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Completed

NCT Number: NCT04764162

Choline and Cardiometabolic Health

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.

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Key information

Conditions

Cardiovascular Risk Factor Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Polytechnic and State University

Blacksburg, Virginia, 24060, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choline

Dietary Supplement

1000 mg (2 x 500 mg) choline bitartrate capsules (over-the-counter supplement)

Placebo

Dietary Supplement

Choline-matched 1000 mg (2 x 500 mg) placebo (maltodextrin) capsules

Primary outcomes

  1. Change From Baseline in Insulin Sensitivity at 4 Weeks

    Time frame: Calculated difference between the baseline and 4-week testing session for each intervention

    Participants will complete a 2-hour glucose tolerance test at baseline, immediately following the first intervention, after a 2-week washout, and immediately following the second 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 2-hour period. Insulin sensitivity will be calculated using Matsuda's index (a ratio with no units). This test will be conducted two times separated by about 4 weeks for each intervention (choline, placebo).

Secondary outcomes

  1. Change in 24-hour Area Under the Curve for Glucose Levels After Supplementation

    Time frame: Difference in 24-hour glucose levels during free living at baseline and 4 weeks

    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).

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Short Term Choline Supplementation and Cardiometabolic Health in Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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