Short Term Choline and Cardiovascular Health

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    34
  • sponsor
    Virginia Polytechnic Institute and State University
Updated on 16 March 2022
atherosclerosis
cardiovascular disease
trimethylamine n-oxide
Accepts healthy volunteers

Summary

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 short term supplementation of dietary choline, which increase TMAO, impairs vascular function.

Details
Condition Cardiovascular Risk Factor
Treatment Placebo, Choline
Clinical Study IdentifierNCT03327805
SponsorVirginia Polytechnic Institute and State University
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

-65 years old, healthy, non-smoking 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

Smoking, pregnancy, obese (BMI>35 kg/m^2), altered dietary patterns within the last month of recruitment, vegetarians, vegans, unstable heart disease or diabetes, untreated high blood pressure or high cholesterol, allergies to choline supplement, taking any medications that could affect the results (ex., aspirin, antibiotics, pre/probiotics 1 month prior to enrollment), those with trimethylaminuria
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