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Completed

NCT Number: NCT02445638

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

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.

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Key information

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Whole egg

Other

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

Yolk-free egg

Other

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

Primary outcomes

  1. Change from baseline Apo A-1 concentration

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Change from baseline HDL function

    Time frame: 4 weeks

    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.

  2. Change from baseline HDL composition

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 15, 2015
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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