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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Other: Yolk-free egg; Other: Whole egg

• Registration Number: NCT02445638
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Primary Completion: 2017-09-06
• Study Completion: 2017-09-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Yolk-free egg	Yolk-free egg	Subjects will be provided with a daily breakfast meal containing the equivalent of 2 yolk-free eggs for 4 weeks.
Whole egg	Whole egg	Subjects will be provided with a daily breakfast meal containing the equivalent of 2 whole eggs for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline Apo A-1 concentration	4 weeks	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

Name	Time	Method
Change from baseline HDL function	4 weeks	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	4 weeks	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.

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Davis, California, United States