The Cleveland Clinic
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.
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…
Inclusion Criteria: Cohort 1 Inclusion criteria: * Men and women age 18 years or above. * Elevated TMAO metabolizers (\>5 µM) based on screening test and/or eGFR \< 60 at most recent measurement. * Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study. * Willing to sign the consent form and follow the study protocol, which includes a 12-week dietary modification. Cohort 2 Inclusion criteria: * Men and women age 18 years or above. * Willing to remain on aspiri…
Mediterranean diet containing food with low TMAO content.
Standard American Heart Association (AHA) recommendations for dietary counseling.
Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.
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