CClinicalTrials.gg
RecruitingNCT07437911Updated Feb 27, 2026

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

An interventional study of AG1 - Nutritional Supplement and Placebo in Nutrition Intake, Nutrition Status and Gastrointestinal Microbiome, sponsored by Athletic Greens International. Recruiting at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Athletic Greens International · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Nutrition Intake
  • Nutrition Status
  • Gastrointestinal Microbiome
  • GLP-1
03

In context

Lead sponsor

Athletic Greens International is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Dietary Supplement: AG1 - Nutritional Supplement

    AG1 - Nutritional Supplement

    Dietary Supplement: AG1 - Nutritional Supplement

  • Placebo comparator
    Dietary Supplement: Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAG1 - Nutritional Supplement

    AG1 - Nutritional Supplement

  • Dietary supplementPlacebo

    Maltodextrin Placebo

06

What researchers measure

Primary outcomes

  1. Nutrient Gaps

    Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool

    Time frame: 90 days

Secondary outcomes

  1. Nutrient Status Markers

    Circulating concentrations of nutrient status (homocysteine, folate, Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamin, Riboflavin, Niacin, Vitamin B6, Vitamin B12, Zinc)

    Time frame: 90 days

  2. Gut Microbiome

    Examine changes in the gut microbiome via fecal metagenomics

    Time frame: 90 days

Other outcomes

  1. GI Symptoms

    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

    Time frame: 90 days

  2. Digestive Quality of Life

    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

    Time frame: 90 days

  3. Functional Impairment

    The Sheehan Disability Scale will be utilized to assess functional impairment.

    Time frame: 90 days

  4. Ingestive Behavior

    Food cravings will be measured using the General Food Cravings Questionnaire.

    Time frame: 90 days

  5. Energy

    The Fatigue Assessment Scale will be utilized to assess the impact of the intervention on symptoms of fatigue.

    Time frame: 90 days

  6. Serum concentrations of sodium

    Measured using a Comprehensive Metabolic Panel

    Time frame: 90 days

  7. Serum concentrations of Potassium

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  8. Serum concentrations of carbon dioxide

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  9. Serum concentrations of chloride

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  10. Serum concentrations of albumin

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  11. Serum concentrations of total protein

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  12. Serum concentrations of glucose

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  13. Serum concentrations of calcium

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  14. Serum concentrations of ALT

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  15. Serum concentrations of AST

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  16. Serum concentrations of bilirubin

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

  17. Serum concentrations of Blood Urea Nitrogen

    Measured in a Comprehensive Metabolic Panel

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Citruslabs
    Santa Monica, California 90404-3727, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07437911
Lead sponsor
Athletic Greens International
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Feb 2026 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Ellen O'Gorman
Contact
ellen@citruslabs.com
(805) 292-0714
Jodi Nicolli
Contact
jodi@citruslabs.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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