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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Other: Whole egg
* Other: Yolk-free egg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |