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NCT03646175 · ClinicalTrials.gov registry record · NA

Choline Supplementation and Cardiovascular Health

A NA study, sponsored by Virginia Polytechnic Institute and State University.

Completed
Registry status
NA
Development phase
29
Enrollment target

NCT03646175: Completed NA study, sponsored by Virginia Polytechnic Institute and State University.

NCT03646175 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03646175, a NA study, has completed, sponsored by Virginia Polytechnic Institute and State University.

COMPLETED
Registry status
NA
Development phase
29 participants
Enrollment target

Study 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 acute supplementation of dietary choline, which increases TMAO, impairs vascular function.

Primary Outcome

Brachial artery function or flow mediated dilation (FMD), the blood flow and diameter of the brachial artery in the forearm (fMD), will be measured using a duplex ultrasound machine before and after the inflation of a blood pressure cuff on the forearm for 5 minutes and after placing a nitroglycerine tablet (0.4 mg) under the participant's tongue. This test will be conducted two times separated by about 1 week. The participant will be randomly-assigned to a supplement (choline or placebo) follow

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Choline

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2018-09-24
Est. Completion 2023-11-21
Phase NA

What the finished NCT03646175 record still lists

NCT03646175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03646175 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03646175 about?

NCT03646175 is a clinical study titled "Choline Supplementation and Cardiovascular Health". 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 obs...

What is the current status of trial NCT03646175?

This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2018-09-24. Estimated completion is 2023-11-21.

What interventions are being tested in trial NCT03646175?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Choline (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03646175?

This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03646175's enrollment target sits among peer trials

29 1702nd of 2000 higher than 297 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03646175, the US trial registry maintained by the National Library of Medicine. NCT03646175 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.