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

Not Applicable

Completed

• Conditions: Diabetes; Coronary Artery Disease; Metabolic Syndrome
• Interventions: Other: Eggs

• Registration Number: NCT03877003
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Primary Completion: 2019-12-14
• Study Completion: 2020-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Egg Intake	Eggs	Consumption of 3 eggs per day for breakfast during 4 weeks
Choline Supplement Intake	Eggs	Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.	1 year	All microorganisms are assayed simultaneously

Trial Locations

Locations (2)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States

Department of Nutritional Sciences; 🇺🇸 Storrs, Connecticut, United States