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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03577223
Other study ID # 0511
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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