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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes; Metabolic Syndrome
• Intervention / Treatment: Other: Eggs

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut
    • Storrs, Connecticut, United States, 06269
      • Department of Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Egg Intake; Consumption of 3 eggs per day for breakfast during 4 weeks	Other: Eggs; 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)
Experimental: Choline Supplement Intake; Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks	Other: Eggs; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma choline and TMAO (micromol/L)	They will be measured simultaneously by use of a mass spectrophotometer	1 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.	All microorganisms are assayed simultaneously	1 year

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: American Egg Board

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 14, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: metabolic syndrome; choline; TMAO; eggs,
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Insulin Resistance; Hyperinsulinism; Coronary Disease; Coronary Artery Disease; Syndrome; Metabolic Syndrome; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: H18-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No