- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877003
Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
Storrs, Connecticut, United States, 06269
- Department of Nutritional Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Egg Intake
Consumption of 3 eggs per day for breakfast during 4 weeks
|
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
Other Names:
|
Experimental: Choline Supplement Intake
Consumption of choline supplement 1.5 tablets (approx.
400 mg) with breakfast for 4 weeks
|
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma choline and TMAO (micromol/L)
Time Frame: 1 year
|
They will be measured simultaneously by use of a mass spectrophotometer
|
1 year
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.
Time Frame: 1 year
|
All microorganisms are assayed simultaneously
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Disease
- Insulin Resistance
- Hyperinsulinism
- Coronary Disease
- Coronary Artery Disease
- Syndrome
- Metabolic Syndrome
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Gastrointestinal Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Nootropic Agents
- Lipotropic Agents
- Choline
Other Study ID Numbers
- H18-126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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