NCT06086795

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 23, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

October 10, 2023

Last Update Submit

April 29, 2026

Conditions

Keywords

DietLipoproteinsT-LymphocytesEggsAging

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 COMPARATOR

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

Other: Egg whites

Egg yolks

EXPERIMENTAL

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

Other: Egg yolks

Whole eggs

EXPERIMENTAL

3 large whole eggs per day for 4 weeks

Other: Whole eggs

Interventions

3 large whole eggs per day for 4 weeks

Whole eggs

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

Egg yolks

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

Egg whites

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Interventions

Egg YolkEgg White

Intervention Hierarchy (Ancestors)

EggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Catherine J Andersen, PhD, RDN

    University of Connecticut

    PRINCIPAL INVESTIGATOR

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

Locations