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

NCT02445638 | Completed

• 1 other identifier: 693261
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline HDL function

  4 weeks

• Change from baseline HDL composition

  4 weeks

Study Arms (2)

Whole egg

ACTIVE COMPARATOR

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

Other: Whole egg

Yolk-free egg

PLACEBO COMPARATOR

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

Other: Yolk-free egg

Interventions

Whole egg OTHER

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

Whole egg

Yolk-free egg OTHER

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

Yolk-free egg

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Related Publications (1)

• 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.

  PMID: 31172172 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francene Steinberg, PhD, RD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2015
• Primary Completion: September 6, 2017
• Study Completion: September 6, 2017
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (1)