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

NCT ID: NCT02445638

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-09-06

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Whole egg

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

Group Type: ACTIVE_COMPARATOR

Whole egg

Intervention Type: OTHER

Subjects will be provided with the equivalent of 2 whole eggs daily.

Yolk-free egg

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

Group Type: PLACEBO_COMPARATOR

Yolk-free egg

Intervention Type: OTHER

Subjects will be provided with the equivalent of 2 yolk-free eggs daily.

Interventions

Whole egg

Subjects will be provided with the equivalent of 2 whole eggs daily.

Intervention Type: OTHER

Yolk-free egg

Subjects will be provided with the equivalent of 2 yolk-free eggs daily.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francene Steinberg, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis

Davis, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31172172 (View on PubMed)

Other Identifiers

693261

Identifier Type: -

Identifier Source: org_study_id