NCT04764162

Choline and Cardiometabolic Health

Completed NA Results posted Last updated 31 May 2025

What this trial tests

NA trial testing Choline in Cardiovascular Risk Factor in 14 participants. Completed in 21 November 2023.

Timeline

20 August 2021

Primary endpoint
2 December 2022

21 November 2023

Quick facts

Lead sponsor	Virginia Polytechnic Institute and State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	14
Start date	20 August 2021
Primary completion	2 December 2022
Estimated completion	21 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Choline (Choline) — full drug profile →
• Placebo

Conditions studied

• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

Virginia Polytechnic Institute and State University

Who can join

Adults 18 to 79, any sex, with Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Insulin Sensitivity at 4 Weeks Primary · Calculated difference between the baseline and 4-week testing session for each intervention

Participants will complete a 2-hour glucose tolerance test at baseline, immediately following the first intervention, after a 2-week washout, and immediately following the second intervention. A catheter will be placed in one of the participant's arms. After a baseline blood draw to measure fasting levels of glucose, insulin, cholesterol and other factors, participants will drink a glucose beverage (75 g). Blood will be collected in small amounts (less than one half teaspoon) at eight timepoints over a 2-hour period. Insulin sensitivity will be calculated using Matsuda's index (a ratio with no

Group	Value	95% CI
Choline	0.28	± 0.8
Placebo	-0.29	± 0.45

Change in 24-hour Area Under the Curve for Glucose Levels After Supplementation Secondary · Difference in 24-hour glucose levels during free living at baseline and 4 weeks

Glucose will be monitored by a Continuous Glucose Monitor (CGM) sensor (Enlite Sensor; Medtronic, Inc. or FreeStyle Libre Pro; Abbott) and this will be placed on the participant's abdomen or back of the upper arm in order to measure glucose continuously. The measured glucose levels will be assessed by an iPro2 Professional CGM; Medtronic, Inc. or FreeStyle Libre Pro reader; Abbott; and the CGM will be worn for 4 consecutive days. This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).

Group	Value	95% CI
Choline	7032.5	± 10709.5
Placebo	-2685	± 17213.2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.