Egg Effects on the Immunomodulatory Properties of HDL | NCT03577223

Studies
Egg Effects on the Immunomodulatory Properties of HDL

NCT03577223

Sponsor

Fairfield University

Status

Completed

Last Update Posted

May 28, 2021Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Lipid Metabolism
Inflammation

Interventions

Whole Eggs
Egg White-Based Egg Substitute

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 7, 2018Actual

Primary Completion Date

May 15, 2019Actual

Completion Date

May 15, 2019Actual

First Submitted Date

Jun 15, 2018

First Submission Date that Met QC Criteria

Jul 2, 2018

First Posted Date

Jul 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2021

Last Update Posted Date

May 28, 2021Actual

Name	Class
United States Department of Agriculture (USDA)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

28 healthy men and women (age 18-35 years old) will be recruited to participate in a 16-week randomized crossover study. Upon enrollment, all subjects will enter a 4-week run-in egg-free period where they will refrain from consuming any egg-based foods (Period 1). Subjects will then enter the first intervention period, where they be randomly assigned to consume either 3 whole eggs/day or the equivalent amount of egg white-based egg substitute/day for 4 weeks (Period 2). Afterwards, subjects will enter a 4-week washout period where egg-based foods are restricted (Period 3), followed by a second intervention period, where they be assigned to the alternative whole egg- or egg white-based treatment for 4 weeks (Period 4). Subjects will come to the Department of Biology at Fairfield University every two weeks to check-in, and to pick up their egg products during the intervention periods. Subjects will be asked to maintain their normal diet and physical activity practices throughout all periods of the study. Subjects will complete 5-day dietary records and physical activity logs at the end of each study period.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Whole Eggs	Experimental		Other: Whole Eggs
Egg White-Based Egg Substitute	Active Comparator		Other: Egg White-Based Egg Substitute

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole Eggs	Other	3 whole eggs per day for 4 weeks	Whole Eggs
Egg White-Based Egg Substitute

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Fasted HDL lipid composition	HDL subfractions (d = 1.063-1.21) will be isolated from plasma by ultracentrifugation collected at the end of the run-in period and two intervention arms. HDL fractions will be analyzed for glycerphospholipid (phosphatidylcholine, phosphatidylethanolamine, lysophosphatidylcholine, phosphatidylinositol) and sphingolipid (sphingomyelin) composition by mass spectrometry. Each lipid class will be presented as a percent (%) of total HDL lipids.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-35 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

Exclusion Criteria:

< 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine J Andersen, PhD, RD	Fairfield University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fairfield University		Fairfield	Connecticut	06824	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided