Recruiting
Phase 3

Dietary Pattern

Sponsor:

Penn State University

Code:

NCT06120400

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

Interventions

Whole Egg

Study Details

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.

Conditions

Cardiovascular Diseases

Study ID

NCT06120400

Start date

Apr 25, 2024

Status verified date

Jul, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Healthy Diet + Eggs (HD+E)

2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal

active comparator: Healthy Diet (HD)

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

Interventions

Whole Egg

Whole Large, Grade A Egg

Primary outcome measure

  • LDL-cholesterol change [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Kristina Petersen, PhD

814-865-7206kup63@psu.edu

Stacey Meily

814-863-8622sas117@psu.edu

Locations

The Pennylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

866-778-3438DCHLab@psu.edu

More Information

Sponsor

Penn State University

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2025-07-20.