NCT07844616

Brief Summary

The purpose of this intervention study is to investigate the effects of daily egg intake on markers of gut health, high-density lipoprotein (HDL), metabolic, and immune cell profiles in adults with body mass indexes (BMI) in normal and obesity ranges. This study further aims to determine whether egg effects are associated with baseline gut microbiome profiles, and whether egg effects are different between males and females and by BMI status. The study will address the following objectives: Objective 1: Evaluate the effects of daily egg white vs. whole egg intake on gut health, microbiome, and metabolome profiles. Objective 2: Evaluate the effects of daily egg white vs. whole egg intake on HDL composition and function. Objective 3: Evaluate the effects of daily egg white vs. whole egg intake on immune profiles and function in culture (ex vivo). Participants will be asked to consume egg whites 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 be asked to complete surveys about dietary intake and physical activity, as well as provide blood and stool samples throughout the course of the study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress7%
Sep 2026Dec 2027

Study Start

First participant enrolled

September 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Obesity (BMI Equal to or >30)Immune FunctionHDLGut MicrobiomeHealthy Adult Participants

Keywords

EggsHDLObesityDiet interventionNutritionGut microbioomeImmune function

Outcome Measures

Primary Outcomes (1)

  • Change in serum concentration of large HDL particles between diet periods

    4 weeks

Study Arms (2)

Egg whites

ACTIVE COMPARATOR
Other: Egg whites

Whole eggs

EXPERIMENTAL
Other: Whole eggs

Interventions

Egg whitesOTHER

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

Egg whites
Whole eggsOTHER

3 large whole eggs per day for 4 weeks

Whole eggs

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old (at time of screening)
  • Premenopausal status for women
  • Body mass index (BMI) 18.5 to \< 25 kg/m2; or ³ 30 kg/m2 and \>30% and \>40% body fat for men and women, respectively
  • Willing to consume whole eggs and egg whites provided during the study on a daily basis, and refrain from other eggs or egg-based foods and beverages during the study

You may not qualify if:

  • \<18 years old and ≥ 51 years old
  • BMI \<18.5, 25-29.9, or body weight \< 110 pounds
  • Experienced \>10% weight change in the past 4 weeks
  • Elevated fasting glucose levels (fasting glucose higher than 126 mg/dL) and triglycerides greater than 500 mg/dL, or total cholesterol \< 120 mg/dL and HDL- cholesterol \< 15 mg/dL
  • Self-reported and/or physician-diagnosed history of severe constipation, diabetes mellitus, coronary heart disease, stroke, renal or liver disease, cancer, eating disorders, certain severe and/or relapsing/remitting autoimmune, inflammatory, intestinal or metabolic diseases, chronic infections, scleroderma, blood clotting disorders, intravenous drug use, or current pregnancy or lactation, postmenopausal
  • Allergy to eggs
  • Implanted medical device (e.g., pacemaker) or other health condition that would prevent measurement of body composition by bioelectrical impedence
  • Currently taking lipid-lowering medications (e.g., statins, fibrates), glucose-regulating medications, anti-inflammatory medications (e.g., NSAIDs, corticosteroids), or medications that primarily affect blood clotting (e.g., warfarin), long-term antibiotics or probiotics in the last 3 months or during the intervention
  • Active smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Egg White

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Catherine J Andersen, PhD, RDN

CONTACT

860-486-1704catherine.andersen@uconn.edu

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
Principal Investigator

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations

US(1)