Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
NCT ID: NCT06120400
Last Updated: 2025-07-20
Study Results
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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RECRUITING
PHASE3
65 participants
INTERVENTIONAL
2024-04-25
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Healthy Diet + Eggs (HD+E)
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal
Whole Egg
Whole Large, Grade A Egg
Healthy Diet (HD)
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)
Whole Egg
Whole Large, Grade A Egg
Interventions
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Whole Egg
Whole Large, Grade A Egg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
60 Years
ALL
Yes
Sponsors
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American Egg Board
OTHER
Penn State University
OTHER
Responsible Party
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Kristina Petersen PhD, APD, FAHA
Associate Professor
Principal Investigators
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Kristina Petersen
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Locations
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The Pennylvania State University
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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HDE
Identifier Type: -
Identifier Source: org_study_id
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