Eggs as Part of a Healthy Breakfast

NCT ID: NCT02297464

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-03-31

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Eggs - 2 per day for breakfast

Participants will consume 2 eggs per day for breakfast for 4 weeks of the study.

Group Type: EXPERIMENTAL

Eggs - 2 per day for breakfast

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Oatmeal - 1 packet per day for breakfast

Participants will consume 1 packet of oatmeal per day for breakfast for 4 weeks of the study.

Group Type: EXPERIMENTAL

Eggs - 2 per day for breakfast

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Maria Luz Fernandez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Connecticut

Storrs, Connecticut, United States

Countries

United States

Other Identifiers

H14-032

Identifier Type: -

Identifier Source: org_study_id