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

NCT05807334 | Unknown

• 1 other identifier: 2023-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Hyperlipidemia; Cardio-metabolic; Endothelial function

Outcome Measures

Primary Outcomes (2)

• Endothelial function, % flow-mediated dilatation

  Endothelial function measured as percent flow-mediated dilatation in the right brachial artery.

  Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs

• Serum LDL cholesterol, mg/dL

  Serum low-density lipoprotein (LDL) will be calculated using the formula LDL = Tchol - (TG/5 + HDL). See below for secondary outcome measures of total cholesterol (Tchol), high-density lipoprotein (HDL) and triglycerides (TG).

  Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs

Secondary Outcomes (20)

• High sensitivity C-reactive protein (CRP), mg/dL

  Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs

• Total cholesterol (Tchol), mg/dL

  Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs

• Triglycerides (TG), mg/dL

  Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs

• High-density lipoprotein (HDL), mg/dL

  Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs

• Total/HDL cholesterol ratio

  Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs

Study Arms (2)

DASH eating plan with eggs

EXPERIMENTAL

Participants will receive dietary guidance to follow the DASH eating plan with the addition of 2 whole eggs daily during this 8-week treatment period.

Other: DASH eating plan with eggs

DASH eating plan without eggs

ACTIVE COMPARATOR

Participants will receive dietary guidance to follow the DASH eating plan while excluding eggs from their eating plan during this 8-week treatment period.

Other: DASH eating plan without eggs

Interventions

DASH eating plan with eggs OTHER

Participants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to eat 2 whole eggs per day to supplement the DASH eating pattern.

DASH eating plan with eggs

DASH eating plan without eggs OTHER

Participants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to exclude eggs from their diet on a daily basis.

DASH eating plan without eggs

Eligibility Criteria

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

You may qualify if:

• Men \>18 years of age
• Post-menopausal women not currently on hormone replacement therapy
• Non-smokers
• Overweight/obese (i.e., 25kg/m² ≤ BMI ≤ 40kg/m² and weight \<350pounds)
• 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

You may not qualify if:

• Anticipated inability to complete study protocol for any reason
• Allergy to eggs
• Current eating disorder
• Restricted diets by choice that do not permit ingestion of eggs (e.g., vegan)
• 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
• Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators)
• Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment)
• 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
• Diagnosed diabetes
• Diagnosed sleep apnea; unless treated and have been stable with their medications for at least 3 months
• Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis)
• Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin or other regular use of anticoagulation
• Substance abuse (chronic alcoholism, other chemical dependency)
• 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)
• Conditions requiring regular use of NSAID medications such as Advil, naproxen, ibuprofen (examples of condition include lupus and rheumatoid arthritis)

Sponsors & Collaborators

• Griffin Hospital: lead
• Egg Nutrition Center: collaborator

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

RECRUITING

Related Publications (1)

• Njike VY, Ayettey RG, Foster JS, Comerford BP, Multany S, Gill AS. Effect of Daily Incorporation of Eggs in a Heart-Healthy Diet for 8 Weeks Compared with Their Exclusion on Cardio-Metabolic Risk Factors in Adults with Hyperlipidemia: A Randomized, Controlled, Crossover Trial. J Am Nutr Assoc. 2025 Sep 16:1-13. doi: 10.1080/27697061.2025.2560431. Online ahead of print.

  PMID: 40957619 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Eggs

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Valentine Y. Njike, MD, MPH

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, crossover design, controlled trial

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 11, 2023
• Study Start: March 7, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)