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HDL Lipidomic, Proteomic and Functional Changes in Women After Eating Eggs

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole egg
Yolk-free egg
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • 45-70 years old
  • Overweight or obese (BMI 25-35 kg/m2)
  • Post-menopausal (confirmed by clinical hormone levels assessed at screening if within one year of last menses)
  • Plasma HDL cholesterol greater than or equal to 50 mg/dL.

Exclusion Criteria:

  • Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer (active), or previous cardiovascular events
  • Having 3 or more traits of Metabolic Syndrome
  • Egg allergy or multiple food allergies or food intolerances that would significantly limit food intake
  • Smoker
  • Current consumption more than 1 alcoholic drink/ day
  • Extreme dietary or exercise patterns
  • Recent weight fluctuations (greater than 10% in the last six months)
  • Anemia
  • Taking prescription lipid medications or other supplements known to alter lipoprotein metabolism such as isoflavones, red yeast rice, or > 1 g of fish oil/day.
  • Taking exogenous hormones (i.e. hormone replacement therapy)

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Whole egg

Yolk-free egg

Arm Description

Subjects will be provided with a daily breakfast meal containing the equivalent of 2 whole eggs for 4 weeks.

Subjects will be provided with a daily breakfast meal containing the equivalent of 2 yolk-free eggs for 4 weeks.

Outcomes

Primary Outcome Measures

Change from baseline Apo A-1 concentration
The concentration of HDL Apo A-1 will be measured at baseline and after 4 weeks of whole egg, and after 4 weeks of yolk-free egg consumption, in randomized order.

Secondary Outcome Measures

Change from baseline HDL function
Parameters of HDL functionality (i.e. cholesterol efflux and anti-oxidant function) will be measured at baseline and after 4 weeks of whole egg, and after 4 weeks of yolk-free egg consumption, in randomized order.
Change from baseline HDL composition
The lipidomic and proteomic profiles of HDL will be measured at baseline and after 4 weeks of whole egg and after 4 weeks of yolk-free egg consumption, in randomized order.

Full Information

First Posted
May 11, 2015
Last Updated
January 22, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02445638
Brief Title
HDL Lipidomic, Proteomic and Functional Changes in Women After Eating Eggs
Official Title
HDL Lipidomic, Proteomic and Functional Changes in Response to Whole Egg Consumption in Overweight and Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
September 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this randomized, single blinded cross-over study is to investigate effects of daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL) composition and function in a population of overweight and obese postmenopausal women.
Detailed Description
The investigators hypothesize that after 4 weeks of daily consumption of whole egg versus yolk-free egg will result in differences in the HDL composition and profile of lipids and proteins (lipidome and proteome), which will be associated with changes in HDL functionality. It is further hypothesized that it will be possible to discriminate between responders and non-responders to eggs in terms of increasing both apolipoprotein A-1 (ApoA-I) content in the plasma, corresponding with more protective HDL particles; and increasing HDL functionality (cholesterol efflux and anti-oxidant capacity). Subjects will consume an egg free diet during study protocols, except for the egg meal provided by the study. The study is comprised of two 4-week feeding periods with a 4-week washout between testing periods. While on the study, subjects will consume the equivalent of two eggs for breakfast, either whole egg or yolk-free egg. Following a 2-week low-egg lead-in period, subjects will be randomly selected to start on either arm and cross over to the other arm after the 4-week washout period. Measured results will be compared between the baseline and the 4-week end point for each arm. Additional comparisons may be made between 4-week endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole egg
Arm Type
Active Comparator
Arm Description
Subjects will be provided with a daily breakfast meal containing the equivalent of 2 whole eggs for 4 weeks.
Arm Title
Yolk-free egg
Arm Type
Placebo Comparator
Arm Description
Subjects will be provided with a daily breakfast meal containing the equivalent of 2 yolk-free eggs for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Whole egg
Intervention Description
Subjects will be provided with the equivalent of 2 whole eggs daily.
Intervention Type
Other
Intervention Name(s)
Yolk-free egg
Intervention Description
Subjects will be provided with the equivalent of 2 yolk-free eggs daily.
Primary Outcome Measure Information:
Title
Change from baseline Apo A-1 concentration
Description
The concentration of HDL Apo A-1 will be measured at baseline and after 4 weeks of whole egg, and after 4 weeks of yolk-free egg consumption, in randomized order.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline HDL function
Description
Parameters of HDL functionality (i.e. cholesterol efflux and anti-oxidant function) will be measured at baseline and after 4 weeks of whole egg, and after 4 weeks of yolk-free egg consumption, in randomized order.
Time Frame
4 weeks
Title
Change from baseline HDL composition
Description
The lipidomic and proteomic profiles of HDL will be measured at baseline and after 4 weeks of whole egg and after 4 weeks of yolk-free egg consumption, in randomized order.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 45-70 years old Overweight or obese (BMI 25-35 kg/m2) Post-menopausal (confirmed by clinical hormone levels assessed at screening if within one year of last menses) Plasma HDL cholesterol greater than or equal to 50 mg/dL. Exclusion Criteria: Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer (active), or previous cardiovascular events Having 3 or more traits of Metabolic Syndrome Egg allergy or multiple food allergies or food intolerances that would significantly limit food intake Smoker Current consumption more than 1 alcoholic drink/ day Extreme dietary or exercise patterns Recent weight fluctuations (greater than 10% in the last six months) Anemia Taking prescription lipid medications or other supplements known to alter lipoprotein metabolism such as isoflavones, red yeast rice, or > 1 g of fish oil/day. Taking exogenous hormones (i.e. hormone replacement therapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francene Steinberg, PhD, RD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31172172
Citation
Sawrey-Kubicek L, Zhu C, Bardagjy AS, Rhodes CH, Sacchi R, Randolph JM, Steinberg FM, Zivkovic AM. Whole egg consumption compared with yolk-free egg increases the cholesterol efflux capacity of high-density lipoproteins in overweight, postmenopausal women. Am J Clin Nutr. 2019 Sep 1;110(3):617-627. doi: 10.1093/ajcn/nqz088.
Results Reference
derived

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HDL Lipidomic, Proteomic and Functional Changes in Women After Eating Eggs

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