Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults

Description

This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers and diet quality in hyperlipidemic adults.

Conditions

Hyperlipidemias

Study Overview

Study Details

Study overview

This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers and diet quality in hyperlipidemic adults.

Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Cardio-Metabolic Risk Factors and Diet Quality in Hyperlipidemic Adults

Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults

Condition
Hyperlipidemias
Intervention / Treatment

-

Contacts and Locations

Derby

Yale-Griffin Prevention Research Center, Derby, Connecticut, United States, 06418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Men \>18 years of age
  • 2. Post-menopausal women not currently on hormone replacement therapy
  • 3. Non-smokers
  • 4. Overweight/obese (i.e., 25kg/m² ≤ BMI ≤ 40kg/m² and weight \<350pounds)
  • 5. Total cholesterol of 240-300 mg/dl and /or LDL cholesterol of 130-190 mg/dl, and/or a total cholesterol to HDL ratio of \>5.7
  • 1. Failure to meet inclusion criteria
  • 2. Anticipated inability to complete study protocol for any reason
  • 3. Allergy to eggs
  • 4. Current eating disorder
  • 5. Restricted diets by choice that do not permit ingestion of eggs (e.g., vegan)
  • 6. Unstable use of lipid-lowering or antihypertensive medications (i.e., change in dose during the three months prior to enrollment) and/or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning
  • 7. Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators)
  • 8. Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment)
  • 9. Regular use of high doses of vitamin E (\>400IU/day) or vitamin C (\>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and/or fiber supplements, unless willing to discontinue supplementation for the study duration
  • 10. Diagnosed diabetes
  • 11. Diagnosed sleep apnea; unless treated and have been stable with their medications for at least 3 months
  • 12. Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis)
  • 13. Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin or other regular use of anticoagulation
  • 14. Substance abuse (chronic alcoholism, other chemical dependency)
  • 15. Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
  • 16. Conditions requiring regular use of NSAID medications such as Advil, naproxen, ibuprofen (examples of condition include lupus and rheumatoid arthritis)
  • 17. For women: Use of hormone replacement therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Griffin Hospital,

Valentine Y. Njike, MD, MPH, PRINCIPAL_INVESTIGATOR, Griffin Hospital

Study Record Dates

2024-07