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

Study Overview
=================
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.

Official Title
-----------------
Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake

Conditions
-----------------
Coronary Artery Disease, Diabetes, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Eggs


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg Intake<br>Consumption of 3 eggs per day for breakfast during 4 weeks | Other: Eggs<br>* Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks<br>* Other names: Dietary supplement (choline bitartrate);|
| Experimental: Choline Supplement Intake<br>Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks | Other: Eggs<br>* Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks<br>* Other names: Dietary supplement (choline bitartrate);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma choline and TMAO (micromol/L) | They will be measured simultaneously by use of a mass spectrophotometer | 1 year | 
| Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL | 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. | All microorganisms are assayed simultaneously | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eggs,, choline, metabolic syndrome, TMAO