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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
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 will test whether a metabolite produced by gut microbial metabolism of dietary choline (TMAO) affects vascular function in humans.

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
Arterial Stiffness

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: Acute Choline SupplementationExperimental Treatment1 Intervention
Participants will consume 1000 mg (2x500 mg) of choline bitartrate the evening before each testing session.
Group II: Placebo SupplementationPlacebo Group1 Intervention
Participants will consume 1000 mg (2x500 mg) of placebo the evening before each testing session.
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
27,737 Total Patients Enrolled
3 Trials studying Cardiovascular Risk
47 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
89 Total Patients Enrolled
3 Trials studying Cardiovascular Risk
47 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 qualifying criteria for enrollment in this trial?

"Criteria for inclusion in this experiment necessitates that the patient has a cardiovascular risk profile and is aged between 18-65. The total number of participants being accepted into this trial is 12."

Answered by AI

How many individuals have volunteered to partake in this research project?

"Yes, clinicaltrials.gov verifies that this medical trial is actively enrolling patients. Its initial posting was on September 24th 2018 and it has been updated as recently as October 4th 2022. The research team seeks 12 individuals from a single centre for the study's duration."

Answered by AI

Are new participants being enrolled in this experiment?

"Clinicaltrials.gov divulges that this clinical trial is actively recruiting patients. It was first published on September 24th 2018 and updated most recently in October 4th 2022."

Answered by AI

Does this research encompass those aged 18 and above?

"This trial is seeking participants that fall between 18 years old and 65 years old."

Answered by AI
~4 spots leftby Apr 2025