Abstract
Aims
To evaluate changes in dietary intake following liraglutide treatment, compared to dietitian‐supported caloric restriction and a weight‐neutral control, and to assess dietary intake against nutrition recommendations.
Materials and Methods
Participants with obesity and prediabetes were randomly assigned 2:1:1 to liraglutide (1.8 mg/day), dietitian‐supported caloric restriction (−390 kcals/day) or dipeptidyl peptidase‐4 inhibitor (100 mg/day) for 14 weeks. Dietary intake was assessed via a single 24‐h dietary recall pre‐ and postintervention. Within‐group changes and between‐group differences in macronutrient and micronutrient intake, diet quality and food sources were evaluated, and the proportion of participants meeting nutrition recommendations was calculated.
Results
Seventy participants (69% female, 83% white) were included. Average age was 49.4 ± 11.3 years, and mean BMI was 39.5 ± 6.1 kg/m2. Significant differences in change in percent calories from protein (p = 0.037), carbohydrates (p = 0.019) and added sugar (p = 0.002) were observed across groups, with those in the caloric restriction group having the greatest increase in protein and decreases in carbohydrates and added sugar. Micronutrient intake did not significantly differ between groups nor did Total Healthy Eating Index (HEI)‐2020 scores. However, the caloric restriction group significantly improved their HEI component score for added sugar compared to the liraglutide group (p = 0.002) when adjusted for baseline intake. Despite the treatment group, participants failed to meet several of the same nutrition recommendations, including those for fruit, vegetable and dairy intake.
Conclusions
Overall diet quality was poor across all groups. However, the caloric restriction group significantly reduced its added sugar intake, highlighting a potential benefit nutrition counselling may have for AOM users. Future research is needed to examine the long‐term impact of AOM use on dietary intake, with and without nutrition guidance, to better inform clinical recommendations.
Keywords: antiobesity drug, clinical trial, dietary intervention, liraglutide, obesity therapy, weight management
1. INTRODUCTION
Obesity and prediabetes are serious public health concerns in the United States, affecting 40.3% and 38.0% of U.S. adults, respectively. 1 , 2 These conditions significantly increase the risk for developing type 2 diabetes and cardiovascular disease, 3 two leading causes of death in the United States. 4 Fortunately, both obesity and prediabetes, along with their associated comorbidities, can be reversed through effective weight management strategies. Recent advances in weight management practices have been made, including the U.S. Food and Drug Administration approval of several anti‐obesity medications (AOMs) for chronic weight management, including Saxenda (liraglutide), 5 Wegovy (semaglutide) 6 and Zepbound (tirzepatide). 7 AOMs support weight loss through a variety of mechanisms, including a reduction in hunger, appetite and ‘food noise’ (i.e., constant food‐related thoughts), 8 and an increase in satiety—all of which promote reduced energy intake. 9 As a result, these medications are highly effective for weight management, 10 , 11 reducing body weight by ≥15% over 1 year. 12 Beyond weight loss, these medications have been shown to reduce the risk of obesity‐related comorbidities, demonstrating a 94% risk reduction in type 2 diabetes, 13 a 39% risk reduction in obesity‐related cancers 14 and a 20% risk reduction in major cardiovascular events compared to a placebo. 15 While these medications are valuable in addressing the physiological aspects of obesity, they are still intended to be used in combination with diet and physical activity interventions to optimize outcomes.
Positive dietary changes offer several health benefits for AOM users that are independent of weight loss, including the prevention of nutrient deficiencies, maintenance of lean body mass and mitigation of AOM‐related side effects. 12 Furthermore, achieving macro‐ and micronutrient recommendations while maintaining adequate diet quality can offer further benefits, such as chronic disease prevention. 16 To date, however, there are no clinical practice guidelines established that provide nutrition recommendations specifically for AOM users. 12 , 17 Suggested dietary recommendations for AOM users vary widely from those that target the general population, to bariatric surgery patients, to people following very low‐calorie diets or from what is observed in clinical practice. 12 , 18 For example, Almandoz and colleagues recommended between 1200 and 1500 kcals/day for women and 1500 and 1800 kcals/day for men using AOMs, along with a minimum of 2–3 L/day of fluids and 21–25 g/day of fibre for women and 30–38 g/day of fibre for men to prevent AOM‐related constipation. 18 Similar to other weight loss regimens, they also recommend optimizing micronutrient intake and increasing protein intake to 1.5 g/kg/day to prevent loss of lean body mass, which is substantially greater than the 0.8 g/kg/day recommended by the 2020–2025 Dietary Guidelines for Americans. 16 , 18 Other dietary recommendations have been made to mitigate common AOM‐related gastrointestinal side effects, including the avoidance of greasy, fried or high‐sugar foods, and the alteration of eating patterns to consume smaller, more frequent meals, and to avoid late‐night eating. 12 Despite these recommendations, there remains a lack of evidence regarding the current dietary intake of AOM users, which is crucial to determining whether tailored dietary guidelines are needed for this population, and if so, what practical clinical recommendations should be made.
A recent literature review of 10 studies aimed to characterize dietary intake after AOM initiation. 19 Most studies measured ad libitum intake after a standardized meal, and only one study used validated 24‐h diet recalls to assess real‐world dietary changes after AOM initiation. 20 All studies assessed changes in energy intake, which were reduced by 16%–39% in the AOM group versus a placebo control. While four studies evaluated macronutrient intake, their findings varied, and no studies examined changes in micronutrient intake, eating patterns or diet quality. 19 In an effort to understand whether tailored dietary guidelines are needed for AOM users, it is essential to examine the changes they make to their dietary patterns and nutrient intake without behavioural guidance and determine how they align with current nutrition recommendations. To begin to fill this research gap, this secondary analysis used 24‐h diet recall data from a previously published three‐arm randomized controlled trial 20 to analyse changes in macro‐ and micronutrient intake, diet quality and eating patterns among new AOM users who were not receiving diet counselling, compared to a Registered Dietitian‐supported caloric restriction group and a weight‐neutral placebo control group.
2. MATERIALS AND METHODS
2.1. Study design
This is a secondary analysis of a 20‐week (6‐week run‐in, 14‐week treatment), three‐arm, randomized controlled trial that examined the effect of the glucagon‐like peptide‐1 (GLP‐1) receptor agonist (liraglutide), compared to Registered Dietitian‐supported caloric restriction or a weight‐neutral placebo control group (sitagliptin, a dipeptidyl peptidase‐4 inhibitor that enhances GLP‐1 activity without promoting weight loss), 21 on appetite, dietary intake, body fat distribution and cardiometabolic biomarkers in adults with obesity and prediabetes. Treatment with liraglutide and sitagliptin was double‐blinded and placebo‐controlled.
The study, described in full elsewhere, 20 , 22 was conducted in accordance with the Declaration of Helsinki, registered at clinicaltrials.gov (NCT03101930) and approved by the Vanderbilt University Medical Center Institutional Review Board (IRB#170213). Prerandomization, participants underwent a 6‐week run‐in phase for the medical management of hypertension and dyslipidaemia, as required for the study's primary outcome of vascular function. 22 Participants then completed baseline assessments and were randomized 2:1:1 to receive liraglutide (1.8 mg/day), sitagliptin (100 mg/day) or caloric restriction (−390 kcal/day) for 14 weeks.
Participants assigned liraglutide received prefilled FlexPens and an oral placebo (Novo Nordisk, Bagsvaerd, Denmark), while participants assigned sitagliptin received FlexPen placebos and oral medication (Merck & Co., Inc., U.S.). Dose escalation was utilized for the administration of liraglutide, beginning at 0.6 mg/day during Week 1, 1.2 mg/day during Week 2 and 1.8 mg/day starting Week 3. Aside from the medication itself, all study procedures were identical between the liraglutide and sitagliptin groups. The liraglutide and sitagliptin groups received no dietitian support.
Those randomized to the caloric restriction group were provided with a personalized caloric goal of approximately 390 kcal/day below their resting energy expenditure (assessed via indirect calorimetry). This caloric deficit was based on previous literature, with the goal of eliciting similar weight loss to those randomized to liraglutide at a dose of 1.8 mg/day (approximately −0.27 kg/week). 23 , 24 , 25 , 26 These participants attended an initial counselling session with a study‐designated Registered Dietitian, who offered personalized guidance (based on the participant's medical history and baseline 24‐h dietary recalls) on strategies to reduce caloric intake and achieve their prescribed calorie goals. 20 , 22 Tips on how to reduce caloric intake included controlling portion sizes, avoiding energy‐dense foods (e.g., regular soda, fried foods, high‐sugar candy and desserts), choosing nutrient‐dense foods (e.g., fruits, vegetables and whole grains), consuming noncaloric beverages (e.g., diet soda and unsweetened tea) and cooking with zero‐calorie or low‐calorie ingredients (e.g., lemon juice, herbs and sugar‐free jam). Participants were also provided with sample meal plans based on their calculated caloric goal. At the end of the initial session, participants developed written diet and activity goals in the form of a contract. They were then directed to track their intake and calories using a paper food diary for the remainder of the intervention. Participants in the caloric restriction group continued to meet with the Registered Dietitian bi‐weekly, on an individual basis to confirm compliance with the prescribed intervention. These sessions typically lasted 30–60 min and were held at the Vanderbilt University Diet, Body Composition and Human Metabolism Core. The bi‐weekly sessions included personalized counselling, related to weight loss, based on the participant's current intake (via food diaries), caloric goal and food preferences and tolerances. Similar to the initial counselling session, a strong emphasis was placed on increasing nutrient‐rich foods and limiting energy‐dense foods during these sessions.
2.2. Participants
Participants of the parent study were recruited through the Vanderbilt Clinical Research Center from May 2017 to June 2021. Eligible participants were men and women between the ages of 18 and 65, with a BMI ≥30 kg/m2 and prediabetes. Prediabetes was defined by the American Diabetes Association as having a fasting glucose level between 100 and 125 mg/dL, an oral glucose tolerance test 2‐h blood glucose level between 140 and 199 mg/dL or a glycated haemoglobin level of 5.7%–6.4%. 27 People were ineligible if they were pregnant or lactating, had type 1 or type 2 diabetes, significant cardiovascular disease, resistant hypertension, impaired kidney or liver function, a history of pancreatitis or regularly used an inhaler for asthma. Additional recruitment details have been described elsewhere. 22 A total of 70 participants with available dietary data at baseline and postintervention were included in this secondary analysis.
2.3. Dietary intake
Dietary intake data were collected by means of dietitian‐administered 24‐h dietary recalls at Vanderbilt University's Diet, Body Composition and Human Metabolism Core at baseline (Week 0) and at the end of treatment (Week 14). The U.S. Department of Agriculture's five‐step multiple‐pass method was used, 28 along with a structured script and measuring utensils to help ensure portion size estimation accuracy. Dietary data were entered into the Nutrition Database System for Research software (NDS‐R; version 2018, Nutrition Coordinating Center, Minneapolis, Minnesota). 29 , 30 , 31 One 24‐h dietary recall per participant was available at baseline and postintervention. Data cleaning was performed prior to computing statistical analyses, which included identifying participants with available dietary data at baseline and postintervention, and excluding outliers based on caloric intake. Data from one participant in the liraglutide group were excluded from further analysis for implausible energy intake at the postintervention time point (caloric intake >4500 kcals), which deviated substantially from their baseline intake of 2442 kcals.
For the current study, usual dietary intake of the groups was described in three ways: total dietary intake, diet quality and dietary patterns. Usual dietary intakes estimated by 24‐h dietary recalls were compared to dietary recommendations. The proportion of participants meeting the nutrient intake recommendations on a given day was computed using the Estimated Average Requirement (EAR) cutpoint method. 32 In accordance with this method, the prevalence of adequate intake was estimated by computing the proportion of participants in each group with intakes above the Food and Nutrition Board of the National Academies of Sciences Engineering's EARs based on age and sex. 32 , 33 When EARs were unavailable, Adequate Intake (AI), Acceptable Macronutrient Distribution Range (AMDR) or 2020–2025 Dietary Guidelines for Americans recommendations were used. While a single 24‐h dietary recall is recommended to describe the proportion of participants meeting a threshold on a given day, it is not recommended for determining between‐group differences in the proportion of participants meeting a threshold. 34 Thus, while this information is presented descriptively, statistical analyses to compare the proportions among groups were not performed.
Diet quality was assessed using the Healthy Eating Index (HEI)‐2020—a scoring metric used to calculate overall diet quality and component scores. 35 Higher scores more closely align with the recommendations of the 2020–2025 Dietary Guidelines for Americans to either consume an adequate amount of, or limit, certain food components. HEI‐2020 guidelines and publicly available code were used to calculate scores.
A posteriori dietary patterns were not statistically derived given the limited sample size of each group. 36 , 37 Alternatively, the top three foods consumed from each food group, ranked by the average quantity (e.g., cups, ounces and grams) consumed per participant per day, were reported. Dietary patterns were derived from the foods reported during the 24‐h dietary recalls at the baseline and postintervention time points and compared.
2.4. Statistical analysis
Descriptive statistics (means, standard deviations and percentages) were computed to describe participant characteristics and dietary intake. Adjustments for energy intake were made by standardizing macronutrients as percentages of total caloric intake, and fibre and micronutrient intake as quantities per 1000 kcals where noted. Normality of the data was assessed using Shapiro–Wilk tests. Within‐group changes in dietary intake were evaluated using paired t tests whether the data were normally distributed or Wilcoxon signed‐rank tests for nonnormally distributed data. Unadjusted between‐group comparisons were assessed using group‐by‐time ANOVAs. Between‐group comparisons were also performed by ANCOVAs that were adjusted for baseline intake. p‐values of <0.05 were considered statistically significant. Post hoc analyses using pairwise comparisons were performed for significant results to identify which of the three groups differed significantly and the direction of change. Post hoc power analyses indicated that for the ANCOVAs, we had 80% power to detect a large effect size (ηp2 = 0.14). Similarly, for the group‐by‐time ANOVAs, we had 80% power to detect a small‐to‐medium effect size (ηp2 = 0.035), assuming the correlation among the repeated measures was conservatively 0.5. All analyses were computed using R software version 4.4.2 (R Foundation for Statistical Computing, Vienna, Austria). 38
3. RESULTS
3.1. Study participants
Baseline characteristics by treatment group are presented in Table 1. A majority of participants were female (n = 48/70, 68.6%), white (n = 58/70, 82.9%) and non‐Hispanic or Latino (n = 66/70, 94.3%). Their average age was 49.4 ± 11.3 years, with a mean BMI of 39.5 ± 6.1 kg/m2.
TABLE 1.
Participant characteristics (N = 70).
| Treatment arms | Overall | |||
|---|---|---|---|---|
| Liraglutide | Caloric restriction | Sitagliptin (control) | ||
| (N = 35) | (N = 16) | (N = 19) | (N = 70) | |
| Age (mean, SD) | 49.3 (10.6) | 46.9 (14.0) | 51.5 (10.4) | 49.4 (11.3) |
| Female (n, %) | 26 (74.3%) | 10 (62.5%) | 12 (63.2%) | 48 (68.6%) |
| Race (n, %) | ||||
| Asian | 1 (2.9%) | 0 (0%) | 0 (0%) | 1 (1.4%) |
| Black or African American | 4 (11.4%) | 4 (25.0%) | 1 (5.3%) | 9 (12.9%) |
| White | 30 (85.7%) | 11 (68.8%) | 17 (89.5%) | 58 (82.9%) |
| More than one race | 0 (0%) | 1 (6.3%) | 1 (5.3%) | 2 (2.9%) |
| Ethnicity (n, %) a | ||||
| Hispanic or Latino | 1 (2.9%) | 0 (0%) | 2 (10.5%) | 3 (4.3%) |
| Not Hispanic or Latino | 33 (94.3%) | 16 (100%) | 17 (89.5%) | 66 (94.3%) |
| Weight (kg) (mean, SD) | 108 (22.2) | 114 (18.6) | 114 (21.5) | 111 (21.1) |
| BMI (kg/m2) (mean, SD) | 39.2 (6.5) | 38.8 (6.1) | 40.4 (5.7) | 39.5 (6.1) |
1 missing value.
3.2. Macro‐ and micronutrient intake
Within‐group changes and between‐group differences in macronutrient intake are presented in Table 2. There were statistically significant between‐group differences in the change in percent of calories from carbohydrates, protein and added sugars among the three treatment groups after adjusting for baseline intake. Post hoc analyses showed that the percent of total calories from carbohydrates decreased more in the caloric restriction group compared to the liraglutide and sitagliptin groups. The caloric restriction group significantly reduced their percent of total caloric intake from added sugar more than the liraglutide group, but not the sitagliptin group.
TABLE 2.
Comparisons of changes in nutrient intake between the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups following the 14‐week intervention.
| Baseline (mean, SD) | Postintervention (mean, SD) | 14‐Week change (mean, SD) a | Within‐group and unadjusted between‐group p‐values b | Adjusted between‐group p‐value b | |
|---|---|---|---|---|---|
| Energy intake (kcals) | 0.933 | 0.646 | |||
| Liraglutide | 2250 (848) | 1960 (630) | −284 (859) | 0.062 | |
| Caloric restriction | 2020 (811) | 1700 (660) | −322 (1060) | 0.245 | |
| Sitagliptin (control) | 2080 (752) | 1860 (881) | −216 (696) | 0.194 | |
| Carbohydrates (% of kcals) | 0.068 | 0.019 | |||
| Liraglutide | 45.6 (11.1) | 46.0 (8.5) | 0.4 (12.6) d | 0.845 | |
| Caloric restriction | 45.6 (10.5) | 38.6 (10.3) | −7.0 (15.0) d , e | 0.082 | |
| Sitagliptin (control) | 43.5 (9.2) | 46.4 (9.9) | 2.9 (11.5) e | 0.281 | |
| Protein (% of kcals) | 0.207 | 0.037 | |||
| Liraglutide | 15.3 (5.0) | 16.7 (5.6) | 1.4 (7.0) | 0.252 | |
| Caloric restriction | 16.4 (6.1) | 21.0 (8.9) | 4.6 (12.1) | 0.149 | |
| Sitagliptin (control) | 16.1 (3.8) | 15.8 (4.4) | −0.3 (5.3) | 0.840 | |
| Fat (% of kcals) | 0.289 | 0.355 | |||
| Liraglutide | 36.8 (9.1) | 35.2 (7.0) | −1.7 (11.3) | 0.389 | |
| Caloric restriction | 35.6 (7.6) | 38.4 (8.5) | 2.8 (10.5) | 0.307 | |
| Sitagliptin (control) | 38.7 (7.6) | 36.2 (9.1) | −2.4 (9.1) | 0.260 | |
| Saturated fat (% of kcals) | 0.478 | 0.831 | |||
| Liraglutide | 12.1 (4.1) | 11.4 (3.0) | −0.7 (4.6) | 0.372 | |
| Caloric restriction | 11.9 (3.5) | 11.7 (4.4) | −0.2 (5.2) | 0.881 | |
| Sitagliptin (control) | 13.3 (3.7) | 11.4 (4.1) | −2.0 (3.4) | 0.022 | |
| Fibre (g/1000 kcals) | 0.308 | 0.239 | |||
| Liraglutide | 8.3 (3.8) | 9.7 (3.9) | 1.4 (5.4) | 0.149 | |
| Caloric restriction | 10.3 (4.1) | 10.4 (3.8) | 0.1 (4.9) | 0.938 | |
| Sitagliptin (control) | 9.2 (4.1) | 12.1 (6.1) | 2.9 (5.7) | 0.040 | |
| Total sugar (g/1000 kcals) | 0.964 | 0.349 | |||
| Liraglutide | 50.6 (29.6) | 51.0 (19.2) | 0.4 (31.7) | 0.945 | |
| Caloric restriction | 41.4 (24.2) | 39.1 (24.5) | −2.3 (36.0) | 0.802 | |
| Sitagliptin (control) | 47.0 (23.7) | 46.6 (29.5) | −0.4 (31.4) | 0.959 | |
| Added sugar (% of kcals) | 0.192 | 0.002 | |||
| Liraglutide | 13.5 (9.2) | 14.4 (7.4) | 0.9 (10.0) d | 0.604 | |
| Caloric restriction | 10.2 (7.4) | 5.9 (4.5) | −4.3 (8.6) d | 0.066 | |
| Sitagliptin (control) | 10.3 (10.6) | 10.5 (8.6) | 0.2 (9.2) | 0.927 | |
| Glycaemic load c | 0.251 | 0.072 | |||
| Liraglutide | 143 (55.5) | 132 (51.4) | −11.6 (58.5) | 0.256 | |
| Caloric restriction | 130 (67.3) | 89.4 (37.8) | −40.3 (78.4) | 0.058 | |
| Sitagliptin (control) | 129 (78.0) | 120 (83.1) | −8.8 (53.1) | 0.479 | |
Abbreviations: g, grams; kcals, calories.
Actual mean change, not adjusted for baseline, is presented.
Within‐group changes were computed using paired t tests or Wilcoxon signed‐rank tests, dependent upon the normality of the data. Unadjusted between‐group differences were assessed using group‐by‐time ANOVAs. Adjusted between‐group differences were computed using ANCOVAs adjusted for baseline intake.
Glycaemic load calculated using glucose as a reference.
Mean change is significantly different between the liraglutide and caloric restriction groups.
Mean change is significantly different between the caloric restriction and sitagliptin groups.
There were no between‐group differences in micronutrient intake among the three treatment arms (Table S1). However, the liraglutide group significantly increased its vitamin B6 (p = 0.048), vitamin D (p = 0.023) and iron (p = 0.012) intake, while the sitagliptin group significantly decreased its vitamin D intake (p = 0.012) following the 14‐week intervention. No significant within‐group changes in micronutrient intake were detected in the caloric restriction group.
The proportion of participants in the caloric restriction, liraglutide and sitagliptin groups who met the dietary recommendations at the postintervention time point for each individual nutrient is presented in Figure 1. All groups had a small proportion of individuals meeting the vitamin D, fibre, potassium and vitamin E recommendations. Likewise, all groups had a high proportion of participants meeting the recommendations for phosphorus, niacin, iron, riboflavin, protein, thiamin, vitamin B12 and zinc. Notably, while 94% of the participants in the caloric restriction group met the recommendation for added sugar intake (<10% energy), only 32% of the liraglutide group met this recommendation. Of note, only 6% of participants in the caloric restriction group consumed carbohydrates in the recommended proportion of total energy intake (45%–65% energy), and 12% of participants in this group met the recommendation for dietary fibre. The caloric restriction group also had a notably higher proportion of participants meeting the recommendations for pantothenic acid, vitamin C, saturated fat and sodium, compared to the liraglutide group.
FIGURE 1.
Proportion of participants meeting dietary recommendations across the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups at the postintervention time point. Proportions were calculated based on the number of participants in each group meeting the Estimated Average Requirement (EAR), based on sex and age. The EAR was unavailable for fibre, pantothenic acid, potassium and sodium, so the Adequate Intake (AI) was used in place. Carbohydrate, fat and protein intake were compared against the Acceptable Macronutrient Distribution Ranges (AMDRs). Saturated fat and added sugar were compared against the 2020–2025 Dietary Guidelines for Americans recommendation of <10% total caloric intake.
3.3. Diet quality
A priori dietary patterns, derived from HEI‐2020 total and component scores, are detailed in Table 3. After adjusting for baseline intake, there was a significant between‐group difference in the change in HEI added sugar component scores from baseline to postintervention. Post hoc analyses revealed that the caloric restriction group significantly improved its HEI added sugar score compared to the liraglutide group.
TABLE 3.
Comparisons of change in HEI‐2020 total and component scores between the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups following the 14‐week intervention.
| Baseline (mean, SD) | Postintervention (mean, SD) | 14‐Week change (mean, SD) a | Within‐group and unadjusted between‐group p‐values b | Adjusted between‐group p‐value b | |
|---|---|---|---|---|---|
| HEI‐2020 total score (max = 100) | 0.856 | 0.235 | |||
| Liraglutide | 46.9 (12.7) | 47.5 (13.9) | 0.66 (18.2) | 0.849 | |
| Caloric restriction | 50.8 (17.2) | 54.6 (10.3) | 3.77 (17.5) | 0.402 | |
| Sitagliptin (control) | 50.8 (17.1) | 52.3 (15.0) | 1.53 (20.7) | 0.750 | |
| HEI total fruits (max = 5) | 0.254 | 0.451 | |||
| Liraglutide | 1.68 (1.70) | 1.46 (2.02) | −0.22 (2.09) | 0.552 | |
| Caloric restriction | 1.59 (2.18) | 1.90 (1.95) | 0.31 (2.74) | 0.662 | |
| Sitagliptin (control) | 2.26 (2.19) | 1.19 (1.70) | −1.06 (2.86) | 0.123 | |
| HEI whole fruits (max = 5) | 0.107 | 0.263 | |||
| Liraglutide | 2.33 (2.23) | 1.70 (2.30) | −0.63 (2.74) | 0.202 | |
| Caloric restriction | 1.58 (2.24) | 2.60 (2.28) | 1.02 (3.38) | 0.244 | |
| Sitagliptin (control) | 2.57 (2.35) | 1.55 (2.09) | −1.02 (3.10) | 0.121 | |
| HEI total vegetables (max = 5) | 0.899 | 0.283 | |||
| Liraglutide | 2.43 (1.77) | 2.70 (1.57) | 0.28 (2.53) | 0.530 | |
| Caloric restriction | 3.43 (1.36) | 3.47 (1.73) | 0.04 (2.01) | 0.938 | |
| Sitagliptin (control) | 3.32 (1.59) | 3.32 (1.83) | −0.002 (2.20) | 0.997 | |
| HEI greens and beans (max = 5) | 0.557 | 0.335 | |||
| Liraglutide | 1.29 (1.99) | 1.70 (2.33) | 0.42 (3.24) | 0.390 | |
| Caloric restriction | 3.29 (2.17) | 2.71 (2.34) | −0.58 (3.18) | 0.608 | |
| Sitagliptin (control) | 2.05 (2.32) | 1.82 (2.32) | −0.23 (3.25) | 0.684 | |
| HEI whole grains (max = 10) | 0.648 | 0.950 | |||
| Liraglutide | 2.18 (3.34) | 3.24 (3.92) | 1.06 (3.94) | 0.119 | |
| Caloric restriction | 2.88 (4.39) | 3.07 (3.97) | 0.19 (5.64) | 0.893 | |
| Sitagliptin (control) | 3.52 (4.21) | 3.40 (4.06) | −0.12 (5.23) | 0.919 | |
| HEI dairy (max = 10) | 0.946 | 0.371 | |||
| Liraglutide | 4.02 (3.12) | 4.14 (3.32) | 0.12 (3.27) | 0.836 | |
| Caloric restriction | 4.16 (3.38) | 3.99 (3.87) | −0.18 (4.62) | 0.882 | |
| Sitagliptin (control) | 6.49 (2.96) | 6.29 (3.28) | −0.20 (3.97) | 0.830 | |
| HEI total protein foods (max = 5) | 0.994 | 0.885 | |||
| Liraglutide | 4.21 (1.50) | 4.29 (1.50) | 0.08 (1.34) | 0.925 | |
| Caloric restriction | 4.51 (1.00) | 4.57 (1.16) | 0.06 (1.67) | 0.944 | |
| Sitagliptin (control) | 4.19 (1.23) | 4.23 (1.43) | 0.04 (1.29) | 1.000 | |
| HEI seafood and plant proteins (max = 5) | 0.014 | 0.124 | |||
| Liraglutide | 2.64 (2.35) | 1.81 (2.36) | −0.84 (2.79) | 0.072 | |
| Caloric restriction | 3.08 (2.30) | 1.59 (2.26) | −1.49 (3.01) | 0.108 | |
| Sitagliptin (control) | 1.54 (2.09) | 2.90 (2.38) | 1.36 (3.45) | 0.126 | |
| HEI fatty acids (max = 10) | 0.318 | 0.465 | |||
| Liraglutide | 5.01 (3.67) | 4.91 (3.74) | −0.10 (4.73) | 0.902 | |
| Caloric restriction | 4.47 (3.87) | 6.29 (3.97) | 1.82 (5.23) | 0.185 | |
| Sitagliptin (control) | 3.73 (3.47) | 5.36 (4.28) | 1.63 (5.10) | 0.180 | |
| HEI refined grains (max = 10) | 0.780 | 0.458 | |||
| Liraglutide | 5.33 (4.12) | 5.77 (4.11) | 0.43 (5.09) | 0.624 | |
| Caloric restriction | 5.74 (4.02) | 7.26 (3.76) | 1.52 (5.49) | 0.287 | |
| Sitagliptin (control) | 5.44 (3.92) | 6.46 (3.36) | 1.02 (5.25) | 0.409 | |
| HEI sodium (max = 10) | 0.383 | 0.069 | |||
| Liraglutide | 4.57 (3.75) | 4.46 (3.59) | −0.11 (4.42) | 0.889 | |
| Caloric restriction | 3.61 (3.82) | 2.81 (3.35) | −0.80 (5.72) | 0.585 | |
| Sitagliptin (control) | 4.43 (3.80) | 2.29 (3.19) | −2.14 (5.66) | 0.117 | |
| HEI added sugars (max = 10) | 0.116 | 0.002 | |||
| Liraglutide | 6.15 (3.69) | 5.79 (3.48) | −0.36 (3.91) c | 0.596 | |
| Caloric restriction | 7.40 (2.97) | 9.40 (1.74) | 2.00 (3.72) c | 0.048 | |
| Sitagliptin (control) | 7.36 (4.04) | 7.67 (3.27) | 0.31 (3.23) | 0.684 | |
| HEI saturated fats (max = 10) | 0.340 | 0.629 | |||
| Liraglutide | 5.04 (3.83) | 5.51 (3.06) | 0.47 (4.69) | 0.564 | |
| Caloric restriction | 5.10 (3.78) | 4.96 (4.20) | −0.14 (5.26) | 0.916 | |
| Sitagliptin (control) | 3.85 (3.32) | 5.81 (3.48) | 1.96 (3.03) | 0.011 |
Abbreviations: HEI, Healthy Eating Index; Max, maximum.
Actual mean change, not adjusted for baseline, is presented.
Within‐group changes were computed using paired t tests or Wilcoxon signed‐rank tests, dependent upon the normality of the data. Unadjusted between‐group differences were assessed using group‐by‐time ANOVAs. Adjusted between‐group differences were computed using ANCOVAs adjusted for baseline intake.
Mean change is significantly different between the liraglutide and caloric restriction group (p = 0.002).
A comparison of postintervention HEI‐2020 component scores to recommended intakes is presented in Figure 2. All groups had high HEI component scores for protein (liraglutide: 4.3 ± 1.5; caloric restriction: 4.6 ± 1.2; sitagliptin: 4.2 ± 1.4; out of 5). Meanwhile, all groups scored fairly low for whole grains (liraglutide: 3.2 ± 3.9; caloric restriction: 3.1 ± 4.0; sitagliptin: 3.4 ± 4.1; out of 10) and total fruits (liraglutide: 1.5 ± 2.0; caloric restriction: 1.9 ± 2.0; sitagliptin: 1.2 ± 1.7; out of 5) HEI component scores. The caloric restriction group had a nearly perfect score (9.4 ± 1.7 out of 10) for added sugar intake, aligning with the Dietary Guidelines for Americans' recommendation to limit added sugar, while the liraglutide group had the lowest score of the three groups for added sugar intake (5.8 ± 3.5 out of 10). In addition to this, the caloric restriction group presented the highest scores for whole fruit (2.6 ± 2.3 out of 5), greens and beans (2.7 ± 2.3 out of 5), fatty acids (6.3 ± 4.0 out of 10) and refined grains (7.3 ± 3.8 out of 10) among the three treatment arms.
FIGURE 2.
Postintervention HEI‐2020 component scores compared to recommended intakes across the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups. Higher scores more closely align with the recommendations of the 2020–2025 Dietary Guidelines for Americans to either consume an adequate amount of, or limit, specific food components.
3.4. Dietary patterns
At postintervention, none of the treatment arms met the 2020–2025 Dietary Guidelines for Americans recommendations for fruits, vegetables or dairy intake and all groups exceeded the protein recommendation. Only the caloric restriction group's mean grain intake fell below the recommendations (Table S2). There were no significant between‐ or within‐group differences in fruit, vegetable, grain, dairy or protein intake. Most notable, however, were differences observed in the top three food sources contributing to each food group. At the postintervention time point, the top sources of grains in the caloric restriction group were whole grain products, whereas the top three grains consumed by the liraglutide group consisted entirely of refined grains, including pastries and pasta. Similarly, at the postintervention time point, sweetened low‐fat yogurt was among the top sources of dairy in the caloric restriction group, whereas frozen dairy desserts (e.g., ice cream) were among the top sources of dairy in the liraglutide and sitagliptin groups. With regard to protein intake, the caloric restriction group primarily consumed lean protein sources, while nonlean beef was a frequent protein source in the liraglutide and sitagliptin groups.
4. DISCUSSION
Research and clinical practice have established the efficacy of using AOMs for weight loss by means of reductions in hunger, appetite and ‘food noise’; however, no studies to date have measured changes in usual dietary intake after AOM initiation. 19 This study is among the first to use rigorously collected dietary intake data to describe changes in diet made by AOM users (without nutrition therapy) compared to caloric restriction and a weight‐neutral placebo control group. While the liraglutide group reduced their energy intake by 13% over the 14‐week intervention, this secondary analysis showed there were very few notable group‐by‐time changes in usual dietary intake, dietary quality or dietary patterns. The exception was that the AOM group had the poorest HEI added sugar score at the postintervention time point. Our findings also revealed that, like the caloric restriction and control groups, the liraglutide group fell short of several dietary recommendations and could benefit from concomitant nutrition therapy. Studies evaluating changes in dietary intake among AOM users are needed to determine how to tailor nutrition therapy to optimize the health benefits of weight loss.
Our findings suggested that weight loss among AOM users was driven by a generalized reduction of energy intake. The liraglutide group did not significantly alter their macro‐ or micronutrient intake compared to the control group. These findings are comparable to a randomized, double‐blinded, placebo‐controlled crossover trial published by Flint et al., who showed that while liraglutide significantly reduced ad libitum energy intake following a standardized meal compared to the placebo, the percent of calories from protein, fat and carbohydrates did not significantly differ. 39 Similar findings were reported with regard to macronutrient intake in a randomized crossover trial assessing ad libitum intake following a standardized meal upon semaglutide initiation. 40 Unique to the current study were our observations related to diet quality and comparisons of usual intake to dietary recommendations. Although differences in diet quality were not statistically significant, the mean HEI‐2020 score was lowest in the liraglutide group (47.5/100) compared to the caloric restriction (54.6) and sitagliptin (52.3) groups, all of which fell below the U.S. average of 58. 41 This is meaningful as higher HEI scores are associated with reductions in the risk of cardiovascular disease, type 2 diabetes, cancer and all‐cause mortality. 42 The liraglutide group also had the poorest HEI added sugar score, which worsened over the 14‐week intervention compared to the caloric restriction group, who significantly improved their HEI added sugar score. This may be attributed to the caloric restriction group's meetings with a Registered Dietitian, whose education included low‐calorie substitutions, limiting ‘empty’ calories and tracking macronutrients. This finding also is supported by our a posteriori diet pattern analysis that revealed the top sources of grains and dairy in the AOM group included refined pastries and frozen desserts, whereas in the caloric restriction group, the top sources of grains and dairy were mostly whole grain and reduced fat. Despite limited observed differences in changes to dietary intake over time compared to the caloric restriction and placebo control groups, there were notable areas for improvement that could help support AOM users. 43
This study supports the need for concomitant nutrition therapy for AOM users that is focused on improving diet quality and meeting key dietary recommendations to optimize outcomes and treat or prevent medication side effects. Based on our findings, these recommendations would include increasing whole grain and fibre intake and limiting added sugar intake, which may additionally help to alleviate medication‐related gastrointestinal discomfort and constipation. 18 Other recommendations would include consuming more fruits and vegetables and choosing low‐fat dairy and proteins to reduce saturated fat while providing key micronutrients—such as vitamins C, D, E and K, calcium, folate, pantothenic acid, potassium and magnesium—which many AOM users under consumed relative to the Dietary Reference Intakes. If dietary recommendations cannot be met through food alone, supplementation—particularly with multivitamins, calcium and vitamin D—may also be considered. 12 , 18 Future research is needed to help refine nutrition therapy targets to support AOM users with achieving optimal health outcomes.
This study had several notable strengths. First, the lack of intentional caloric restriction for participants in the liraglutide and weight‐neutral groups allowed for an examination of how AOMs independently influence dietary intake, quality and patterns in comparison to dietitian‐supported caloric restriction and the weight‐neutral group. Another strength is that this is the first study, to our knowledge, to use gold‐standard 24‐h dietary recall methodology to assess changes in dietary intakes among AOM users. In contrast, most prior investigations have assessed ad libitum intake following a standardized test meal. 19 Nonetheless, this study also had several limitations. The study was limited by sample size, which limits drawing definitive conclusions from the study findings and restricts the ability to make comparisons among subgroups such as by sex, race/ethnicity, age or baseline BMI. Thus, more research is needed to assess the impact of GLP‐1 receptor agonists on dietary intakes in larger, diverse samples to better support specific nutrition recommendations. Post hoc power analyses indicated that the study had sufficient power to detect large effect sizes but was underpowered for detecting smaller effects. Notably, the present analyses enable determining the sample size for future trials. Another limitation is that dietary intake was measured using a single dietary recall at each time point, which may skew the results if a typical day's intake was not captured. While a single recall was appropriate for the objectives of this study to determine differences among groups, 34 research using more than one diet recall is needed to capture the day‐to‐day variability that may occur on an individual basis. Further, given the exploratory nature of this study, correction for multiple comparisons was not performed. While this approach allowed for hypothesis generation that can be tested through larger, more diverse trials, it increases the potential for Type I error. Finally, the dosage used for liraglutide treatment was 1.8 mg/day, which is substantially lower than the current recommendation of 3.0 mg/day for weight loss, limiting the generalizability of findings.
5. CONCLUSIONS
Overall diet quality remained poor across all groups, with no significant difference in the change in total diet quality between those randomized to liraglutide, sitagliptin and caloric restriction. However, the benefits of nutrition intervention emerged, such that those in the caloric restriction group significantly reduced their added sugar intake compared to the liraglutide group. These findings, coupled with the poor diet quality observed, support the need for dietitian‐provided nutrition therapy for people using AOMs. Further research is needed to replicate these findings and to determine the long‐term impact of AOM use on dietary intake and the impact of dietary changes on clinical outcomes. Collectively, these data can be used to inform the development of nutrition therapy guidelines for this population.
CONFLICTS OF INTERESTS STATEMENT
KMR reports consultancy to Weight Watchers International, Inc, outside the submitted work. SMS reports unpaid consultation for Viocare. MRJ reports former consultation to ZOE. All other authors declare no competing interests.
PEER REVIEW
The peer review history for this article is available at https://www.webofscience.com/api/gateway/wos/peer‐review/10.1111/dom.16395.
Supporting information
Table S1. Comparisons of changes in micronutrient intake between the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups following the 14‐week intervention.
Table S2. Comparisons of a posteriori dietary patterns identified among the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups following the 14‐week intervention.
ACKNOWLEDGEMENTS
None.
Richardson KM, Schembre SM, Jospe MR, Widmer A, Silver HJ. The influence of the glucagon‐like peptide‐1 receptor agonist, liraglutide, on dietary patterns and nutrient intakes in patients with obesity and prediabetes: A secondary analysis of a randomized controlled trial. Diabetes Obes Metab. 2025;27(7):3725‐3735. doi: 10.1111/dom.16395
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Table S1. Comparisons of changes in micronutrient intake between the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups following the 14‐week intervention.
Table S2. Comparisons of a posteriori dietary patterns identified among the liraglutide (N = 34), caloric restriction (N = 16) and sitagliptin (N = 19) groups following the 14‐week intervention.
Data Availability Statement
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.