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
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2026
CompletedFirst Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
CompletedFebruary 27, 2026
February 1, 2026
6 months
February 20, 2026
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Nutrient Gaps
Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
90 days
Secondary Outcomes (2)
Nutrient Status Markers
90 days
Gut Microbiome
90 days
Other Outcomes (17)
GI Symptoms
90 days
Digestive Quality of Life
90 days
Functional Impairment
90 days
- +14 more other outcomes
Study Arms (2)
Dietary Supplement: AG1 - Nutritional Supplement
EXPERIMENTALAG1 - Nutritional Supplement
Dietary Supplement: Placebo
PLACEBO COMPARATORInterventions
AG1 - Nutritional Supplement
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Citruslabs
Santa Monica, California, 90404-3727, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2026
First Posted
February 27, 2026
Study Start
February 1, 2026
Primary Completion
August 1, 2026
Study Completion
August 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02