Choline and Cardiometabolic Health

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Dietary Supplement: Choline; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04764162

R21AG067380 (U.S. NIH Grant/Contract)

25-521

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 increases TMAO, affects CVD risk factors, such as glucose homeostasis and vascular function.

Enrollment: 14 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Choline, then Placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Choline

Placebo, then Choline

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Choline