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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445638
• Other study ID #: 693261
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: September 6, 2017

Study information

• Verified date: January 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 6, 2017
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Whole egg
Subjects will be provided with the equivalent of 2 whole eggs daily.
• Yolk-free egg
Subjects will be provided with the equivalent of 2 yolk-free eggs daily.

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Apo A-1 concentration	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.	4 weeks
Secondary	Change from baseline HDL function	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.	4 weeks
Secondary	Change from baseline HDL composition	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.	4 weeks