Eggs as Part of a Healthy Breakfast
1 other identifier
interventional
50
1 country
1
Brief Summary
Contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (CHD), chronic inflammation, and insulin resistance. The following study is designed to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that the consumption of 2 eggs per day will not negatively impact plasma lipids in a young, healthy population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Jul 2014
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 22, 2018
March 1, 2018
5 months
November 13, 2014
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spectrophotometry, NMR and ELISA will assess plasma lipids.
1 year
Secondary Outcomes (1)
Visual analog scales (VAS) and ELISA assays will assess satiety.
1 year
Study Arms (2)
Eggs - 2 per day for breakfast
EXPERIMENTALParticipants will consume 2 eggs per day for breakfast for 4 weeks of the study.
Oatmeal - 1 packet per day for breakfast
EXPERIMENTALParticipants will consume 1 packet of oatmeal per day for breakfast for 4 weeks of the study.
Interventions
11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.
11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.
Eligibility Criteria
You may qualify if:
- BMI 18.5-30, willing to consume eggs and oatmeal daily, proficient in English, and with a healthy lipid profile.
You may not qualify if:
- Currently have liver disease, renal disease, diabetes, cancer, history of stroke or heart disease
- Currently taking glucose lowering drugs or supplements
- Plasma triglycerides \>500 mg/dL, glucose \>126, total cholesterol \>240
- Pregnant, lactating, or have endocrine or metabolic disorders
- BMI ≥ 30
- Blood pressure \> 140/90 (average of 3 readings)
- Allergies to eggs
- Celiac disease or gluten sensitivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Connecticut
Storrs, Connecticut, 06269, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 13, 2014
First Posted
November 21, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2014
Study Completion
March 1, 2018
Last Updated
March 22, 2018
Record last verified: 2018-03