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Completed

NCT Number: NCT03877003

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

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Sciences, Storrs, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eggs

Other

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)

Primary outcomes

  1. Plasma choline and TMAO (micromol/L)

    Time frame: 1 year

    They will be measured simultaneously by use of a mass spectrophotometer

  2. Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL

    Time frame: 1 year

    They will be measured simultaneoulsy by use of an automated spectrophotometer

Secondary outcomes

  1. Analysis of microbiota diversity (expressed as concentrations of different microorganisms.

    Time frame: 1 year

    All microorganisms are assayed simultaneously

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • American Egg Board

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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