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

NCT ID: NCT03877003

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Diabetes Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized crossover design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Egg Intake

Consumption of 3 eggs per day for breakfast during 4 weeks

Group Type EXPERIMENTAL

Eggs

Intervention Type OTHER

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

Choline Supplement Intake

Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks

Group Type EXPERIMENTAL

Eggs

Intervention Type OTHER

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

Interventions

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Eggs

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

Intervention Type OTHER

Other Intervention Names

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Dietary supplement (choline bitartrate)

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Egg Board

OTHER

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Maria Luz Fernandez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nutritional Sciences

Storrs, Connecticut, United States

Site Status

University of Connecticut

Storrs, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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H18-126

Identifier Type: -

Identifier Source: org_study_id