Skip to main content
Clinical Trials/NCT01906554
NCT01906554
Completed
Not Applicable

Determining Whether or Not Egg Ingestion Increases Concentrations of Trimethylamine N-oxide (TMAO) in Plasma and Urine and Activates LDL Oxidation in Humans

University of North Carolina, Chapel Hill1 site in 1 country6 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Biomarkers of Cardiovascular Disease
Sponsor
University of North Carolina, Chapel Hill
Enrollment
6
Locations
1
Primary Endpoint
Area under the plasma concentration versus time curve (AUC) of TMAO
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Eggs contain an essential nutrient called choline and adequate levels of choline are required for good health. Studies in mice have demonstrated that high levels of choline may increase risk of heart disease through a process that involves the breakdown of choline by gut bacteria. Previous research did not show that human consumption of eggs increases risk of heart disease. This study is designed to investigate whether the number of eggs in the diet affects blood and urine markers for heart disease.

Detailed Description

Diets low in choline have adverse health consequences, while observations in humans and experiments in mouse models suggest that a diet containing too much choline or phosphatidylcholine may activate inflammatory pathways and increase cardiovascular disease risk through bacterial conversion of choline to trimethylamine (TMA) and its subsequent oxidation to trimethylamine N-oxide (TMAO) in the liver. What is unclear is whether choline and phosphatidylcholine in eggs is a source of TMAO formation, and if so how many eggs must be eaten before enough TMAO is generated to cause increased oxidized LDL (a biomarker for atherosclerosis mechanisms). We hypothesize that TMAO will only be formed from eggs when very large quantities are ingested and that TMAO formation will vary greatly between individuals for any given dietary exposure. This variability will be determined by 1) the dose at which dietary choline or phosphatidylcholine exceeds the absorptive capacity of the volunteer's small intestine and therefore spills into large intestine where gut bacteria have access to it and 2) the bacterial populations that constitute the volunteer's microbiome.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven Zeisel

Professor of Nutrition and Pediatrics, Director, UNC Nutrition Research Institute

University of North Carolina, Chapel Hill

Eligibility Criteria

Inclusion Criteria

  • non-smoker
  • Body mass index between 20 to 39 kg/m²

Exclusion Criteria

  • History of chronic system disease/s (e.g., hepatic, renal, cardiovascular, intestinal)
  • Diabetes controlled by insulin
  • Alcohol or illegal drug misuse/abuse
  • Use of antibiotics or choline-containing supplements within three months of study
  • Allergies to soy, eggs, wheat or other food
  • Use of drugs or medications known to alter liver metabolism, cardiovascular and/or kidney function
  • Abnormal physical examination or abnormal clinical laboratory values
  • Pregnancy
  • Unusual dietary habits

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC) of TMAO

Time Frame: TMAO concentrations in plasma collected prior to and 1, 2, 6, 8, and 24 hours after egg ingestion.

Secondary Outcomes

  • Concentration of TMAO in urine(Concentration of TMAO will be measured in 24 hour urine collections that start the morning of the egg dose)

Study Sites (1)

Loading locations...

Similar Trials