Clinical trial NCT02445638: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Change from baseline Apo A-1 concentration
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline HDL function
timeFrame: 4 weeks
measure: Change from baseline HDL composition
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Francene Steinberg, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
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.