Recruiting

Eggs

Sponsor:

Griffin Hospital

Code:

NCT05807334

Conditions

Hyperlipidemias

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

DASH eating plan with eggs

DASH eating plan without eggs

Study Details

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

Study ID

NCT05807334

Start date

Mar 7, 2023

Status verified date

Mar, 2023

Completion date

Jul, 2024

Anticipated

Primary completion date

Apr, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: DASH eating plan with eggs

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.

active comparator: DASH eating plan without eggs

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

Interventions

DASH eating plan with eggs

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 without eggs

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.

Primary outcome measure

  • Endothelial function, % flow-mediated dilatation [ Time Frame: 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 [ Time Frame: Change from baseline at the end of each 8-week treatment period: DASH eating plan with eggs; DASH eating plan without eggs ]

Central Contacts and Locations

Central contacts

Locations

Yale-Griffin Prevention Research Center

Recruiting

Derby, Connecticut, United States, 06418

Contacts

Principal Investigator:

Valentine Y. Njike, MD,MPH

More Information

Sponsor

Griffin Hospital

Last update posted

Apr 11, 2023

Last verified

Mar, 2023

Keywords

  • Hyperlipidemia
  • Cardio-metabolic
  • Endothelial function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Griffin Hospital on 2023-04-11.