Obesity (BMI Equal to or >30)NCT07844616
Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles
A study testing Egg whites and Whole eggs in people with Obesity (BMI Equal to or >30) and Immune Function, run by University of Connecticut at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (BMI Equal to or >30), Immune Function, HDL
- What is being tested?
- Egg whites and Whole eggs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- <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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Connecticut
Storrs, Connecticut, 06269
Catherine J. Andersen, PhD, RDN, 860-486-1704, catherine.andersen@uconn.edu
About this study
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.
Read more
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.
- Conditions
- Obesity (BMI Equal to or >30), Immune Function, HDL, Gut Microbiome, Healthy Adult Participants
- Being tested
- Egg whites, Whole eggs
- Keywords
- Eggs, HDL, Obesity, Diet intervention, Nutrition, Gut microbioome, Immune function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg whitesOther
3 large egg equivalent of liquid egg whites per day for 4 weeks
Whole eggsOther
3 large whole eggs per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Egg whites | Active comparator | Not described Receives: Other: Egg whites |
| Whole eggs | Experimental | Not described Receives: Other: Whole eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum concentration of large HDL particles between diet periods
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start5 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI Equal to or >30)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Andersen, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844616
- Sponsor's protocol ID
- B2025-0404/25-08-494-910
- Other IDs
- 2025-67017-45105, 2025
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided