Status:

COMPLETED

Short Term Choline and Cardiovascular Health

Lead Sponsor:

Virginia Polytechnic Institute and State University

Conditions:

Cardiovascular Risk Factor

Eligibility:

All Genders

18-65 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

  • 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

  • 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

Key Trial Info

Start Date :

May 8 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 21 2023

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03327805

Start Date

May 8 2019

End Date

November 21 2023

Last Update

March 21 2025

Active Locations (1)

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Virginia Polytechnic and State University

Blacksburg, Virginia, United States, 24061