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Clinical Trials/NCT06086795
NCT06086795Active, not recruitingNot Applicable

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

University of Connecticut2 sites in 1 country46 target enrollmentStarted: January 23, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
46
Locations
2
Primary Endpoint
Change in serum concentration of large HDL particles between diet periods

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Catherine Andersen

Associate Professor

University of Connecticut

Study Sites (2)

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