Choline and Cardiometabolic Health

  • STATUS
    Recruiting
  • days left to enroll
    77
  • participants needed
    60
  • sponsor
    Virginia Polytechnic Institute and State University
Updated on 18 April 2022
Accepts healthy volunteers

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.

Details
Condition Cardiovascular Risk Factor
Treatment Placebo Capsule, Choline capsule
Clinical Study IdentifierNCT04764162
SponsorVirginia Polytechnic Institute and State University
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

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
Fully vaccinated against COVID-19
Willing to be randomized to treatment order

Exclusion Criteria

BMI > 35 kg/m2
Smoking
Changed dieatry 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
Vegetarian or Vegan
Trimethylaminuria or "fish odor" syndrome
Pregnant or plans of becoming pregnant
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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