Nutrition IntakeNCT07437911
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
A study testing AG1 - Nutritional Supplement in people with Nutrition Intake and Nutrition Status, run by Athletic Greens International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Nutrition Intake, Nutrition Status, Gastrointestinal Microbiome
- What is being tested?
- AG1 - Nutritional Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jodi Nicolli contact
United States1 site, 1 recruiting
- Recruiting
Citruslabs
Santa Monica, California, 90404-3727
Principal Investigator, (805) 292-0714, ellen@citruslabs.com
Director of Customer Success, jodi@citruslabs.com
About this study
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.
- Conditions
- Nutrition Intake, Nutrition Status, Gastrointestinal Microbiome, GLP-1
- Being tested
- AG1 - Nutritional Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG1 - Nutritional SupplementDietary supplement
AG1 - Nutritional Supplement
PlaceboDietary supplement
Maltodextrin Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: AG1 - Nutritional Supplement | Experimental | AG1 - Nutritional Supplement Receives: Dietary Supplement: AG1 - Nutritional Supplement |
| Dietary Supplement: Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient Gaps
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
Measured: 90 days
Secondary outcomes (2)
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)
Measured: 90 days
Gut Microbiome
Examine changes in the gut microbiome via fecal metagenomics
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athletic Greens International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437911
- Sponsor's protocol ID
- 20815
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07437911
- Acronym / sponsor ID
- 20815
- Conditions
- Nutrition Intake, Nutrition Status, Gastrointestinal Microbiome, GLP-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Athletic Greens InternationalIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: AG1 - Nutritional Supplement | Experimental | Dietary Supplement: AG1 - Nutritional SupplementAG1 - Nutritional Supplement |
| Dietary Supplement: Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG1 - Nutritional SupplementAG1 - Nutritional Supplement | Dietary supplement | Dietary Supplement: AG1 - Nutritional Supplement |
| PlaceboMaltodextrin Placebo | Dietary supplement | Dietary Supplement: Placebo |
Primary outcome
Nutrient Gaps
Time frame: 90 days
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
2 secondary outcomes
Nutrient Status Markers
Time frame: 90 days
Gut Microbiome
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jodi Nicolli contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AG1 - Nutritional Supplement in people with Nutrition Intake and Nutrition Status, run by Athletic Greens International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen O'Gorman ((805) 292-0714, ellen@citruslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrient Gaps (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.