Plasma and Urine TMAO Formation and Changes to Oxidized L... | NCT01906554

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

NCT01906554

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Jul 24, 2013Estimated

Enrollment

6Actual

Phase

Not Applicable

Conditions

Biomarkers of Cardiovascular Disease

Interventions

Egg Dose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 16, 2013

First Submission Date that Met QC Criteria

Jul 20, 2013

First Posted Date

Jul 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2013

Last Update Posted Date

Jul 24, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Steven Zeisel, Professor of Nutrition and Pediatrics, Director, UNC Nutrition Research Institute, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Name	Class
American Egg Board	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Egg Dose	Experimental		Other: Egg Dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Egg Dose	Other	Different quantities of eggs	Egg Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes to plasma oxidized LDL		Oxidized LDL will be measured in plasma collected prior to and 24 hours after ingestion of each egg dose

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven H Zeisel, MD, PhD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina at Chapel Hill Nutrition Research Institute		Kannapolis	North Carolina	28081	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24944063	Derived	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.