Egg Effects on the Immunomodulatory Properties of HDL

NCT ID: NCT03577223

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2019-05-15

Brief Summary

The purpose of this study is to investigate the effects of egg intake on markers of HDL function and immune inflammation in healthy adults.

Detailed Description

28 healthy men and women (age 18-35 years old) will be recruited to participate in a 16-week randomized crossover study. Upon enrollment, all subjects will enter a 4-week run-in egg-free period where they will refrain from consuming any egg-based foods (Period 1). Subjects will then enter the first intervention period, where they be randomly assigned to consume either 3 whole eggs/day or the equivalent amount of egg white-based egg substitute/day for 4 weeks (Period 2). Afterwards, subjects will enter a 4-week washout period where egg-based foods are restricted (Period 3), followed by a second intervention period, where they be assigned to the alternative whole egg- or egg white-based treatment for 4 weeks (Period 4). Subjects will come to the Department of Biology at Fairfield University every two weeks to check-in, and to pick up their egg products during the intervention periods. Subjects will be asked to maintain their normal diet and physical activity practices throughout all periods of the study. Subjects will complete 5-day dietary records and physical activity logs at the end of each study period.

Conditions

Lipid Metabolism; Inflammation

Study Design

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

Study Groups

Whole Eggs

Group Type: EXPERIMENTAL

Whole Eggs

Intervention Type: OTHER

3 whole eggs per day for 4 weeks

Egg White-Based Egg Substitute

Group Type: ACTIVE_COMPARATOR

Egg White-Based Egg Substitute

Intervention Type: OTHER

3-egg equivalent of egg white-based egg substitute per day for 4 weeks

Interventions

Whole Eggs

3 whole eggs per day for 4 weeks

Intervention Type: OTHER

Egg White-Based Egg Substitute

3-egg equivalent of egg white-based egg substitute per day for 4 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-35 years old
• Body mass index (BMI) < 30 kg/m2, or < 30% body fat for men and < 40% body fat for women
• Willingness to consume eggs or egg whites on a daily basis during study periods

Exclusion Criteria

• < 18 years old; > 35 years old
• BMI ≥ 30 kg/m2, or ≥ 30% body fat for men and ≥ 40% body fat for women
• Self-reported history of diabetes mellitus, coronary heart disease, stroke, renal problems, liver disease, cancer, pregnancy or lactation, autoimmunity, chronic infections, or egg allergy
• Taking lipid-lowering medications (e.g. statins, fibrates)
• A preexisting medical condition or implanted medical device that prevents participation in bioelectrical impedance measurements of body composition
• Clinical lipid and glucose values that are highly elevated, including fasting triglycerides levels higher than 500 mg/dL, fasting glucose higher than 126 mg/dL, and plasma total cholesterol greater than 240 mg/dL

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

Fairfield University

OTHER

Sponsor Role: lead

Responsible Party

Catherine Andersen

Associate Professor of Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine J Andersen, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Fairfield University

Locations

Fairfield University

Fairfield, Connecticut, United States

Countries

United States

Other Identifiers

0511

Identifier Type: -

Identifier Source: org_study_id