NCT01672567

Brief Summary

The purpose of this study is to determine the effects of daily consumption of eggs or egg substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in participants with clinically established coronary heart disease (CHD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

August 9, 2011

Last Update Submit

March 25, 2020

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseEgg ConsumptionEndothelial Function

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function Flow mediated dilatation (FMD) as the percent change in brachial artery diameter from pre-cuff inflation to 60 seconds post-cuff release.

    FMD will be measured as the percent change in brachial artery diameter from pre-cuff inflation to 60-seconds post-cuff release (upper arm cuff position). In addition to brachial diameter at 60 seconds post-cuff release, flow after cuff deflation within the first 15 seconds will be used as an indicator of stimulus strength, hyperemic flow being the stimulus for endothelial reactivity.

    6 weeks

Secondary Outcomes (2)

  • Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio

    6 weeks

  • 3-Day Food Diary

    6 weeks

Study Arms (3)

Egg supplementation

EXPERIMENTAL

Daily consumption of 2 eggs for breakfast for 6 weeks

Dietary Supplement: Egg supplementation

Egg substitute

EXPERIMENTAL

Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks

Dietary Supplement: Egg substitute

Control diet

EXPERIMENTAL

Daily consumption of high carbohydrate breakfast diet for 6 weeks, consisting of any of the following choices during each day of the treatment period: bagel, waffles, pancakes, or cereal and milk

Dietary Supplement: Control diet

Interventions

Egg supplementationDIETARY_SUPPLEMENT

Daily consumption of 2 eggs for breakfast for 6 weeks

Egg supplementation
Egg substituteDIETARY_SUPPLEMENT

Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks

Egg substitute
Control dietDIETARY_SUPPLEMENT

Daily consumption of high carbohydrate breakfast diet for 6 weeks, consisting of any of the following choices during each day of the treatment period: bagel, waffles, pancakes, or cereal and milk

Control diet

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males age greater than 35 years;
  • Post-menopausal females not currently on hormone replacement therapy;
  • Non-smokers;
  • CVD as defined by the presence of at least one coronary stenosis \>50% determined angiographically or a documented history of myocardial infarction.

You may not qualify if:

  • Anticipated inability to complete study protocol for any reason;
  • Current eating disorder;
  • Use of lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning;
  • Regular use of high doses of vitamin E or C;
  • Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;
  • Regular use of fiber supplements;
  • Diabetes;
  • Sleep apnea;
  • Restricted diets by choice (i.e., vegetarian, vegan);
  • Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

Related Publications (1)

  • Katz DL, Gnanaraj J, Treu JA, Ma Y, Kavak Y, Njike VY. Effects of egg ingestion on endothelial function in adults with coronary artery disease: a randomized, controlled, crossover trial. Am Heart J. 2015 Jan;169(1):162-9. doi: 10.1016/j.ahj.2014.10.001. Epub 2014 Oct 7.

    PMID: 25497262DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • David L. Katz, MD, MPH

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 27, 2012

Study Start

October 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)