Effects of a healthy diet with eggs on heart health
Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study
This study tests if eating two eggs a day as part of a healthy diet can improve heart health compared to eating three eggs a week for people with certain heart risk factors.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT06120400 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the impact of a healthy dietary pattern that includes two eggs per day compared to a diet with three eggs per week on cardiovascular health biomarkers over a four-week period. It employs a randomized, crossover design to ensure that participants experience both dietary patterns. The study adheres to the 2020-2025 Dietary Guidelines for Americans and focuses on individuals with specific cardiovascular risk factors. Participants will be monitored for changes in heart health indicators throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates are adults with elevated LDL cholesterol levels, a BMI between 25-35, and who consume fewer than 14 eggs per week.
Not a fit: Patients with diabetes, significant cardiovascular history, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how egg consumption within a healthy diet may positively influence heart health.
How similar studies have performed: Similar studies have shown promising results regarding dietary patterns and cardiovascular health, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * LDL-C ≥115 mg/dL and ≤190 mg/L * BMI of 25-35 kg/m2 * Intake of \<14 eggs/week for the prior 3 months * Blood pressure \<140/90 mmHg * Fasting blood glucose \<126 mg/dL * Fasting triglycerides \<350 mg/dL * ≤10% change in body weight in the prior 6 months Exclusion Criteria: * Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL * Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs * Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period * Diagnosed liver, kidney, or autoimmune disease * Prior cardiovascular event (e.g., stroke, heart attack) * Current pregnancy or intention of pregnancy within the next 6 months * Lactation within prior 6 months * Follows a vegetarian or vegan diet * Food allergies/intolerance/sensitives/dislikes of foods included in the study menu * Antibiotic use within the prior 1 month * Oral steroid use within the prior 1 month * Use of tobacco or nicotine containing products with in the past 6 months * Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence) * Participation in another clinical trial within 30 days of baseline * Currently following a restricted or weight loss diet * Prior bariatric surgery * Intake of \>14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits
Where this trial is running
University Park, Pennsylvania
- The Pennylvania State University — University Park, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kristina Petersen — The Pennsylvania State University
- Study coordinator: Kristina Petersen, PhD
- Email: kup63@psu.edu
- Phone: 814-865-7206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.