Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatments eggs - 2 per day for breakfast, 1 packet of oatmeal per day
Sponsor University of Connecticut
Start date July 2014
End date December 2014
Trial size 50 participants
Trial identifier NCT02297464, H14-032

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants will consume 2 eggs per day for breakfast for 4 weeks of the study.
eggs - 2 per day for breakfast
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.
1 packet of oatmeal per day
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.
(Experimental)
Participants will consume 1 packet of oatmeal per day for breakfast for 4 weeks of the study.
eggs - 2 per day for breakfast
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.
1 packet of oatmeal per day
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.

Primary Outcomes

Measure
Spectrophotometry, NMR and ELISA will assess plasma lipids.
time frame: 1 year

Secondary Outcomes

Measure
Visual analog scales (VAS) and ELISA assays will assess satiety.
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

Inclusion Criteria: - BMI 18.5-30, willing to consume eggs and oatmeal daily, proficient in English, and with a healthy lipid profile. Exclusion Criteria: - 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

Additional Information

Official title Eggs as Part of a Healthy Breakfast: Lack of Association With Heart Disease Risk
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Connecticut.