect on body weight or blood glucose control BUN, an index of renal function, showed no large postdosing changes, either in patient whose pre‐dosing levels were higher than the normal levels of 21 mg/dL or in patients with normal levels, and the pre‐dosing mean of 15.3 ± 5.0 mg/dL hardly differed from the postdosing mean of 14.0 ± 7.3 mg/dL. None of the patients showed an abrupt postdosing rise in blood creatinine levels, with the postdosing mean of 0.8 ± 0.2 mg/dL virtually unchanged from the pre‐dosing mean of 0.9 ± 0.2 mg/dL Patient with higher pre‐dosing levels than the normal 1.9 mg/L for Beta2‐MG, another index of renal function, tended to show a postdosing drop, but there were no cases of a significant rise Likewise, there were no postdosing changes in urinary proteins. The indices of renal function in diabetes patients thus showed no large changes even after 2‐week administration of 20 g of erythritol |
| Statistical analysis | |
| Statistical methods (including power analyses, multiple comparison, potential sources of bias, adjustment for confounders, test for interactions) | Not reported |
| Further information | |
| Study ID | |
| RefID (DistillerSR) | 5111 |
| Reference (authors, year, title, other info) | Teysseire, F., Bordier, V., Budzinska, A., Van Oudenhove, L., Weltens, N., Beglinger, C., Wölnerhanssen, B. K., & Meyer‐Gerspach, A. C. (2023). Metabolic effects and safety aspects of acute D‐allulose and erythritol administration in healthy subjects. Nutrients, 15(2), 1228–1238. https://doi.org/10.1093/jn/nxac026 |
| Source (published/unpublished) | Published |
| Study design | |
| Study type | HCT – Cross‐over trial – Randomised – Placebo‐controlled |
| Type of blinding | Double‐blinded |
| Duration of the study and length of follow‐up | 1 day per test material |
| Subjects | |
| Number of participants in the study | 21 participants |
| Number of exposed/non‐exposed subjects or number of cases/controls (if applicable) | 18 exposed |
| Sex (male/female) | 5 Males and 13 Females |
| Age (mean or range as reported) | 19–35 |
| Geography (country) | Switzerland |
| Ethnicity | Not reported |
| Confounders and other variables as reported | Not reported |
| Special health condition of participants | Healthy |
| Inclusion and exclusion criteria in the study | Subjects were eligible for the study when meeting all of the subsequent inclusion criteria: age between 18 and 55 years, BMI of 19.0–24.9 kg/m2 and normal eating habits (no diets, no dietary changes). Exclusion criteria were medical or drug abuse including alcohol dependence, acute or chronic infection or illness, illnesses affecting the GI tract, pre‐existing consumption of D‐allulose and/or erythritol more than once a week, pregnancy and involvement in another study with an investigational drug within 30 days preceding and/or during the study |
| Other information | |
| Intervention/exposure | |
| Test material | Erythritol |
| Description of the intervention and estimated dietary exposure | Each subject took part in three separate study visits as follows: 25 g d‐allulose, 50 g erythritol or 300 mL tap water (placebo). The solutions were dissolved in 300 mL tap water. The order of the study visits was randomised and counterbalanced among subjects. The study visits took place at least 3 days apart and after a 10 h overnight fast. All study visits started at 08:30 in the morning and, upon arrival, a cannula was inserted into a forearm vein for blood collection. Next, a nasogastric feeding tube (external diameter of 8 French) was inserted into the stomach |
| Co‐exposure description (if applicable) | Not applicable |
| Endpoint measured, measurement time points and methods |
After taking blood samples in a fasting state (t = −10 and − 1 min), subjects received one of the solutions (at t = 0 min) via the nasogastric feeding tube over 2 min. More blood samples were taken at t = 15, 30, 45, 60, 90, 120 and 180 min for the analysis of glucose, insulin and ghrelin, and at t = 30, 60 and 120 min, for analysis of blood lipids, uric acid and hsCRP. Blood pressure and heart rate were measured at the beginning and at the end of each study visit |
| Were sub‐groups analyses predefined? (yes/no, including justification) | Not applicable |
| Results | |
| Findings reported by the study author/s | Glucose and insulin concentrations were lower after D‐allulose compared to tap water (p = 0.001, dz = 0.91 and p = 0.005, dz = 0.58, respectively); however, Bayesian models show no difference for insulin in response to d‐allulose compared to tap water, and there was no effect after erythritol. An exploratory analysis showed that ghrelin concentrations were reduced after erythritol compared to tap water (p = 0.026, dz = 0.59), with no effect after d‐allulose; in addition, both sweeteners had no effect on blood lipids, uric acid and hsCRP |
| Statistical analysis | |
| Statistical methods (including power analyses, multiple comparison, potential sources of bias, adjustment for confounders, test for interactions) |
For the metabolic effects (glucose, insulin and ghrelin) and safety aspects (blood lipids, uric acid and hsCRP) parameters, no sample size calculations were performed. However, in a sensitivity power calculation, the sample size of 18 participants yields 80% power to detect a medium effect size (Cohen's d = 0.65) for the comparison of d‐allulose and erythritol with tap water using a one‐tailed paired t‐test with Holm multiple testing correction (α = 0.0375). The one‐tailed test is justified by the directional nature of our hypothesis regarding the effects on ghrelin. Data is presented as the mean ± SEM unless otherwise stated. A two‐tailed p‐value < 0.05 was considered significant and Cohen's dz for paired t‐tests was presented for effect sizes. Kolmogorov–Smirnov testing and quantile plots were used to assess normality; for instance, if necessary, natural logarithmic transformations of the data were used to normalise distributions. The visit number was included to control for putative order effects in all models. The metabolic and safety outcome variables were analysed using linear mixed models on changes from baseline (average of pre‐infusion time point(s) for the metabolic parameters) and absolute values for the safety aspect parameters. ‘Solution’ and ‘time’ were included as within‐subject independent variables in the models (including their main effects and the interaction). The metabolic outcome models controlled for baseline values. To follow‐up on significant main or interaction effects, planned contrast analyses were performed to test the specific hypotheses, with stepdown Bonferroni (Holm) correction for multiple testing To test the hypotheses that glucose and insulin concentrations, in response to d‐allulose and erythritol, will be similar to tap water and that ghrelin will be reduced in response to d‐allulose and erythritol compared to tap water, respectively, were compared the post‐infusion glucose, insulin and ghrelin concentration changes from the baseline between tap water and d‐allulose or erythritol. Was not formulate any a priori hypotheses about the safety outcomes. Given the hypothesis about glucose and insulin concentrations being similar for the two solutions compared to tap water, was complemented the frequentist statistical analysis with Bayesian analyses |
| Further information | |
| 21 subjects were randomised. There were three drop‐outs (one subject withdrew due to knee surgery and two withdrew for personal reasons). A total of 18 subjects completed the three study visits. Complete data sets from all 18 subjects were available for analysis | |
| Study ID | |
| RefID (DistillerSR) | 3756 |
| Reference (authors, year, title, other info) | Overduin, J., Collet, T.‐H., Medic, N., Henning, E., Keogh, J. M., Forsyth, F., Stephenson, C., Kanning, M. W., Ruijschop, R. M. A. J., Farooqi, I. S. and van der Klaauw, A. A. (2016). Failure of sucrose replacement with the non‐nutritive sweetener Erythritol to alter GLP‐1 or PYY release or test meal size in lean or obese people. Appetite, 107, 596–603. https://doi.org/10.1016/j.appet.2016.09.009 |
| Source (published/unpublished) | Published |
| Study design | |
| Study type | HCT ‐ single centre, randomised, cross‐over study |
| Type of blinding | Single‐blinded (though one test meal had a larger volume) |
| Duration of the study and length of follow‐up | 1 day per test material |
| Subjects | |
| Number of participants in the study | 20 participants |
| Number of exposed/non‐exposed subjects or number of cases/controls (if applicable) | 20 exposed |
| Sex (male/female) | 10 males and 10 females |
| Age (mean or range as reported) |
Lean group: 33.4 (26.3–47.0) years old Obese group: 34.6 (24.9–46.7) years old |
| Geography (country) | UK |
| Ethnicity | Not reported |
| Confounders and other variables as reported | Not reported |
| Special health condition of participants | 10 lean (BMI < 25 kg/m2) and 10 obese (BMI > 30 kg/m2) |
| Inclusion and exclusion criteria in the study | Exclusion criteria: administering any medication, presence of any medical illnesses including diabetes, lactose intolerance or any food allergies |
| Other information | |
| Intervention/exposure | |
| Test material | Erythritol (Zerose™ Erythritol, Cargill, Vilvoorde, Belgium) |
| Description of the intervention and estimated dietary exposure |
On three occasions separated by ≥ 1 week, subjects fasted from 22:00 h the night before each study day and were then admitted to the test centre the following morning to consume one of the following: (a) the sucrose control meal, (b) an isovolumic (reduced calorie) serving of the erythritol meal, (c) an isocaloric (larger volume) serving of the erythritol meal to match for calories to the control meal The breakfast test meals were semi‐solid custard (NIZO Food Research B.V. (Ede, The Netherlands) allowing the manipulation of sucrose/erythritol content and the required volume for each volunteer. The calorie content of the sucrose control meal was standardised for each participant to match 20% of the individually calculated energy requirements, based on Schofield a equations for basal metabolic rate, multiplied by a physical activity index of 1.25 The sucrose control meal contained 10 g of sucrose per 100 g of meal (10% w/w) and the erythritol meal contained 8% (w/w) erythritol and 2% (w/w) sucrose and had a 25% lower energy density than the sucrose meal. Care was taken to match the sweetness of the erythritol and sucrose control meals: as erythritol provides approximately 0.7× the sweetness of sucrose, 0.004 g sucralose per 100 g of the erythritol food was added |
| Co‐exposure description (if applicable) | Erythritol and sucrose (8% and 2% w/w, respectively) |
| Endpoint measured, measurement time points and methods |
Gut hormone (GLP‐1 and PYY) levels, hunger and satiety scores, ad libitum food intake, sucrose preference and intake after the manipulations For GLP‐1 and PYY: an intravenous cannula was inserted, and volunteers rested for 30 min. Blood was drawn and VAS scores completed to assess hunger and fullness half‐hourly from 07:30 h until 12:00 h. The first two measurements were averaged as the baseline before breakfast. Test breakfasts were given at 08:00 h and consumed within 20 min. VAS were measured on a 10 cm line for liking of the meal and sweet and savoury sensations to assess potential within‐meal and between‐meal sensory differences after a mouthful and after completion of the test breakfast. The sucrose control and erythritol test meals were rated as equally palatable and as equally sweet An ad libitum buffet lunch was served at 12:30 h, consisting of 3 common food items (chicken korma, sweet and sour chicken, orange cake). There were two versions of each item designed to provide low sucrose and high sucrose content; meals were covertly weighed before and after consumption: all were presented to participants at the same time and they were instructed to select items at will and eat until comfortably full (in individual rooms). Consumption of each food item was then covertly weighed Blood was collected in EDTA tubes containing 100 mL aprotinin (for PYY and total GLP‐1), lithium heparin tubes (for insulin) and fluoride oxalate tubes (for glucose). Plasma samples were centrifuged immediately at 4°C and stored at −80°C until assays were performed. Plasma glucose was assayed on the same day using the glucose oxidase method. Insulin was quantified using a commercially available immunoassay (AutoDELFIA Insulin Kit; PerkinElmer, Wellesley, MA, USA). Plasma PYY and total GLP‐1 were measured by an established in‐house radioimmunoassay b , c |
| Were sub‐groups analyses predefined? (yes/no, including justification) | Not applicable |
| Results | |
| Findings reported by the study author/s |
There was a greater difference in postprandial glucose and insulin levels after the sucrose meals, rather than the erythritol meals. There were no differences in GLP‐1 or PYY levels or subsequent energy intake and sucrose preference between sucrose control and isovolumic erythritol meals. In lean (but not obese) participants, hunger decreased to a greater extent after the isocaloric erythritol meal compared to the control meal (p = 0.003) due to the larger volume of the erythritol meal. Comparable hunger and satiety scores, GLP‐1 and PYY levels, and subsequent sucrose preference and intake were recorded when sucrose was replaced with erythritol Limitations of the study included: potential changes in the rate of gastric emptying were not assessed, the study assessed the AUC of GLP‐1 and PYY levels and therefore transient changes in blood levels may have been missed, the study had limited power to assess small changes in VAS scores, and the effects of an erythritol‐pure meal were not tested |
| Statistical analysis | |
| Statistical methods (including power analyses, multiple comparison, potential sources of bias, adjustment for confounders, test for interactions) |
Data were analysed using Stata software package (v. 12.1, StataCorp, College Station, TX, USA). The AUC was calculated for the VAS, glucose, insulin and the gut hormones between the three breakfasts. Peak values between the three breakfasts were also compared for glucose and insulin: lean and obese participants were first analysed separately by ANOVA with repeated measures to test for within‐subjects changes and between breakfast differences. Multivariate ANOVA with repeated measures was then performed to investigate group differences between lean and obese volunteers with test meal as within‐subjects factor and group as between subjects' factor. The within‐subjects p‐value was adjusted using the Greenhouse–Geisser correction factor (ε) for lack of sphericity. Pairwise comparisons of the study phases were performed by two‐sided Student's t‐test when appropriate. p = 0.05 was considered significant after Bonferroni correction for multiple comparisons Sample size was based on effect differences from previous studies. Post hoc power analysis of repeated measures ANOVA in a crossover study with this sample size showed power ranged 74% – 99.8% for hormone AUC comparisons (except for PYY AUC in obese participants: 33%) |
| Further information | |
Schofield, W. N. (1985). Predicting basal metabolic rate, new standards and review of previous work. Human Nutrition Clinical Nutrition, 39(Suppl. 1), 5–41.
Adrian, T. E., Ferri, G. L., Bacarese‐Hamilton, A. J., Fuessl, H. S., Polak, J. M., & Bloom, S. R. (1985). Human Distribution and Release of a Putative New Gut Hormone, Peptide YY. Gastroenterology, 89(5), 1070–1077.
Kreymann, B., Williams, G., Ghatei, M. A., & Bloom, S. R. (1987). Glucagon‐like peptide‐1 7–36: a physiological incretin in man. Lancet, 2(8571), 1300–1304.