Clinical trial NCT04764162: Choline and Cardiometabolic Health
Official title: Short Term Choline Supplementation and Cardiometabolic Health in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: insulin sensitivity
vascular function
blood pressure
continuous glucose monitoring
trimethylamine N-oxide (TMAO)
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-02-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, placebo-controlled, crossover design
Primary purpose: PREVENTION

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 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 (\<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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Insulin Sensitivity at 4 Weeks
timeFrame: Calculated difference between the baseline and 4-week testing session for each intervention
Secondary outcomes:
measure: Change in 24-hour Area Under the Curve for Glucose Levels After Supplementation
timeFrame: Difference in 24-hour glucose levels during free living at baseline and 4 weeks
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Polytechnic and State University
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute & State University
name: Kevin Davy, PhD
role: PRINCIPAL_INVESTIGATOR
References: