Back to resultsPlasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
Primary Purpose
Coronary Artery Disease, Diabetes, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eggs
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring eggs,, choline, metabolic syndrome, TMAO
Eligibility 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
Sites / Locations
- Department of Nutritional Sciences
- University of Connecticut
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Egg Intake
Choline Supplement Intake
Arm Description
Consumption of 3 eggs per day for breakfast during 4 weeks
Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks
Outcomes
Primary Outcome Measures
Plasma choline and TMAO (micromol/L)
They will be measured simultaneously by use of a mass spectrophotometer
Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
They will be measured simultaneoulsy by use of an automated spectrophotometer
Secondary Outcome Measures
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.
All microorganisms are assayed simultaneously
Full Information
NCT ID
NCT03877003
First Posted
March 13, 2019
Last Updated
November 2, 2020
Sponsor
University of Connecticut
Collaborators
American Egg Board
1. Study Identification
Unique Protocol Identification Number
NCT03877003
Brief Title
Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
Official Title
Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 14, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
American Egg Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes, Metabolic Syndrome
Keywords
eggs,, choline, metabolic syndrome, TMAO
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Egg Intake
Arm Type
Experimental
Arm Description
Consumption of 3 eggs per day for breakfast during 4 weeks
Arm Title
Choline Supplement Intake
Arm Type
Experimental
Arm Description
Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks
Intervention Type
Other
Intervention Name(s)
Eggs
Other Intervention Name(s)
Dietary supplement (choline bitartrate)
Intervention Description
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
Primary Outcome Measure Information:
Title
Plasma choline and TMAO (micromol/L)
Description
They will be measured simultaneously by use of a mass spectrophotometer
Time Frame
1 year
Title
Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
Description
They will be measured simultaneoulsy by use of an automated spectrophotometer
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.
Description
All microorganisms are assayed simultaneously
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Department of Nutritional Sciences
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
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