Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: Whole Egg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kristina Petersen, PhD; Phone Number: 814-865-7206; Email: kup63@psu.edu
• Study Contact Backup: Name: Stacey Meily; Phone Number: 814-863-8622; Email: sas117@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Recruiting
      • The Pennylvania State University
      • Contact: Phone Number: 866-778-3438; Email: DCHLab@psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Diet + Eggs (HD+E); 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal	Drug: Whole Egg; Whole Large, Grade A Egg
Active Comparator: Healthy Diet (HD); 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)	Drug: Whole Egg; Whole Large, Grade A Egg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglyceride change	Assessed from fasting blood draw expressed in mg/dL.	4 weeks
Total cholesterol change	Assessed from fasting blood draw expressed in mg/dL.	4 weeks
HDL-cholesterol change	Assessed from fasting blood draw expressed in mg/dL.	4 weeks
LDL-cholesterol to HDL-cholesterol ratio change	LDL-cholesterol and HDL-cholesterol will be measured from a fasting blood draw expressed in mg/dL. The ratio will be calculated as LDL-C divided by HDL-C	4 weeks
Change in particle size and number of LDL, HDL, VLDL and chylomicrons	Measured via Nuclear Magnetic Resonance	4 weeks
Change in central systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Change in brachial systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Change in fasting serum insulin	Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/ml	4 weeks
Change in fasting plasma glucose concentration	Glucose assessed in a fasting blood draw and expressed in mg/dL	4 weeks
Change in Fructosamine	Fructosamine assess in a fasting blood draw and expressed in micro IU/ml	4 weeks
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5	4 weeks
Change in carotid-femoral pulse wave velocity	A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second.	4 weeks
Change in trimethylamine N-oxide (TMAO)	Measured in fasting blood. Expressed as µmol/L	4 weeks
Change in choline	Measured in fasting blood. Expressed as µmol/L	4 weeks
Change in carnitine	Measured in fasting blood. Expressed as µmol/L	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the composition of the gut microbiota	Abundance measured using 16 s rRNA sequencing	4 weeks

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: American Egg Board
• Investigators: Principal Investigator: Kristina Petersen, The Pennsylvania State University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: HDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After publication of all pre-specified primary and secondary outcomes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No