Choline Supplementation and Cardiovascular Health

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03646175

Collaborator

(none)

Enrollment

Location

Arms

50.2

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Factor	Dietary Supplement: Choline Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Acute Choline Supplementation and Cardiovascular Health in Adults

Actual Study Start Date :

Sep 24, 2018

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acute Choline Supplementation Participants will consume 1000 mg (2x500 mg) of choline bitartrate the evening before each testing session.	Dietary Supplement: Choline Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.
Placebo Comparator: Placebo Supplementation Participants will consume 1000 mg (2x500 mg) of placebo the evening before each testing session.	Dietary Supplement: Placebo Participants will consume 1000 mg (2x500 mg) of placebo between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.

Arm

Intervention/Treatment

Experimental: Acute Choline Supplementation

Participants will consume 1000 mg (2x500 mg) of choline bitartrate the evening before each testing session.

Dietary Supplement: Choline

Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.

Placebo Comparator: Placebo Supplementation

Participants will consume 1000 mg (2x500 mg) of placebo the evening before each testing session.

Dietary Supplement: Placebo

Participants will consume 1000 mg (2x500 mg) of placebo between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.

Outcome Measures

Primary Outcome Measures

Change in brachial artery function after supplementation [30-minute measurement in laboratory]
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) followed by a 1-week washout period (crossover design). The supplement will be taken with water between 10PM and 12AM the evening before the scheduled testing session. Off-line analysis of baseline and post-reactive hyperemic diameters and velocities will be performed using edge detection software (Vascular Analysis Tools, Medical Imaging Applications, Inc.).

Secondary Outcome Measures

Change in arterial stiffness after supplementation [45-minute measurement in laboratory]
The blood flow and diameter in the common arteries in the neck will be measured from the image obtained from an ultrasound unit (GE Vivid S6) equipped with a high resolution linear array transducer. For applanation tonometry, the carotid, brachial, radial and femoral artery pressure waveform and amplitude will be obtained by a fingertip probe incorporating a high-fidelity strain gauge transducer. Each of these measures are used to calculate arterial stiffness. These tests will be conducted two times separated by about 1 week. The participant will be randomly-assigned to a supplement (choline or placebo) followed by a 1-week washout period (crossover design). The supplement will be taken with water between 10PM and 12AM the evening before the scheduled testing session.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.)

Exclusion Criteria:

Smoking
Pregnancy
Obese (BMI>35 kg/m2)
Altered dietary patterns within the last month of recruitment
Unstable heart disease or diabetes
Untreated high blood pressure or high cholesterol
Allergies to choline
Unvaccinated against COVID-19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Polytechnic and State University	Blacksburg	Virginia	United States	24060

Sponsors and Collaborators

Virginia Polytechnic Institute and State University

Investigators

Principal Investigator: Kevin Davy, PhD, Virginia Polytechnic Institute and State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kevin Davy, Professor, Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT03646175

Other Study ID Numbers:

17-562

First Posted:

Aug 24, 2018

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kevin Davy, Professor, Virginia Polytechnic Institute and State University

Choline

Trimethylamine N-Oxide

Vascular health

Additional relevant MeSH terms:

Choline

Study Results

No Results Posted as of Apr 7, 2022