Choline Supplementation and Cardiovascular Health

NCT03646175 | Completed

• 1 other identifier: 17-562
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Keywords

Choline; Trimethylamine N-Oxide; Vascular health

Outcome Measures

Primary Outcomes (1)

• Change in brachial artery function after supplementation

  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.).

  30-minute measurement in laboratory

Secondary Outcomes (1)

• Change in arterial stiffness after supplementation

  45-minute measurement in laboratory

Study Arms (2)

Acute Choline Supplementation

EXPERIMENTAL

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

Dietary Supplement: Choline

Placebo Supplementation

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Choline DIETARY_SUPPLEMENT

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.

Acute Choline Supplementation

Placebo DIETARY_SUPPLEMENT

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.

Placebo Supplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Polytechnic and State University

Blacksburg, Virginia, 24060, United States

Location

MeSH Terms

Interventions

Choline

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Kevin Davy, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 24, 2018
• Study Start: September 24, 2018
• Primary Completion: December 2, 2022
• Study Completion: November 21, 2023
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)