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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles
- ClinicalTrials.gov ID
- NCT07844616
- Acronym / sponsor ID
- B2025-0404/25-08-494-910
- Conditions
- Obesity (BMI Equal to or >30), Immune Function, HDL, Gut Microbiome, Healthy Adult Participants
- Keywords
- Eggs, HDL, Obesity, Diet intervention, Nutrition, Gut microbioome, Immune function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg whites | Active comparator | Other: Egg whites |
| Whole eggs | Experimental | Other: Whole eggs |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg whites3 large egg equivalent of liquid egg whites per day for 4 weeks | Other | Egg whites |
| Whole eggs3 large whole eggs per day for 4 weeks | Other | Whole eggs |
Primary outcome
Change in serum concentration of large HDL particles between diet periods
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine J Andersen, PhD, RDN (860-486-1704, catherine.andersen@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum concentration of large HDL particles between diet periods (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.