Actively Recruiting
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
Led by Athletic Greens International · Updated on 2026-02-27
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new nutritional supplement's effects on nutrient gaps, nutrient status, and gut microbiome health in adults using glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This triple-blind, placebo-controlled, randomized trial involves 120 participants aged 18 to 59 years. The study aims to better understand how this supplement might influence nutrition and gut health among GLP-1 RA users. Participants are randomly assigned to receive either the AG1 nutritional supplement or a placebo made of maltodextrin. The study maintains triple blinding to ensure unbiased results. The treatment period lasts 90 days, during which participants follow their usual GLP-1 RA maintenance dose without changes. The trial monitors nutrient gaps, nutrient status markers, and gut microbiome changes at the end of this period. Throughout the study, participants must adhere to specific protocols including maintaining current diet, sleep, and activity levels, avoiding new supplements or medications, and following pre-test restrictions such as fasting and avoiding caffeine and exercise before blood tests. Researchers collect data on nutrient and microbiome outcomes and monitor adherence through reported behaviors and weighing scale access. The total participation duration is 90 days, with detailed assessments to evaluate the supplement's impact safely and accurately.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be male or female
- Be aged 18 to 59 years
- Have a body mass index (BMI) between 20 and 31.9
- Currently taking GLP-1 medication at maintenance dose (week 8 or more) with no plans to change dosage
- Willing to follow study protocol, including diet duplication before blood tests, avoiding caffeine and exercise, and fasting
- Willing to maintain current diet, sleep, and activity levels during the trial
- Willing to avoid other supplements, medications, or herbal remedies during the trial
- Generally healthy without diagnosed uncontrolled chronic disease
- Have access to a consistent weighing scale for the study duration
- Reside in the United States
You will not qualify if you...
- Diagnosis of Type I or Type II diabetes
- Diagnosis of metabolic health conditions, such as hypertension or dyslipidemia
- Use of multivitamin or multimineral supplements within the past 3 months
- Use of probiotic supplements within the past month
- Regular consumption (5 days/week or more) of products targeting healthy aging, longevity, gut health, energy, or cravings within the past 2 months
- Received antibiotic, antifungal, antiparasitic, or antiviral treatment within the past 90 days
- History of severe digestive disorders or metabolic conditions affecting nutrient absorption or metabolism
- Allergies or hypersensitivity to any supplement ingredients
- Chronic health conditions impacting study participation, including asthma, gout, fibromyalgia, inflammatory conditions, thyroid issues, recent cancer, mental health disorders, recent serious illness, substance abuse, or planned surgery
- Currently pregnant, trying to conceive, or breastfeeding
- Recent change in hormone therapy or unwillingness to maintain current hormone therapy throughout the study
- Consumes more than 2 standard alcoholic drinks per day or 10 drinks per week, or has within the past 6 months
- Current smoker or smoked within the past month
- Follows specific exclusion diets such as vegan, vegetarian, carnivore, paleo, Atkins, or ketogenic
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants take either the nutritional supplement or a placebo while maintaining their usual diet, sleep, and activity levels.
Baseline visit and follow-up visits during treatment period
Trial Site Locations
Total: 1 location
1
Citruslabs
Santa Monica, California, United States, 90404-3727
Actively Recruiting
Research Team
E
Ellen O'Gorman
J
Jodi Nicolli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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