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Short Term Choline and Cardiovascular Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327805
Recruitment Status : Suspended (COVID-19 restrictions)
First Posted : October 31, 2017
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Kevin Davy, Virginia Polytechnic Institute and State University

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 increase TMAO, impairs vascular function.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Dietary Supplement: Choline Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind, placebo-controlled, crossover design
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Short Term Choline Supplementation and Cardiovascular Health in Adults
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short Term Choline Supplementation
Participants will be asked to consume 1000 mg of choline bitartrate for 2 weeks prior to and during the testing period.
Dietary Supplement: Choline
Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) for 14 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of choline bitartrate the evening before the third testing session to study its acute effects.

Placebo Comparator: Short Term Placebo Supplementation
Participants will be asked to consume 1000 mg of placebo (maltodextrin) for 2 weeks prior to and during the testing period.
Dietary Supplement: Placebo
Participants will consume 1000 mg (2x500 mg) of placebo for 14 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of placebo the evening before the third testing session to study its acute effects.

Experimental: Acute Choline Supplementation
Participants will be asked to consume 1000 mg of choline bitartrate 8 hours prior to the third testing session at baseline testing.
Dietary Supplement: Choline
Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) for 14 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of choline bitartrate the evening before the third testing session to study its acute effects.

Placebo Comparator: Acute Placebo Supplementation
Participants will be asked to consume 1000 mg of placebo 8 hours prior to the third testing session at baseline testing.
Dietary Supplement: Placebo
Participants will consume 1000 mg (2x500 mg) of placebo for 14 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of placebo the evening before the third testing session to study its acute effects.




Primary Outcome Measures :
  1. Change in brachial artery function after supplementation [ Time Frame: 30-minute measurement in laboratory ]
    Brachial artery function or flow mediated dilation (FMD), the blood flow and diameter of the brachial artery in the forearm (fMD), will be measured using a duplex ultrasound machine before and after the inflation of a blood pressure cuff on the forearm for 5 minutes and after placing a nitroglycerine tablet (0.4 mg) under the participant's tongue. This test will be conducted once at baseline and then once after each 5-day period of the randomly-assigned supplement (choline or placebo), including a 1-week washout period (crossover design). Off-line analysis of baseline and post-reactive hyperemic diameters and velocities will be performed using edge detection software (Vascular Analysis Tools, Medical Imaging Applications, Inc.).


Secondary Outcome Measures :
  1. Change in arterial stiffness after supplementation [ Time Frame: 45-minute measurement in laboratory ]
    The blood flow and diameter in the common arteries in the neck will be measured from the image obtained from an ultrasound unit (GE Vivid S6) equipped with a high resolution linear array transducer. For applanation tonometry, the carotid, brachial, radial and femoral artery pressure waveform and amplitude will be obtained by a fingertip probe incorporating a high-fidelity strain gauge transducer. Each of these measures are used to calculate arterial stiffness. These tests will be conducted once at baseline and then once after each 5-day period of the randomly-assigned supplement (choline or placebo), including a 1-week washout period (crossover design).

  2. Change in gut-mediated TMAO levels after supplementation [ Time Frame: 5-minute measurement in laboratory ]
    At baseline, a fasting blood sample will be collected to measure plasma TMAO concentration after supplementation consumption 8 hours prior to the third testing session.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327805


Locations
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United States, Virginia
Virginia Polytechnic and State University
Blacksburg, Virginia, United States, 24061
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Kevin Davy, PhD Virginia Polytechnic Institute and State University
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Responsible Party: Kevin Davy, Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03327805    
Other Study ID Numbers: 18-535
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin Davy, Virginia Polytechnic Institute and State University:
Choline
Trimethylamine N-Oxide
Vascular health
Additional relevant MeSH terms:
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Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents