Short Term Choline and Cardiovascular Health
Completed · Not applicable · Has a placebo group
Conditions studied: Cardiovascular Risk Factor
In brief
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.
Key facts
- Study ID
- NCT03327805
- Run by
- Virginia Polytechnic Institute and State University
- People needed
- 20
- Starts
- 2019-05-08
- Expected to finish
- 2023-11-21
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18-65 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.)
You may not qualify if…
- 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
Where it is running
- Virginia Polytechnic and State University — Blacksburg, Virginia, United States
Full record on ClinicalTrials.gov
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