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

University of California (UC) Davis

Status: Completed

Conditions: Overweight; Obesity

Treatments: Other: Yolk-free egg; Other: Whole egg

Study type: Interventional

Funder types: Other

Identifiers

NCT02445638

693261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Whole egg

Active Comparator group

Description:

Subjects will be provided with a daily breakfast meal containing the equivalent of 2 whole eggs for 4 weeks.

Treatment:

Other: Whole egg

Yolk-free egg

Placebo Comparator group

Description:

Subjects will be provided with a daily breakfast meal containing the equivalent of 2 yolk-free eggs for 4 weeks.

Treatment:

Other: Yolk-free egg