N/A
N=10
Choline and Cardiometabolic Health
Cardiovascular Risk Factor
Bottom Line
View on ClinicalTrials.gov: NCT04764162 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change From Baseline in Insulin Sensitivity at 4 Weeks — 0.28; -0.29 Calculated Ratio - No units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Choline (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insulin Sensitivity at 4 Weeks |
0.28; -0.29 | — |
| SECONDARY Change in 24-hour Area Under the Curve for Glucose Levels After Supplementation |
7032.5; -2685 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-79 years
- Weight stable for previous 6 months (+2.0kg)
- Sedentary to recreationally active ( 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
Data sourced from ClinicalTrials.gov (NCT04764162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.