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Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.

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ClinicalTrials.gov Identifier: NCT03877003
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Maria Luz Fernandez, University of Connecticut

Brief Summary:
The objective of this study is to determine the effects of consuming either 3 eggs per day and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. The goal is to determine if choline given as phosphatidyl choline (from eggs) will have a more beneficial effect on plasma choline and microbiota.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Metabolic Syndrome Other: Eggs Not Applicable

Detailed Description:

Epidemiological data suggests that egg intake does not increase the risk for cardiovascular disease (CVD). In fact eggs are a good source of phosphatidyl choline (PC) and choline has a number of metabolic roles including lipid metabolism, membrane structure, liver health and a neurotransmitter. Recent reports that choline may be metabolized by the intestinal microbiota into TMAO, a compound that may increase the risk for heart disease. It is not clear how much egg contribute to TMAO formation in individuals with metabolic syndrome.

Therefore the objective of this study is to determine the impact of daily intake of 3 eggs versus a choline supplement on plasma TMAO and other biomarkers for CVD risk and also to assess if there are changes in microbiota with these interventions that might lead to the increases of TMAO in plasma.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Egg Intake
Consumption of 3 eggs per day for breakfast during 4 weeks
Other: Eggs
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
Other Name: Dietary supplement (choline bitartrate)

Experimental: Choline Supplement Intake
Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks
Other: Eggs
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
Other Name: Dietary supplement (choline bitartrate)




Primary Outcome Measures :
  1. Plasma choline and TMAO (micromol/L) [ Time Frame: 1 year ]
    They will be measured simultaneously by use of a mass spectrophotometer

  2. Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL [ Time Frame: 1 year ]
    They will be measured simultaneoulsy by use of an automated spectrophotometer


Secondary Outcome Measures :
  1. Analysis of microbiota diversity (expressed as concentrations of different microorganisms. [ Time Frame: 1 year ]
    All microorganisms are assayed simultaneously



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All genders
  • 35-70 years
  • Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference > 88 cm for women and > 102 cm for men, plasma triglycerides > 150 mg/dL, fasting glucose > 100 mg/dL, blood pressure > 135/85 and HDL < 40 mg/dL for men and < 50 mg/dL for women),
  • willing to consume 3 eggs per day for 4 weeks
  • willing to consume choline supplement (400 mg/day for 4 weeks)

Exclusion Criteria:

  • Self-reported diaberes, cardiovascular disease, history of stroke, liver disease or cancer
  • Taking glucose lowering medications
  • Taking antibiotics in the previous 1 month
  • Triglycerides > 500 mg/dL,
  • Cholesterol > 240 mg/dL,
  • blood pressure > 145/100 mm of Hg
  • Allergic to eggs or 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): NCT03877003


Contacts
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Contact: Maria-Luz Fernandez, phD 860-486-5547 maria-luz.fernandez@uconn.edu

Locations
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United States, Connecticut
Department of Nutritional Sciences Recruiting
Storrs, Connecticut, United States, 06269
Contact: Maria-Luz Fernandez, PhD    860-486-5547    maria-luz.fernandez@uconn.edu   
Contact: Minu S Thomas, MS       minu.thomas@uconn.edu   
University of Connecticut Recruiting
Storrs, Connecticut, United States, 06269
Contact: Maria-Luz Fernandez, Phd    860-486-5547    maria-luz.fernandez@uconn.edu   
Principal Investigator: Maria Luz Fernandez, PhD         
Sponsors and Collaborators
University of Connecticut
American Egg Board

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Responsible Party: Maria Luz Fernandez, Principal Investigator, University of Connecticut
ClinicalTrials.gov Identifier: NCT03877003     History of Changes
Other Study ID Numbers: H18-126
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 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 Maria Luz Fernandez, University of Connecticut:
eggs,
choline
metabolic syndrome
TMAO

Additional relevant MeSH terms:
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Cardiovascular Diseases
Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Metabolic Syndrome
Disease
Pathologic Processes
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents