Assessment of TMAO Formation With Egg Intake Versus Choline Supplement in a Healthy Population

January 4, 2019 updated by: Maria Luz Fernandez, University of Connecticut
The objective of this study is to determine the effects of consuming either 3 eggs per day as compared to a daily choline supplement (choline bitartrate, 397.5 mg choline/day) on plasma concentrations of High Density Lipoprotein-cholesterol (HDL-C), trimethylamine N-oxide (TMAO), and other biomarkers of cardiovascular disease risk in young, healthy individuals. The goal is to determine if choline given as phosphatidylcholine (eggs) will lead to a different TMAO response when compared to choline in free supplemental form.

Study Overview

Status

Completed

Detailed Description

Epidemiological data in short term studies, suggests that egg intake does not increase risk for cardiovascular disease (CVD). In fact, eggs are a great source of phospholipids (phosphatidylcholine) where choline has many metabolic roles, specially in lipid metabolism and cell membrane structure. Choline is present in the diet as free choline, which is absorbed in the small intestines, or choline esters, which is absorbed intact primarily through the lymphatic system. In addition, recent evidence suggests that the choline found in eggs may be metabolized by intestinal microbes into trimethylamine N-oxide (TMAO), a compound that may increase the risk for CVD. However, it is not known to what extent egg intake may contribute to plasma TMAO concentrations.

Therefore, the objective of this study is to determine the impacts of daily intake of 3 eggs versus a choline supplement on plasma TMAO as well as other biomarkers for CVD risk, with the goal of determining if the same amount of choline given as phosphatidylcholine from eggs will increase plasma choline levels without a concomitant increase in plasma TMAO, such that CVD risk is not negatively impacted.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • Storrs, Connecticut, United States, 06269
        • University of Connecticut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women (18-30 years), BMI 18.5 - 29.9 kg/m2, proficient in English, and willing to consume 3 eggs per day or 397.5 mg of choline supplement (1½ tablets/day) for 4 weeks each.

Exclusion Criteria:

  • Self-reported diabetes mellitus, cardiovascular disease, history of stroke, renal problems, liver disease, cancer, or a diagnosed eating disorder
  • Taking any glucose-lowering prescriptions or supplements, triglyceride-lowering medications, bile acid sequestrants, or high dose chromium or cinnamon supplements
  • Taken antibiotics in the previous 1 months, or if they are vegetarian or vegan
  • BMI ≤ 18.4 or ≥ 30 kg/m2, or extreme clinical values, such as plasma triglycerides > 500 mg/dL, plasma glucose > 126 mg/dL, plasma cholesterol > 240 mg/dL, plasma creatinine ≤ 0.5 or ≥ 0.9 mg/dL for females and ≤ 0.7 or ≥ 1.2 mg/dL for males, or blood pressure > 140/90 mm Hg (average of 3 readings)
  • Allergic to eggs or any component of the choline supplement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egg intake
Consumption of 3 eggs per day for breakfast, 4 weeks
Consumption of 3 eggs per day for breakfast, 4 weeks
Experimental: Choline Supplement intake
Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks
Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eggs of Egg Consumption on Plasma Biochemical Parameters
Time Frame: 1 year
Using plasma form each participant, an automated spectrophotometer is able to analyze at once plasma lipids [total colesterol, triglycerides, HDL (mg/dL)], glucose (mg/dL), CRP (mg/dL, and liver enzymes [alanine aminotransferase and aspartate aminotransferase (U/L)].
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Intervention on Gene Expression using RT-PCR
Time Frame: 1 year
PBMC will be isolated from whole blood. RNA will be isolated from these cells, and then cDNA will be synthesized using a specific kit. Finally a RT-PCR will be used to analyze the expression of genes, such as: GAPDH, HMG-CoA reductase, LDL-r, CD36, SRA, FMO3, SRB1, PPAR-gama. All results will be presented based on house keeping gene GAPDH.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria Luz Fernandez, PhD, University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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