Egg Effects on the Immunomodulatory Properties of HDL
1 other identifier
interventional
28
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of egg intake on markers of HDL function and immune inflammation in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedStudy Start
First participant enrolled
September 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedMay 28, 2021
May 1, 2021
8 months
June 15, 2018
May 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasted HDL-cholesterol
Measurement of fasted plasma HDL-cholesterol levels (mg/dL) at the end of the run-in period, and two intervention arms.
16 weeks
Secondary Outcomes (3)
Fasted HDL lipid composition
16 weeks
Cholesterol-accepting capacity of serum
16 weeks
Inflammatory potential of peripheral blood mononuclear cells
16 weeks
Study Arms (2)
Whole Eggs
EXPERIMENTALEgg White-Based Egg Substitute
ACTIVE COMPARATORInterventions
3-egg equivalent of egg white-based egg substitute per day for 4 weeks
Eligibility Criteria
You may qualify if:
- years old
- Body mass index (BMI) \< 30 kg/m2, or \< 30% body fat for men and \< 40% body fat for women
- Willingness to consume eggs or egg whites on a daily basis during study periods
You may not qualify if:
- \< 18 years old; \> 35 years old
- BMI ≥ 30 kg/m2, or ≥ 30% body fat for men and ≥ 40% body fat for women
- Self-reported history of diabetes mellitus, coronary heart disease, stroke, renal problems, liver disease, cancer, pregnancy or lactation, autoimmunity, chronic infections, or egg allergy
- Taking lipid-lowering medications (e.g. statins, fibrates)
- A preexisting medical condition or implanted medical device that prevents participation in bioelectrical impedance measurements of body composition
- Clinical lipid and glucose values that are highly elevated, including fasting triglycerides levels higher than 500 mg/dL, fasting glucose higher than 126 mg/dL, and plasma total cholesterol greater than 240 mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fairfield University
Fairfield, Connecticut, 06824, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine J Andersen, PhD, RD
Fairfield University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Biology
Study Record Dates
First Submitted
June 15, 2018
First Posted
July 5, 2018
Study Start
September 7, 2018
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
May 28, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share