- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577223
Egg Effects on the Immunomodulatory Properties of HDL
May 26, 2021 updated by: Catherine Andersen, Fairfield University
The purpose of this study is to investigate the effects of egg intake on markers of HDL function and immune inflammation in healthy adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Fairfield, Connecticut, United States, 06824
- Fairfield University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole Eggs
|
3 whole eggs per day for 4 weeks
|
Active Comparator: Egg White-Based Egg Substitute
|
3-egg equivalent of egg white-based egg substitute per day for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasted HDL-cholesterol
Time Frame: 16 weeks
|
Measurement of fasted plasma HDL-cholesterol levels (mg/dL) at the end of the run-in period, and two intervention arms.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasted HDL lipid composition
Time Frame: 16 weeks
|
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
|
Cholesterol-accepting capacity of serum
Time Frame: 16 weeks
|
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
|
Inflammatory potential of peripheral blood mononuclear cells
Time Frame: 16 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine J Andersen, PhD, RD, Fairfield University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2018
Primary Completion (Actual)
May 15, 2019
Study Completion (Actual)
May 15, 2019
Study Registration Dates
First Submitted
June 15, 2018
First Submitted That Met QC Criteria
July 2, 2018
First Posted (Actual)
July 5, 2018
Study Record Updates
Last Update Posted (Actual)
May 28, 2021
Last Update Submitted That Met QC Criteria
May 26, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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