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Recruiting NCT07437911

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

No phase Interventional Nutrition Intake Nutrition Status Gastrointestinal Microbiome GLP-1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AG1 - Nutritional Supplement, Placebo.
Who it may be relevant to
Registry conditions: Nutrition Intake, Nutrition Status, Gastrointestinal Microbiome, GLP-1. Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement AG1 - Nutritional Supplement
    AG1 - Nutritional Supplement
  • Dietary supplement Placebo
    Maltodextrin Placebo

Primary outcome measures

  • Nutrient Gaps [Time frame: 90 days]
Secondary outcome measures (2)
  • Nutrient Status Markers [Time frame: 90 days]
  • Gut Microbiome [Time frame: 90 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Citruslabs — Santa Monica

Identifiers

NCT: NCT07437911 · 20815

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗