Egg Effects on the Immunomodulatory Properties of HDL

Inflammation Clinical Trial

Official title:

Egg Effects on the Immunomodulatory Properties of HDL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577223
• Other study ID #: 0511
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2021
• Source: Fairfield University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Lipid Metabolism

Intervention

Other:
• Whole Eggs
3 whole eggs per day for 4 weeks
• Egg White-Based Egg Substitute
3-egg equivalent of egg white-based egg substitute per day for 4 weeks

Locations

Country	Name	City	State
United States	Fairfield University	Fairfield	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Fairfield University	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasted HDL-cholesterol	Measurement of fasted plasma HDL-cholesterol levels (mg/dL) at the end of the run-in period, and two intervention arms.	16 weeks
Secondary	Fasted HDL lipid composition	HDL 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.	16 weeks
Secondary	Cholesterol-accepting capacity of serum	The 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.	16 weeks
Secondary	Inflammatory potential of peripheral blood mononuclear cells	Peripheral 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.	16 weeks