Status:
COMPLETED
Choline and Cardiometabolic Health
Lead Sponsor:
Virginia Polytechnic Institute and State University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Cardiovascular Risk Factor
Eligibility:
All Genders
18-79 years
Phase:
NA
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 pred...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04764162
Start Date
August 20 2021
End Date
November 21 2023
Last Update
May 31 2025
Active Locations (1)
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1
Virginia Polytechnic and State University
Blacksburg, Virginia, United States, 24060