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Egg Effects on the Immunomodulatory Properties of HDL

Egg Effects on the Immunomodulatory Properties of HDL

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03577223
Enrollment
28
Registered
2018-07-05
Start date
2018-09-07
Completion date
2019-05-15
Last updated
2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipid Metabolism, Inflammation

Keywords

Egg, HDL, Inflammation

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.

Interventions

3 whole eggs per day for 4 weeks

OTHEREgg White-Based Egg Substitute

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

Sponsors

United States Department of Agriculture (USDA)
CollaboratorFED
Fairfield University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fasted HDL-cholesterol16 weeksMeasurement of fasted plasma HDL-cholesterol levels (mg/dL) at the end of the run-in period, and two intervention arms.

Secondary

MeasureTime frameDescription
Inflammatory potential of peripheral blood mononuclear cells16 weeksPeripheral blood mononuclear cells (PBMCs) will be isolated at the end of the egg-free run-in period and both intervention periods. PBMCs will be cultured ex vivo and stimulated with lipopolysaccharide. Media will be collected to measure tumor necrosis factor alpha concentrations (pg/mL) in cell media.
Fasted HDL lipid composition16 weeksHDL subfractions (d = 1.063-1.21) will be isolated from plasma by ultracentrifugation collected at the end of the run-in period and two intervention arms. HDL fractions will be analyzed for glycerphospholipid (phosphatidylcholine, phosphatidylethanolamine, lysophosphatidylcholine, phosphatidylinositol) and sphingolipid (sphingomyelin) composition by mass spectrometry. Each lipid class will be presented as a percent (%) of total HDL lipids.
Cholesterol-accepting capacity of serum16 weeksThe cholesterol efflux from macrophages to subject serum will be measured at the end of the egg-free run-in period and both intervention periods using a fluorescent cholesterol efflux kit. Results will be expressed as % cholesterol efflux, calculated as (fluorescence intensity of media/\[fluorescent intensity of cell lysates + media\]) x 100.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026