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

February 24, 2026 updated by: Athletic Greens International
This study is a triple-blind, placebo-controlled, randomized controlled trial of 120 adults that will evaluate the impact of a novel nutritional supplement on improving nutrient gaps and changing nutrient status and the gut microbiome among glucagon-like peptide-1 receptor agonist (GLP-1 RA) users.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary Supplement: AG1 - Nutritional Supplement
AG1 - Nutritional Supplement
Dietary supplement: AG1 - Nutritional Supplement
AG1 - Nutritional Supplement
Placebo Comparator: Dietary Supplement: Placebo
Dietary supplement: Placebo
Maltodextrin Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrient Gaps
Time Frame: 90 days
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrient Status Markers
Time Frame: 90 days
Circulating concentrations of nutrient status (homocysteine, folate, Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamin, Riboflavin, Niacin, Vitamin B6, Vitamin B12, Zinc)
90 days
Gut Microbiome
Time Frame: 90 days
Examine changes in the gut microbiome via fecal metagenomics
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
GI Symptoms
Time Frame: 90 days
The Gastrointestinal Symptom Rating Scale will be provided to assess the effect of the intervention on GI symptoms. Scores range from 1 to 7 with a higher score indicating a higher level of discomfort
90 days
Digestive Quality of Life
Time Frame: 90 days
A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life
90 days
Functional Impairment
Time Frame: 90 days
The Sheehan Disability Scale will be utilized to assess functional impairment.
90 days
Ingestive Behavior
Time Frame: 90 days
Food cravings will be measured using the General Food Cravings Questionnaire.
90 days
Energy
Time Frame: 90 days
The Fatigue Assessment Scale will be utilized to assess the impact of the intervention on symptoms of fatigue.
90 days
Serum concentrations of sodium
Time Frame: 90 days
Measured using a Comprehensive Metabolic Panel
90 days
Serum concentrations of Potassium
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of carbon dioxide
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of chloride
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of albumin
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of total protein
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of glucose
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of calcium
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of ALT
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of AST
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of bilirubin
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days
Serum concentrations of Blood Urea Nitrogen
Time Frame: 90 days
Measured in a Comprehensive Metabolic Panel
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athletic Greens International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 20815

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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