RECRUITING

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

Conditions

Hyperlipidemias Hyperlipidemia Cardio-metabolic Endothelial function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-07

Study Completion:2024-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05807334

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Rockiy G. Ayettey, MS, DHSc.

CONTACT

203-732-1125

rockiy.ayettey@yalegriffinprc.org

Beth P. Comerford, MS

CONTACT

203-732-1266

beth.comerford@yalegriffinprc.org

Principal Investigator

Valentine Y. Njike, MD, MPH

PRINCIPAL_INVESTIGATOR

Griffin Hospital

Study Locations (Sites)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418

United States

Collaborators and Investigators

Sponsor: Griffin Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-07

Study Completion Date2024-07

Study Record Updates

Study Start Date2023-03-07

Study Completion Date2024-07

Terms related to this study

Keywords Provided by Researchers

Hyperlipidemia
Cardio-metabolic
Endothelial function

Additional Relevant MeSH Terms

Hyperlipidemias