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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877003
• Other study ID #: H18-126
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2020
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes
• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Eggs
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks

Locations

Country	Name	City	State
United States	Department of Nutritional Sciences	Storrs	Connecticut
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	American Egg Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma choline and TMAO (micromol/L)	They will be measured simultaneously by use of a mass spectrophotometer	1 year
Primary	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	Analysis of microbiota diversity (expressed as concentrations of different microorganisms.	All microorganisms are assayed simultaneously	1 year