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OpenTrials
Completed

NCT Number: NCT01906554

Plasma and Urine TMAO Formation and Changes to Oxidized LDL After Ingestion of Different Amounts of Egg

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy
  • 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

Treatment and study plan

Egg Dose

Other

Different quantities of eggs

Primary outcomes

  1. 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

  1. Concentration of TMAO in urine

    Time frame: Concentration of TMAO will be measured in 24 hour urine collections that start the morning of the egg dose

Other outcomes

  1. Changes to plasma oxidized LDL

    Time frame: Oxidized LDL will be measured in plasma collected prior to and 24 hours after ingestion of each egg dose

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American Egg Board

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2013
Registry last updated
Jul 24, 2013

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.