Short Term Choline Supplementation and Cardiovascular Health in Adults
| Registry | NCT03327805 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, prevention |
| Enrollment | 20 (Actual) |
| Sponsor | Virginia Polytechnic Institute and State University (Other) |
| Conditions | Cardiovascular Risk Factor |
| Interventions | Choline, Placebo (Dietary supplement) |
| Dates | start 2019-05-08, primary completion 2022-12-02, completion 2023-11-21, first posted 2017-10-31, last updated 2026-03-27 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Cardiovascular Risk Factor All trials of Choline All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Short Term Choline Supplementation | Experimental | Dietary Supplement: Choline | Participants will be asked to consume 1000 mg of choline bitartrate for 4 weeks prior to and during the testing period. |
| Short Term Placebo Supplementation | Placebo comparator | Dietary Supplement: Placebo | Participants will be asked to consume 1000 mg of placebo (maltodextrin) for 4 weeks prior to and during the testing period. |
Sex: All, ages: 18 Years to 65 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| Virginia Polytechnic and State University | Blacksburg, Virginia | United States |