Study to Test a Nutritional Supplements Effect on Nutrient Gaps and Gut Health in Adults Using GLP-1 Medications

What this Trial Is About

Researchers are evaluating a new nutritional supplements effects on nutrient gaps, nutrient status, and gut microbiome health in adults using glucagon-like peptide-1 receptor agonists GLP-1 RAs. This triple-blind, placebo-controlled, randomized trial involves 120 participants aged 18 to 59 years. The study aims to better understand how this supplement might influence nutrition and gut health among GLP-1 RA users. Participants are randomly assigned to receive either the AG1 nutritional supplement or a placebo made of maltodextrin. The study maintains triple blinding to ensure unbiased results. The treatment period lasts 90 days, during which participants follow their usual GLP-1 RA maintenance dose without changes. The trial monitors nutrient gaps, nutrient status markers, and gut microbiome changes at the end of this period. Throughout the study, participants must adhere to specific protocols including maintaining current diet, sleep, and activity levels, avoiding new supplements or medications, and following pre-test restrictions such as fasting and avoiding caffeine and exercise before blood tests. Researchers collect data on nutrient and microbiome outcomes and monitor adherence through reported behaviors and weighing scale access. The total participation duration is 90 days, with detailed assessments to evaluate the supplements impact safely and accurately.

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