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

HDL Lipidomic, Proteomic and Functional Changes in Response to Whole Egg Consumption in Overweight and Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: Whole egg; Other: Yolk-free egg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Whole egg; Subjects will be provided with a daily breakfast meal containing the equivalent of 2 whole eggs for 4 weeks.	Other: Whole egg; Subjects will be provided with the equivalent of 2 whole eggs daily.
Placebo Comparator: Yolk-free egg; Subjects will be provided with a daily breakfast meal containing the equivalent of 2 yolk-free eggs for 4 weeks.	Other: Yolk-free egg; Subjects will be provided with the equivalent of 2 yolk-free eggs daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Francene Steinberg, PhD, RD, University of California, Davis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): September 6, 2017
• Study Completion (Actual): September 6, 2017

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 693261