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Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status and phase

Enrolling
Phase 3

Conditions

Cardiovascular Diseases

Treatments

Drug: Whole Egg

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

65 participants in 2 patient groups

Healthy Diet + Eggs (HD+E)
Experimental group
Description:
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal
Treatment:
Drug: Whole Egg
Healthy Diet (HD)
Active Comparator group
Description:
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)
Treatment:
Drug: Whole Egg

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Stacey Meily; Kristina Petersen, PhD

Data sourced from clinicaltrials.gov

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