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Choline Supplementation and Cardiovascular Health

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ClinicalTrials.gov Identifier: NCT03646175
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : April 4, 2019
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 acute supplementation of dietary choline, which increases 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 : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Acute Choline Supplementation and Cardiovascular Health in Adults
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : April 2, 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acute Choline Supplementation
Participants will consume 1000 mg (2x500 mg) of choline bitartrate the evening before each testing session.
Dietary Supplement: Choline
Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.

Placebo Comparator: Placebo Supplementation
Participants will consume 1000 mg (2x500 mg) of placebo the evening before each testing session.
Dietary Supplement: Placebo
Participants will consume 1000 mg (2x500 mg) of placebo between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.




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 two times separated by about 1 week. The participant will be randomly-assigned to a supplement (choline or placebo) followed by a 1-week washout period (crossover design). The supplement will be taken with water between 10PM and 12AM the evening before the scheduled testing session. 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 two times separated by about 1 week. The participant will be randomly-assigned to a supplement (choline or placebo) followed by a 1-week washout period (crossover design). The supplement will be taken with water between 10PM and 12AM the evening before the scheduled testing session.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-60 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/m2)
  • Altered dietary patterns within the last month of recruitment
  • Unstable heart disease or diabetes
  • Untreated high blood pressure or high cholesterol
  • Allergies to choline

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): NCT03646175


Contacts
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Contact: Kevin Davy, PhD 540-231-3487 kdavy@vt.edu
Contact: Elaina Marinik, PhD 540-231-0923 emarinik@vt.edu

Locations
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United States, Virginia
Virginia Polytechnic and State University Recruiting
Blacksburg, Virginia, United States, 24060
Contact: Kevin Davy, PhD    540-231-3487    kdavy@vt.edu   
Contact: Elaina Marinik, PhD    540-231-0923    emarinik@vt.edu   
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: NCT03646175     History of Changes
Other Study ID Numbers: 17-562
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
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