Study on Effects of a Ready-to-Mix Health and Wellness Beverage on Gut and Overall Health in Adults Using GLP-1 or Trying to Lose Weight

What this Trial Is About

Researchers are evaluating the effects of a health and wellness product on gastrointestinal health and related outcomes in adults aged 21 to 75. This study aims to understand user experiences, side effects, product acceptance, and health impacts in people currently using GLP-1 medications for at least 3 months or those interested in losing weight but not on GLP-1 therapy. The study is sponsored by PepsiCo Global R&D and uses self-reported measures and biomarker collections to assess outcomes. Participants will consume a ready-to-mix beverage containing protein, fiber, and electrolytes freely over a 4-week period. The study includes adults who either have been taking GLP-1 for 3 months or longer without plans to stop or switch, or those interested in weight loss but not currently using GLP-1 and with no plans to start. Biomarker collections of stool and blood samples will occur at the start and end of the intervention period. During the study, participants will complete electronic surveys measuring constipation, belly pain, digestion quality of life, satiety, and self-reported weight at baseline and weekly during the 4 weeks. They will also keep a 24-hour food diary at the beginning and end of the study. Researchers will monitor participant health and product effects through these assessments and biomarker samples. The study is open label with no blinding, and participants must have reliable internet access to complete electronic surveys and biomarker collections. Total participation lasts for the 4-week intervention.

An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes