Investigating Age-dependent Effects of Egg Intake on HDL and Immune Profiles
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedFirst Posted
Study publicly available on registry
October 17, 2023
CompletedStudy Start
First participant enrolled
January 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2025
CompletedMay 5, 2026
April 1, 2026
1.9 years
October 10, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in serum concentration of large HDL particles between diet periods
Measurement of serum large HDL particles (nmol/L) at the egg-free run-in period and the end of each intervention arm.
4 weeks
Study Arms (3)
Egg whites
ACTIVE COMPARATOR3 large egg equivalent of liquid egg whites per day for 4 weeks
Egg yolks
EXPERIMENTAL3 large egg equivalent of liquid egg yolks per day for 4 weeks
Whole eggs
EXPERIMENTAL3 large whole eggs per day for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- years old, or 50-75 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
You may not qualify if:
- \< 18 years old; 31-49 years old; \> 75 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, certain severe and/or relapsing/remitting autoimmune, inflammatory, or metabolic 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), or total cholesterol \< 120 mg/dL and HDL-cholesterol \< 15 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Connecticutlead
- American Egg Boardcollaborator
Study Sites (1)
University of Connecticut
Storrs, Connecticut, 06269, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine J Andersen, PhD, RDN
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 10, 2023
First Posted
October 17, 2023
Study Start
January 23, 2024
Primary Completion
December 29, 2025
Study Completion
December 29, 2025
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share