Investigating Age-dependent Effects of Egg Intake on HDL and Immune Profiles

Sponsor
University of Connecticut (Other)
Overall Status
Recruiting
CT.gov ID
NCT06086795
Collaborator
American Egg Board (Other)
40
1
3
32
1.3

Study Details

Study Description

Brief Summary

The goal of this intervention study is to determine whether consumption of different fractions of chicken eggs, including egg whites, egg yolks, and whole eggs, confer different changes in markers of HDL function and T cell profiles in younger vs. older men and women.

The study will address the following objectives:
  • Objective 1: Determine if daily consumption of egg fractions differentially alter HDL profiles across age groups.

  • Objective 2: Determine if daily consumption of egg fractions differentially alter immune cell profiles across age groups.

Participants will be asked to consume egg whites, egg yolks, and whole eggs on a daily basis for 4-weeks each, and avoid eating eggs for a total of 8 weeks at different points in the study. Participants will additionally be provided guidance on following a generally healthy diet, and will be asked to complete surveys about dietary intake and physical activity, as well as provide blood samples throughout the course of the study.

Researchers will compare whether daily consumption of egg whites, egg yolks, and whole eggs differentially alter markers of HDL function and T cell profiles in younger vs. older adults.

Condition or Disease Intervention/Treatment Phase
  • Other: Whole eggs
  • Other: Egg yolks
  • Other: Egg whites
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Investigating Age-dependent Effects of Egg Intake on HDL and Immune Profiles
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Egg whites

3 large egg equivalent of liquid egg whites per day for 4 weeks

Other: Egg whites
3 large egg equivalent of egg whites per day for 4 weeks

Experimental: Egg yolks

3 large egg equivalent of liquid egg yolks per day for 4 weeks

Other: Egg yolks
3 large egg equivalent of egg yolks per day for 4 weeks

Experimental: Whole eggs

3 large whole eggs per day for 4 weeks

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

Outcome Measures

Primary Outcome Measures

  1. Change in serum concentration of large HDL particles between diet periods [4 weeks]

    Measurement of serum large HDL particles (nmol/L) at the egg-free run-in period and the end of each intervention arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18-30 years old, or 60-70 years old (at time of screening)

  • Body mass index (BMI) < 30 kg/m2

  • Willing to consume whole eggs, egg whites, or egg yolks on a daily basis during study periods, and refrain from eating eggs during other study periods

  • Do not fit any exclusion criteria

Exclusion Criteria:
  • <18 years old; 31-59 years old; >70 years old

  • BMI ≥ 30 kg/m2 or body weight < 110 pounds

  • Weight changes > 10% over the last 4 weeks

  • Self-reported history of diabetes, heart disease, stroke, renal or liver disease, cancer, eating disorders, autoimmune diseases, chronic inflammatory diseases, chronic infections, scleroderma, blood clotting disorders, intravenous drug use, or current pregnancy or lactation

  • Allergy or intolerance to eggs, egg components, or egg products

  • Implanted medical device (e.g., pacemaker) or other health condition that would prevent measurement of body composition by bioelectrical impedance

  • Highly elevated fasting lipid and glucose levels (triglyceride levels higher than 500 mg/dL, fasting glucose higher than 126 mg/dL)

  • Currently taking lipid-lowering medications (e.g. statins, fibrates), anti-inflammatory medications (e.g., NSAIDs, corticosteroids), or medications that primarily affect blood clotting (e.g., warfarin)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Connecticut Storrs Connecticut United States 06269

Sponsors and Collaborators

  • University of Connecticut
  • American Egg Board

Investigators

  • Principal Investigator: Catherine J Andersen, PhD, RDN, University of Connecticut

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Catherine Andersen, Associate Professor, University of Connecticut
ClinicalTrials.gov Identifier:
NCT06086795
Other Study ID Numbers:
  • H22-0174
  • AG221113
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
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, University of Connecticut

Study Results

No Results Posted as of Oct 17, 2023