CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Choline +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04764162
NCT04764162N/ACompleted

Short Term Choline Supplementation and Cardiometabolic Health in Adults

Virginia Polytechnic Institute and State University·interventional·Posted Feb 21, 2021·Updated May 31, 2025

In Brief

A clinical study evaluating Choline and Placebo for Cardiovascular Risk Factor. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartAug 20, 2021
Primary CompletionDec 2, 2022
Study CompletionNov 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.4 years ago

Interventions

Cholinedietary

1000 mg (2 x 500 mg) choline bitartrate capsules (over-the-counter supplement)

Placebodietary

Choline-matched 1000 mg (2 x 500 mg) placebo (maltodextrin) capsules