NCT03327805

Short Term Choline and Cardiovascular Health

Short Term Choline Supplementation and Cardiovascular Health in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Choline	Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) for 28 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of choline bitartrate the evening before the third testing session to study its acute effects.
DIETARY_SUPPLEMENT	Placebo	Participants will consume 1000 mg (2x500 mg) of placebo for 28 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of placebo the evening before the third testing session to study its acute effects.

Timeline

• Start date: 2019-05-08
• Primary completion: 2022-12-02
• Completion: 2023-11-21
• First posted: 2017-10-31
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States