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

Sponsor

University of Connecticut (Other)

Overall Status

Completed

CT.gov ID

NCT03877003

Collaborator

American Egg Board (Other)

Enrollment

Locations

Arms

19.9

Actual Duration (Months)

12.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Diabetes Metabolic Syndrome	Other: Eggs	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized crossover designRandomized 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 :

Nov 1, 2018

Actual Primary Completion Date :

Dec 14, 2019

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

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 Names: 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 Names: Dietary supplement (choline bitartrate)

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 Names:

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 Names:

Dietary supplement (choline bitartrate)

Outcome Measures

Primary Outcome Measures

Plasma choline and TMAO (micromol/L) [1 year]
They will be measured simultaneously by use of a mass spectrophotometer
Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL [1 year]
They will be measured simultaneoulsy by use of an automated spectrophotometer

Secondary Outcome Measures

Analysis of microbiota diversity (expressed as concentrations of different microorganisms. [1 year]
All microorganisms are assayed simultaneously

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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