Short Term Choline and Cardiovascular Health

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Choline

Study type: Interventional

Funder types: Other

Identifiers

NCT03327805

18-535

Details and patient eligibility

About

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 increase TMAO, impairs vascular function.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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/m^2), altered dietary patterns within the last month of recruitment, vegetarians, vegans, unstable heart disease or diabetes, untreated high blood pressure or high cholesterol, allergies to choline supplement, taking any medications that could affect the results (ex., aspirin, antibiotics, pre/probiotics 1 month prior to enrollment), those with trimethylaminuria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Short Term Choline Supplementation

Experimental group

Description:

Participants will be asked to consume 1000 mg of choline bitartrate for 4 weeks prior to and during the testing period.

Treatment:

Dietary Supplement: Choline

Short Term Placebo Supplementation

Placebo Comparator group

Description:

Participants will be asked to consume 1000 mg of placebo (maltodextrin) for 4 weeks prior to and during the testing period.

Treatment:

Dietary Supplement: Placebo