Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Penn State University
• Collaborator: American Egg Board

Criteria

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