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Eggs in Heart-Healthy Diet for High Cholesterol

N/A
Recruiting
Led By Valentine Y. Njike, MD, MPH
Research Sponsored by Griffin Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men >18 years of age
Overweight/obese (i.e., 25kg/m² ≤ BMI ≤ 40kg/m² and weight <350 pounds)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of each 8-week treatment period: dash eating plan with eggs; dash eating plan without eggs
Awards & highlights

Study Summary

This trial tests the effects of eating 2 whole eggs a day for 8 weeks on heart health and diet quality in people with high cholesterol.

Who is the study for?
Adults with high cholesterol who are non-smokers, men over 18, or post-menopausal women not on hormone therapy. Participants should be overweight but under 350 pounds and have specific cholesterol levels. Excluded are those with unstable medical conditions, substance abuse issues, certain medication use, diagnosed diabetes or heart disease, egg allergies, or restrictive diets like veganism.Check my eligibility
What is being tested?
The trial is testing the impact of including two whole eggs daily in a DASH diet versus excluding them for hyperlipidemic adults. Over eight weeks, it will compare how each approach affects heart health risk factors and overall diet quality using a cross-over design where participants switch between diets.See study design
What are the potential side effects?
Since this study involves dietary changes rather than medication or invasive procedures, side effects may include digestive discomfort due to dietary adjustments. Specific side effects related to egg consumption can vary individually.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man over 18 years old.
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My BMI is between 25 and 40, and I weigh less than 350 pounds.
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I am a post-menopausal woman not on hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of each 8-week treatment period: dash eating plan with eggs; dash eating plan without eggs
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of each 8-week treatment period: dash eating plan with eggs; dash eating plan without eggs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endothelial function, % flow-mediated dilatation
Serum LDL cholesterol, mg/dL
Secondary outcome measures
Body fat, %
Body mass index (BMI) (weight in kg/height in meters squared)
Body water, %
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DASH eating plan with eggsExperimental Treatment1 Intervention
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 II: DASH eating plan without eggsActive Control1 Intervention
Participants will receive dietary guidance to follow the DASH eating plan while excluding eggs from their eating plan during this 8-week treatment period.

Find a Location

Who is running the clinical trial?

Griffin HospitalLead Sponsor
24 Previous Clinical Trials
1,493 Total Patients Enrolled
Egg Nutrition CenterOTHER
13 Previous Clinical Trials
961 Total Patients Enrolled
Valentine Y. Njike, MD, MPHPrincipal InvestigatorGriffin Hospital
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

DASH eating plan with eggs (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05807334 — N/A
High Cholesterol Research Study Groups: DASH eating plan with eggs, DASH eating plan without eggs
High Cholesterol Clinical Trial 2023: DASH eating plan with eggs Highlights & Side Effects. Trial Name: NCT05807334 — N/A
DASH eating plan with eggs (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05807334 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this experiment?

"Affirmative, according to information posted on clinicaltrials.gov this trial is recruiting participants. It was initially made available on March 7th 2023 and subsequently updated the 28th of that same month. The study requires 45 individuals at a single medical centre."

Answered by AI

Are there opportunities for volunteers to partake in this experiment?

"Indeed, clinicaltrials.gov indicates that the research is actively recruiting for participants. The project was first made public on March 7th 2023 and has since been updated on March 28th 2023. 45 individuals will be accepted at a single site."

Answered by AI

What is the expected outcome from this trial?

"This study aims to analyze the effects of a DASH diet with or without eggs on serum LDL cholesterol levels over 8-week periods. Secondary objectives include assessing total cholesterol, triglycerides and high-density lipoprotein values obtained from certified phlebotomists in Griffin Hospital laboratory."

Answered by AI

Who else is applying?

What site did they apply to?
Yale-Griffin Prevention Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults
2023. "Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05807334.
~21 spots leftby May 2025
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