NCT04764162

Choline and Cardiometabolic Health

Short Term Choline Supplementation and Cardiometabolic Health in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 18 Years – 79 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 increases TMAO, affects CVD risk factors, such as glucose homeostasis and vascular function.

Conditions

• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Choline	1000 mg (2 x 500 mg) choline bitartrate capsules (over-the-counter supplement)
DIETARY_SUPPLEMENT	Placebo	Choline-matched 1000 mg (2 x 500 mg) placebo (maltodextrin) capsules

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-12-02
• Completion: 2023-11-21
• First posted: 2021-02-21
• Last updated: 2025-05-31
• Results posted: 2024-11-29

Locations

1 site across 1 country: United States