Choline Supplementation and Cardiovascular Health

NCT ID: NCT03646175

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2023-11-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Acute Choline Supplementation

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

Group Type: EXPERIMENTAL

Choline

Intervention Type: 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 Supplementation

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Kevin Davy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Davy, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Virginia Polytechnic and State University

Blacksburg, Virginia, United States

Countries

United States

Other Identifiers

17-562

Identifier Type: -

Identifier Source: org_study_id