Eggs as Part of a Healthy Breakfast

Study Overview
=================
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.

Official Title
-----------------
Eggs as Part of a Healthy Breakfast: Lack of Association With Heart Disease Risk

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Eggs - 2 per day for breakfast
* Other: 1 packet of oatmeal per day


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eggs - 2 per day for breakfast<br>Participants will consume 2 eggs per day for breakfast for 4 weeks of the study. | Other: Eggs - 2 per day for breakfast<br>* 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.<br>Other: 1 packet of oatmeal per day<br>* 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.<br>|
| Experimental: Oatmeal - 1 packet per day for breakfast<br>Participants will consume 1 packet of oatmeal per day for breakfast for 4 weeks of the study. | Other: Eggs - 2 per day for breakfast<br>* 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.<br>Other: 1 packet of oatmeal per day<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectrophotometry, NMR and ELISA will assess plasma lipids. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scales (VAS) and ELISA assays will assess satiety. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk