Choline Supplementation and Cardiovascular Health

  • days left to enroll
  • participants needed
  • sponsor
    Virginia Polytechnic Institute and State University
Updated on 24 April 2022
cardiovascular disease
trimethylamine n-oxide
Accepts healthy volunteers


Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort studies. The relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO impairs vascular function in humans is not known. The purpose of this study is to determine if acute supplementation of dietary choline, which increases TMAO, impairs vascular function.

Condition Cardiovascular Risk Factor
Treatment Placebo, Choline
Clinical Study IdentifierNCT03646175
SponsorVirginia Polytechnic Institute and State University
Last Modified on24 April 2022


Yes No Not Sure

Inclusion Criteria

-65 years old
Weight stable for previous 6 months (±2.0 kg)
BMI <35 kg/m^2
Verbal and written informed consent
Approved for participation by study medical director (Jose Rivero, M.D.)

Exclusion Criteria

Obese (BMI>35 kg/m2)
Altered dietary patterns within the last month of recruitment
Unstable heart disease or diabetes
Untreated high blood pressure or high cholesterol
Allergies to choline
Unvaccinated against COVID-19
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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