HDL Lipidomic, Proteomic and Functional Changes in Women After Eating Eggs
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 45 - 70 |
| Updated: | 1/26/2019 |
| Start Date: | May 2015 |
| End Date: | September 6, 2017 |
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.
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.
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.
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.
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)
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