Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

NCT ID: NCT06120400

Last Updated: 2025-07-20

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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This is a 2-period, randomized, crossover, controlled feeding study examining the effect of 2020-2025 Dietary Guidelines for Americans adherent dietary patterns containing 2 eggs/day/2000 kcal (HD+E) compared to 3 eggs/week/2000 kcal (HD) on biomarkers of cardiovascular health and function after 4 weeks.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Whole Egg

Intervention Type DRUG

Whole Large, Grade A Egg

Healthy Diet (HD)

2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)

Group Type ACTIVE_COMPARATOR

Whole Egg

Intervention Type DRUG

Whole Large, Grade A Egg

Interventions

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Whole Egg

Whole Large, Grade A Egg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Egg Board

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Kristina Petersen PhD, APD, FAHA

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristina Petersen, PhD

Role: CONTACT

814-865-7206

Stacey Meily

Role: CONTACT

814-863-8622

Facility Contacts

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Role: primary

866-778-3438

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HDE

Identifier Type: -

Identifier Source: org_study_id

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