Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06120400

Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Pennylvania State University

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Egg

Drug

Whole Large, Grade A Egg

Primary outcomes

  1. LDL-cholesterol change

    Time frame: 4 weeks

    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).

Secondary outcomes

  1. Triglyceride change

    Time frame: 4 weeks

    Assessed from fasting blood draw expressed in mg/dL.

  2. Total cholesterol change

    Time frame: 4 weeks

    Assessed from fasting blood draw expressed in mg/dL.

  3. HDL-cholesterol change

    Time frame: 4 weeks

    Assessed from fasting blood draw expressed in mg/dL.

  4. LDL-cholesterol to HDL-cholesterol ratio change

    Time frame: 4 weeks

    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

  5. Change in particle size and number of LDL, HDL, VLDL and chylomicrons

    Time frame: 4 weeks

    Measured via Nuclear Magnetic Resonance

  6. Change in central systolic and diastolic blood pressure

    Time frame: 4 weeks

    Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)

  7. Change in brachial systolic and diastolic blood pressure

    Time frame: 4 weeks

    Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)

  8. Change in fasting serum insulin

    Time frame: 4 weeks

    Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/ml

  9. Change in fasting plasma glucose concentration

    Time frame: 4 weeks

    Glucose assessed in a fasting blood draw and expressed in mg/dL

  10. Change in Fructosamine

    Time frame: 4 weeks

    Fructosamine assess in a fasting blood draw and expressed in micro IU/ml

  11. Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: 4 weeks

    Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5

  12. Change in carotid-femoral pulse wave velocity

    Time frame: 4 weeks

    A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second.

  13. Change in trimethylamine N-oxide (TMAO)

    Time frame: 4 weeks

    Measured in fasting blood. Expressed as µmol/L

  14. Change in choline

    Time frame: 4 weeks

    Measured in fasting blood. Expressed as µmol/L

  15. Change in carnitine

    Time frame: 4 weeks

    Measured in fasting blood. Expressed as µmol/L

Other outcomes

  1. Change in the composition of the gut microbiota

    Time frame: 4 weeks

    Abundance measured using 16 s rRNA sequencing

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Petersen, PhD

CONTACT

[email protected]

814-865-7206

Stacey Meily

CONTACT

[email protected]

814-863-8622

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • American Egg Board

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.