- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086795
Investigating Age-dependent Effects of Egg Intake on HDL and Immune Profiles
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-30 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
- Do not fit any exclusion criteria
Exclusion Criteria:
- < 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)
Study Plan
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 |
|---|---|
|
Active Comparator: Egg whites
3 large egg equivalent of liquid egg whites per day for 4 weeks
|
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
|
3 large egg equivalent of egg yolks per day for 4 weeks
|
|
Experimental: Whole eggs
3 large whole eggs per day for 4 weeks
|
3 large whole eggs per day for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in serum concentration of large HDL particles between diet periods
Time Frame: 4 weeks
|
Measurement of serum large HDL particles (nmol/L) at the egg-free run-in period and the end of each intervention arm.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine J Andersen, PhD, RDN, University of Connecticut
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-0174
- AG221113 (Other Grant/Funding Number: American Egg Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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