Choline and Cardiometabolic Health

NCT ID: NCT04764162

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• 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 short term supplementation of dietary choline, which increases TMAO, affects CVD risk factors, such as glucose homeostasis and vascular function.

Conditions

Cardiovascular Risk Factor

Study Design

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

Study Groups

Choline, then Placebo

Participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions.

Group Type: EXPERIMENTAL

Choline

Intervention Type: DIETARY_SUPPLEMENT

1000 mg (2 x 500 mg) choline bitartrate capsules (over-the-counter supplement)

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Choline-matched 1000 mg (2 x 500 mg) placebo (maltodextrin) capsules

Placebo, then Choline

Participants will consume 1000 mg (2 x 500 mg) of placebo per day for 4 weeks, including post-testing sessions. A 2-week washout period will follow the first intervention. Then the participants will consume 1000 mg (2 x 500 mg) of choline supplement per day for 4 weeks, including post-testing sessions.

Group Type: EXPERIMENTAL

Choline

Intervention Type: DIETARY_SUPPLEMENT

1000 mg (2 x 500 mg) choline bitartrate capsules (over-the-counter supplement)

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Choline-matched 1000 mg (2 x 500 mg) placebo (maltodextrin) capsules

Interventions

Choline

1000 mg (2 x 500 mg) choline bitartrate capsules (over-the-counter supplement)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Choline-matched 1000 mg (2 x 500 mg) placebo (maltodextrin) capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age 18-79 years
• Weight stable for previous 6 months (+2.0kg)
• Sedentary to recreationally active (<30 min aerobic exercise <2x/wk)
• No plans to gain/lose weight or change physical activity level
• Verbal and written informed consent
• Willing to be randomized to treatment order
• Fully vaccinated against COVID-19

Exclusion Criteria

• BMI > 35 kg/m2
• Smoking
• Pregnant or plans of becoming pregnant
• Vegetarian or Vegan
• Changed dietary patterns within the last month
• Diabetes (or use of diabetes medications) or unstable heart disease
• Untreated high blood pressure or high cholesterol
• Health problems that mide it unsafe to participate
• Taking medications, vitamins or supplements that could affect study outcomes (including but not limited to aspirin, antibiotics, prebiotics, and probiotics)
• Known allergy, hypersensitivity, intolerance to choline supplement or its ingredients
• Trimethylaminuria or "fish odor" syndrome

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

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 & State University

Locations

Virginia Polytechnic and State University

Blacksburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AG067380

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-521

Identifier Type: -

Identifier Source: org_study_id