Clinical trial NCT03577223: Egg Effects on the Immunomodulatory Properties of HDL
Official title: Egg Effects on the Immunomodulatory Properties of HDL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism
Inflammation
Keywords: Egg
HDL
Inflammation
Lead sponsor: Fairfield University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2018-07-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Fasted HDL-cholesterol
timeFrame: 16 weeks
Secondary outcomes:
measure: Fasted HDL lipid composition
timeFrame: 16 weeks
measure: Cholesterol-accepting capacity of serum
timeFrame: 16 weeks
measure: Inflammatory potential of peripheral blood mononuclear cells
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Fairfield University
state: Connecticut
Study officials:
affiliation: Fairfield University
name: Catherine J Andersen, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: