Study of Dietary Changes to Lower Gut Flora Metabolite TMAO and Reduce Cardiovascular Risk

What this Trial Is About

Researchers are investigating how gut flora-associated metabolites, specifically trimethylamine-N-oxide TMAO, relate to cardiovascular risk and whether dietary changes can reduce TMAO levels. This pilot human study aims to understand the production of TMAO from gut flora in people with different circulating TMAO levels and to test if tailored diets can lower TMAO generation in those with elevated levels. Participants are assigned to one of three dietary interventions a Mediterranean Low-TMAO MeLT diet, a Therapeutic Lifestyle Changes TLC diet based on American Heart Association guidelines, or a MeLT diet with TMAO levels provided to participants for guidance. These diets are applied across different cohorts with the intervention lasting for 12 weeks. During the study, participants follow their assigned diet and are monitored for changes in TMAO levels from baseline to 12 weeks. Researchers assess TMAO generation using stable-isotope-labelled nutrients and evaluate the impact of dietary changes on cardiovascular risk factors. Participants also maintain consistent aspirin use or abstinence as per study requirements. The study includes screening, dietary intervention, and follow-up assessments to measure outcomes and ensure safety.

Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)