Choline Supplementation and Cardiovascular Health

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Choline; Dietary Supplement: Placebo

• Registration Number: NCT03646175
• Lead Sponsor: Virginia Polytechnic Institute and State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-18
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Study Start: 2018-09-24
• Primary Completion: 2022-12-02
• Study Completion: 2023-11-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acute Choline Supplementation	Choline	Participants will consume 1000 mg (2x500 mg) of choline bitartrate the evening before each testing session.
Placebo Supplementation	Placebo	Participants will consume 1000 mg (2x500 mg) of placebo the evening before each testing session.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Virginia Polytechnic and State University; 🇺🇸 Blacksburg, Virginia, United States