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Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how eating egg whites or whole eggs each day affects gut health, HDL (“good” cholesterol), and the body’s defenses against illness. It is for adults ages 18–50 with a BMI in the normal or obesity range. Participants eat each type of egg for 4 weeks, avoid eggs for 8 weeks at other times, fill out surveys, and give blood and stool samples.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–50 years old at screening.
  • Women must not have reached menopause, when monthly periods end.
  • Your BMI, a measure of weight compared with height, must be 18.5 to less than 25; or it must be 30 or higher with body fat above 30% for men or above 40% for women.
  • You must be willing to eat the study’s whole eggs and egg whites daily when asked, and avoid other eggs and foods or drinks made with eggs.
  • You must not meet any of the rules that would keep you out of the study.

Who can't join

  • You are under 18 or 51 or older; have a BMI below 18.5 or from 25–29.9; weigh under 110 pounds; or had a weight change greater than 10% in the past 4 weeks.
  • Your blood tests show fasting blood sugar above 126 mg/dL and triglycerides (a blood fat) above 500 mg/dL; or total cholesterol below 120 mg/dL and HDL cholesterol below 15 mg/dL.
  • You have a history of severe constipation, diabetes, heart artery disease, stroke, kidney or liver disease, cancer, an eating disorder, long-lasting infections, blood clotting problems, or injecting drugs into a vein. Certain serious or recurring immune, swelling-related, gut, or food-processing diseases also rule you out, including scleroderma, which can harden skin and other tissues.
  • You are pregnant, breastfeeding, or have reached menopause.
  • You are allergic to eggs.
  • You have an implanted medical device, such as a pacemaker, or another condition that prevents a body fat test using a small electrical current.
  • You currently take medicines that lower blood fats, control blood sugar, reduce inflammation, or mainly affect blood clotting. Long-term antibiotics or probiotics (helpful bacteria supplements) in the past 3 months or during the study also rule you out.
  • You currently smoke.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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

Study sites (1)

CT