NCT02016430

Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Our group has recently identified the association between gut-flora-mediated carnitine and phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and cardiovascular risk. This study investigates the ability for dietary intervention to modulate TMAO levels.

Detailed description

This is a pilot human study to characterize the relationship between gut flora-associated TMAO generation and dietary intervention. The investigators hypothesize that tailored dietary interventions may help to reduce the ability for gut flora to generate TMAO in individuals with elevated TMAO levels. Specific aims include: 1. To investigate the proportion of subjects with persistently elevated circulating TMAO levels. 2. To compare the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated versus normal circulating TMAO levels. 3. To evaluate the effect of dietary interventions on the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated circulating TMAO levels.

Conditions

• Dietary Modification
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
BEHAVIORAL	MeLT Dietary intervention	Mediterranean diet containing food with low TMAO content.
BEHAVIORAL	TLC Dietary intervention	Standard American Heart Association (AHA) recommendations for dietary counseling.
BEHAVIORAL	MeLT dietary intervention with TMAO	Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.

Timeline

• Start date: 2014-04-04
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2013-12-20
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States