Egg Effects on the Immunomodulatory Properties of HDL

Sponsor
Fairfield University (Other)
Overall Status
Completed
CT.gov ID
NCT03577223
Collaborator
United States Department of Agriculture (USDA) (U.S. Fed)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Whole Eggs
  • Other: Egg White-Based Egg Substitute
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Egg Effects on the Immunomodulatory Properties of HDL
Actual Study Start Date :
Sep 7, 2018
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
May 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Whole Eggs

Other: Whole Eggs
3 whole eggs per day for 4 weeks

Active Comparator: Egg White-Based Egg Substitute

Other: Egg White-Based Egg Substitute
3-egg equivalent of egg white-based egg substitute per day for 4 weeks

Outcome Measures

Primary Outcome Measures

  1. Fasted HDL-cholesterol [16 weeks]

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

Secondary Outcome Measures

  1. Fasted HDL lipid composition [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.

  2. Cholesterol-accepting capacity of serum [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.

  3. Inflammatory potential of peripheral blood mononuclear cells [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fairfield University Fairfield Connecticut United States 06824

Sponsors and Collaborators

  • Fairfield University
  • United States Department of Agriculture (USDA)

Investigators

  • Principal Investigator: Catherine J Andersen, PhD, RD, Fairfield University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Catherine Andersen, Associate Professor of Biology, Fairfield University
ClinicalTrials.gov Identifier:
NCT03577223
Other Study ID Numbers:
  • 0511
First Posted:
Jul 5, 2018
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Catherine Andersen, Associate Professor of Biology, Fairfield University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2021