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Completed

NCT Number: NCT03646175

Choline Supplementation 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 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.

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Key information

Conditions

Cardiovascular Risk Factor

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Polytechnic and State University

Blacksburg, Virginia, 24060, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in brachial artery function after supplementation

    Time frame: 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 outcomes

  1. Change in arterial stiffness after supplementation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

Acute Choline Supplementation and Cardiovascular Health in Adults

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Aug 24, 2018
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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