Eggs as Part of a Healthy Breakfast

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297464
• Other study ID #: H14-032
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: March 21, 2018
• Start date: July 2014
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2018
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spectrophotometry, NMR and ELISA will assess plasma lipids.		1 year
Secondary	Visual analog scales (VAS) and ELISA assays will assess satiety.		1 year