Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Connecticut
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
<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
Trial design
Design model
Crossover
Treatments tested in this trial
Egg whites
Other intervention3 large egg equivalent of liquid egg whites per day for 4 weeks
Whole eggs
Other intervention3 large whole eggs per day for 4 weeks
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Egg whitesActive comparator 1 intervention
Group B: Whole eggsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in serum concentration of large HDL particles between diet periods
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov