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

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University of Connecticut

Status

Completed

Conditions

Coronary Artery Disease
Diabetes
Metabolic Syndrome

Treatments

Other: Eggs

Study type

Interventional

Funder types

Other

Identifiers

NCT03877003
H18-126

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

25 participants in 2 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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