A nutritional supplement to fill nutrient gaps and support gut health for people taking GLP-1 medications.

A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Supplement on Nutrient Gaps and Gut Health Among Individuals Utilizing GLP-1 RAs

This study will test whether a daily nutritional supplement can reduce nutrient gaps and improve the gut microbiome in adults who are using GLP-1 receptor agonist medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Athletic Greens International (Industry-sponsored)
• Locations: 1 site (Santa Monica, California)
• Trial ID: NCT07437911 on ClinicalTrials.gov

What this trial studies

This randomized, triple-blind, placebo-controlled trial will enroll 120 adults on stable GLP-1 receptor agonist therapy to compare a daily nutritional supplement (AG1) against a matching placebo. Eligible participants are aged 18–59 with BMI 20–31.9 and on a maintenance GLP-1 dose for at least eight weeks; they will follow a standardized protocol including blood draws and stool sampling for microbiome analysis. Participants must duplicate their diet for 72 hours before blood tests, refrain from caffeine and exercise for 24 hours, and fast for 10 hours prior to testing, and they are asked to maintain usual diet, sleep, and activity and avoid other supplements during the trial. Study visits are conducted at Citruslabs in Santa Monica, California.

Who should consider this trial

Good fit: Adults 18–59 with BMI 20–31.9 who have been on a stable maintenance dose of a GLP-1 receptor agonist for at least eight weeks and are generally healthy are the ideal candidates.

Not a fit: People with uncontrolled chronic diseases, those outside the age or BMI criteria, those planning to change GLP-1 dosing, or those already taking other supplements would likely not benefit or be eligible.

Why it matters

Potential benefit: If successful, the supplement could help people on GLP-1 medications correct nutrient shortfalls and support a healthier gut microbiome.

How similar studies have performed: Previous trials of multinutrient supplements have shown mixed results for correcting deficiencies and altering the gut microbiome, so applying this approach specifically to stable GLP-1 users is relatively novel with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

* Be male or female
* Be aged 18-59.
* Has a BMI between 20-31.9.
* Anyone currently taking GLP-1 medication at their maintenance dose (week 8+), and without any plans to alter their dosage. This includes: Semaglutide (Ozempic®, Wegovy®, Rybelsus®), Liraglutide (Saxenda®, Victoza®), Dulaglutide (Trulicity®), Exenatide (Byetta®, Bydureon®), Lixisenatide (Adlyxin®)
* Anyone willing to follow the study protocol, including immediately prior to the all blood tests, duplicating their diet for 72 hours (3 days), refraining from caffeine and exercise for 24 hours, and fasting for 10 hours.
* Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.
* Anyone willing to avoid introducing any other supplements, medications, or herbal remedies for the duration of this trial.
* Anyone who is generally healthy - does not live with any diagnosed uncontrolled chronic disease.
* Has access to a consistent weighing scale for the duration of the study.
* Resides in the United States.

Exclusion Criteria:

* Anyone with a diagnosis of Type I or Type II diabetes.
* Anyone with a diagnosis of any metabolic health condition, such as hypertension and dyslipidemia.
* Anyone who has taken any multivitamin/multimineral supplements within the past 3 months.
* Anyone who has taken a probiotic supplement within the past month.
* Anyone who has regularly consumed (5 days/week or more) products that target healthy aging, anti-aging, longevity, gut health, energy, or ingestive behaviour (such as cravings), including resveratrol, quercetin, pterostilbene, coQ10, grapefruit, nicotinamide riboside, prebiotic fiber, green tea, niacin (vitamin B3) within the past 2 months.
* Anyone who has received an antibiotic, antifungal, antiparasitic, or antiviral treatment within the past 90 days.
* Anyone who has a known history of severe digestive disorders or metabolic conditions that impact nutrient absorption or metabolism, including acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, a history of colon resection, gastroparesis, Inborn errors of metabolism (such as PKU), or gastrointestinal tract surgeries.
* Anyone with any known allergies or hypersensitivities to any supplement product ingredients.
* Anyone with any chronic health conditions that could impact participation in this study, such as asthma, gout, fibromyalgia, chronic inflammatory conditions (such as Crohn's, Lupus, HIV/AIDS), thyroid conditions, cancer (within the past 5 years), mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
* Anyone currently pregnant, trying to conceive, or breastfeeding.
* Anyone who has undergone a change in hormone therapy (including oral contraceptives) within the past 4 weeks, or is unwilling to maintain their current hormone therapy/oral contraceptive use throughout the course of the study.
* Anyone who consumes more than 2 standard alcoholic drinks per day or more than 10 drinks per week, or has within the past 6 months.
* Anyone who is currently a smoker or has been a smoker within the past month.
* Anyone who follows a specific exclusion diet, including vegan, vegetarian, carnivore, paleo, atkins, or ketogenic.

Where this trial is running

Santa Monica, California

• Citruslabs — Santa Monica, California, United States (Recruiting)

Study contacts

• Study coordinator: Ellen O'Gorman

Conditions Nutrition Intake; Nutrition Status; Gastrointestinal Microbiome; GLP-1