NCT07844616 · University of Connecticut
Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Egg whites
3 large egg equivalent of liquid egg whites per day for 4 weeks
OTHER
Whole eggs
3 large whole eggs per day for 4 weeks
Primary outcome measures
Change in serum concentration of large HDL particles between diet periods
Time frame: 4 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-50 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
- Do not fit any
Exclusion criteria
- \<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
Where
- Storrs, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 28, 2026 · Source of record for eligibility and locations