Study of Ingestible Mini-Pills to Collect Gut Samples and Compare Effects of Meat and Plant-Based Diets in Adults Aged 50 to 75

What this Trial Is About

Researchers are investigating whether a noninvasive, ingestible device called a mini-pill can collect samples from two different locations in the gastrointestinal GI tract after people consume diets with different protein sources, such as meat and plant-based meat alternatives. This proof-of-concept study aims to analyze the microbial content collected by the mini-pills and stool samples, alongside blood biomarkers related to cardiometabolic risk, to better understand how diet, gut microbiota, and health are connected. Participants will follow two dietary phases in a randomized, double-blind crossover design, each lasting up to three weeks. During these periods, they will consume two daily entrees composed either of meat or plant-based meat alternatives. After two weeks on each diet, participants will swallow six mini-pills along with a blue food coloring dissolved in water. The mini-pills, designed to sample different gut locations, will be recovered from stool collected at home over several days. This protocol allows researchers to observe diet-induced changes in the gut microbiota over time. Participants will provide stool samples until all mini-pills are recovered, which may take two to six days. Researchers will analyze microbial profiles from the mini-pills and stool, as well as measure blood markers linked to cardiometabolic risk. The study requires participants to collect and return multiple stool samples, maintain certain dietary restrictions, and remain in the study area during the intervention. The overall study duration for each participant is approximately eight weeks, including diet phases and sample collection.

Gut Mini-Pill Study