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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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. Participants will be randomized to receive 1 of 2 treatment sequence permutations (i.e., DASH eating plan with eggs and DASH eating plan without eggs), with an 8-week washout period between treatment assignments. After randomization, participants will undergo a 4-week run-in period of a DASH eating plan without egg products before initiating the first of 2 treatment phases in their randomly-assigned sequence permutation.

Specific Aims

1. To assess the effects of the inclusion of 2 whole eggs/day for 8 weeks in a DASH eating plan, as compared with their exclusion, on endothelial function measured as flow-mediated dilatation and on LDL cholesterol in hyperlipidemic adults.
2. To determine the effects of the inclusion of 2 whole eggs/day in the context of a DASH eating plan, as compared with their exclusion, on cardio-metabolic risk factors and diet quality in adults with hyperlipidemia over a period of 8 weeks.

Conditions

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, crossover design, controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DASH eating plan with eggs

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

DASH eating plan without eggs

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes