Choline and Cardiometabolic Health

Cardiovascular Risk Factor Clinical Trial

Official title:

Short Term Choline Supplementation and Cardiometabolic Health in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764162
• Other study ID #: VT18-535-568(TRX)
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: November 21, 2023

Study information

• Verified date: February 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 21, 2023
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 dieatry 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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• Choline capsule
Participants will consume 1000 mg (2 x 500 mg) of choline bitartrate (over-the-counter supplement) for 28 consecutive days. They will continue to consume 1000 mg of choline bitartrate during the post-testing period.
• Placebo capsule
Participants will consume 1000 mg (2 x 500 mg) of placebo (maltodextrin) for 28 consecutive days. They will continue to consume 1000 mg of placebo during the post-testing period.

Locations

Country	Name	City	State
United States	Virginia Polytechnic and State University	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insulin Sensitivity after Supplementation	Participants will complete a slucose tolerance test at baseline, after a 2-week washout, and immediately following each intervention. A catheter will be placed in one of the participant's arms. After a baseline blood draw to measure fasting levels of glucose, insulin, cholesterol and other factors, participants will drink a glucose beverage (75 g). Blood will be collected in small amounts (less than one half teaspoon) at eight timepoints over a three-hour period. Insulin sensivity will be calculated using Matsuda's index. This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).	3-hour test in laboratory at 4 timepoints; baseline, week 4, week 6, and week 10
Secondary	Change in 24-hour Area Under the Curve for Glucose Levels after Supplementation	Glucose will be monitored by a Continuous Glucose Monitor (CGM) sensor (Enlite Sensor; Medtronic, Inc. or FreeStyle Libre Pro; Abbott) and this will be placed on the participant's abdomen or back of the upper arm in order to measure glucose continuously. The measured glucose levels will be assessed by an iPro2 Professional CGM; Medtronic, Inc. or FreeStyle Libre Pro reader; Abbott; and the CGM will be worn for 4 consecutive days. This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).	4-day measurement during free living