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

NCT01906554 | Completed

• 1 other identifier: A12-1066-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Biomarkers of Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

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

  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

  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

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

Study Arms (1)

Egg Dose

EXPERIMENTAL

Other: Egg Dose

Interventions

Egg Dose OTHER

Different quantities of eggs

Egg Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Egg Board: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (1)

• Miller CA, Corbin KD, da Costa KA, Zhang S, Zhao X, Galanko JA, Blevins T, Bennett BJ, O'Connor A, Zeisel SH. Effect of egg ingestion on trimethylamine-N-oxide production in humans: a randomized, controlled, dose-response study. Am J Clin Nutr. 2014 Sep;100(3):778-86. doi: 10.3945/ajcn.114.087692. Epub 2014 Jun 18.

  PMID: 24944063 DERIVED

Study Officials

• Steven H Zeisel, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition and Pediatrics, Director, UNC Nutrition Research Institute

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 24, 2013
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-07

Locations

US (1)