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Egg Effects on the Immunomodulatory Properties of HDL

F

Fairfield University

Status

Completed

Conditions

Lipid Metabolism
Inflammation

Treatments

Other: Whole Eggs
Other: Egg White-Based Egg Substitute

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Whole Eggs
Experimental group
Treatment:
Other: Whole Eggs
Egg White-Based Egg Substitute
Active Comparator group
Treatment:
Other: Egg White-Based Egg Substitute

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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