NCT06120400 Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
| NCT ID | NCT06120400 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Penn State University |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 65 participants in total. It began in 2024-04-25 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine the effect of a healthy diet containing 2 eggs per day compared to a healthy diet containing 3 eggs per week on biomarkers of heart health after 4 weeks.
Eligibility 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
Contact & Investigator
Kristina Petersen
PRINCIPAL INVESTIGATOR
The Pennsylvania State University
Frequently Asked Questions
Who can join the NCT06120400 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 60 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06120400 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 65 participants.
Is NCT06120400 currently recruiting?
Yes, NCT06120400 is actively recruiting participants. Contact the research team at kup63@psu.edu for enrollment information.
Where is the NCT06120400 trial being conducted?
This trial is being conducted at University Park, United States.
Who is sponsoring the NCT06120400 clinical trial?
NCT06120400 is sponsored by Penn State University. The principal investigator is Kristina Petersen at The Pennsylvania State University. The trial plans to enroll 65 participants.