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Choline and Cardiometabolic Health

NCT04764162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-05-31

Study results available
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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

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Virginia Polytechnic Institute and State University

    lead OTHER

Principal Investigators

  • Kevin Davy, PhD · Virginia Polytechnic Institute & State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2022-12-02
Completion
2023-11-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764162 on ClinicalTrials.gov