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Choline for Cardiovascular Risk

N/A
Waitlist Available
Led By Kevin Davy, PhD
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years old, healthy, non-smoking weight stable for previous 6 months (±2.0 kg), BMI<35 kg/m^2, verbal and written informed consent, approved for participation by study medical director (Jose Rivero, M.D.)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45-minute measurement in laboratory
Awards & highlights

Study Summary

This trial is studying how well trimethylamine-N-oxide (TMAO) works in improving vascular function in people with stable cardiovascular disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45-minute measurement in laboratory
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45-minute measurement in laboratory for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in brachial artery function after supplementation
Secondary outcome measures
Change in arterial stiffness after supplementation
Change in gut-mediated TMAO levels after supplementation

Side effects data

From 2014 Phase 4 trial • 60 Patients • NCT01749982
13%
Diarrhea
13%
Fever
7%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Choline Bitartrate
Betaine
Choline Bitartrate + Betaine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Short Term Choline SupplementationExperimental Treatment1 Intervention
Participants will be asked to consume 1000 mg of choline bitartrate for 4 weeks prior to and during the testing period.
Group II: Short Term Placebo SupplementationPlacebo Group1 Intervention
Participants will be asked to consume 1000 mg of placebo (maltodextrin) for 4 weeks prior to and during the testing period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Choline
2015
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityLead Sponsor
141 Previous Clinical Trials
27,746 Total Patients Enrolled
3 Trials studying Cardiovascular Risk
56 Patients Enrolled for Cardiovascular Risk
Kevin Davy, PhDPrincipal Investigator - Virginia Polytechnic Institute and State University
Virginia Polytechnic Institute and State University
4 Previous Clinical Trials
98 Total Patients Enrolled
3 Trials studying Cardiovascular Risk
56 Patients Enrolled for Cardiovascular Risk

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this trial for enrollees?

"Affirmative. Clinicaltrials.gov indicates that this investigation is currently recruiting candidates, having first been posted on April 1st 2019 and last updated August 15th 2022. It aims to enrol 34 patients in a single site."

Answered by AI

Are participants over the age of 35 eligible to partake in this trial?

"The primary trial is seeking patient aged 18 to 65, however there are 3 additional studies for minors and 66 more suitable trials for seniors."

Answered by AI

What is the current enrollment limit for this experiment?

"Affirmative. According to clinicaltrials.gov, this research project is currently recruiting participants; the first posting was on April 1st 2019 and it was recently updated on August 15th 2022. At present, 34 patients are requested from a single medical site."

Answered by AI

Is there any possibility for me to take part in this experiment?

"This medical trial has a participant quota of 34 individuals eligible by virtue of having cardiovascular risk and being between 18-65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Short Term Choline and Cardiovascular Health
Kevin Davy 2019. "Short Term Choline and Cardiovascular Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03327805.
~3 spots leftby Apr 2025
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