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NCT03327805 · ClinicalTrials.gov registry record · NA
Short Term Choline and Cardiovascular Health
A NA study, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03327805: Completed NA study, sponsored by Virginia Polytechnic Institute and State University.
NCT03327805 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03327805, a NA study, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 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 short term supplementation of dietary choline, which increase 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 once at baseline and then once after each 5-day period of the randomly-assigned supplement (choline or placebo), including
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Choline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-05-08 |
| Est. Completion | 2023-11-21 |
| Phase | NA |
What the finished NCT03327805 record still lists
NCT03327805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03327805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03327805 about?
NCT03327805 is a clinical study titled "Short Term Choline 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 NCT03327805?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2019-05-08. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT03327805?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Choline (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03327805?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03327805's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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