Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

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

NCT06120400

HDE

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