Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 cardiovascular-diseases
Started Apr 2024
Shorter than P25 for phase_3 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
April 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
July 20, 2025
July 1, 2025
2.2 years
November 2, 2023
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
LDL-cholesterol change
Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. Change in LDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
4 weeks
Secondary Outcomes (15)
Triglyceride change
4 weeks
Total cholesterol change
4 weeks
HDL-cholesterol change
4 weeks
LDL-cholesterol to HDL-cholesterol ratio change
4 weeks
Change in particle size and number of LDL, HDL, VLDL and chylomicrons
4 weeks
- +10 more secondary outcomes
Other Outcomes (1)
Change in the composition of the gut microbiota
4 weeks
Study Arms (2)
Healthy Diet + Eggs (HD+E)
EXPERIMENTAL2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal
Healthy Diet (HD)
ACTIVE COMPARATOR2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penn State Universitylead
- American Egg Boardcollaborator
Study Sites (1)
The Pennylvania State University
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina Petersen
The Pennsylvania State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 7, 2023
Study Start
April 25, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After publication of all pre-specified primary and secondary outcomes
De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.