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Gut Flora Metabolite Reduction After Dietary Intervention (GRADY) — GRADY  

Cardiovascular Risk Factor Clinical Trial

Official title:
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02016430
Study type Interventional
Source The Cleveland Clinic
Contact Jennifer Wilcox
Phone 216-636-6153
Email kirsopj@ccf.org
Status Recruiting
Phase N/A
Start date April 4, 2014
Completion date December 2026
View Details
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