Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

Official title

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

Overview

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.

Detailed 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.

Interventions

• Drug Whole Egg
  Whole Large, Grade A Egg

Primary outcome measures

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

Secondary outcome measures (12)

• Triglyceride change [Time frame: 4 weeks]
• Total cholesterol change [Time frame: 4 weeks]
• HDL-cholesterol change [Time frame: 4 weeks]
• LDL-cholesterol to HDL-cholesterol ratio change [Time frame: 4 weeks]
• Change in particle size and number of LDL, HDL, VLDL and chylomicrons [Time frame: 4 weeks]
• Change in central systolic and diastolic blood pressure [Time frame: 4 weeks]
• Change in brachial systolic and diastolic blood pressure [Time frame: 4 weeks]
• Change in fasting serum insulin [Time frame: 4 weeks]
• Change in fasting plasma glucose concentration [Time frame: 4 weeks]
• Change in Fructosamine [Time frame: 4 weeks]
• Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Time frame: 4 weeks]
• Change in carotid-femoral pulse wave velocity [Time frame: 4 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 1 center

• The Pennylvania State University — University Park

Identifiers

NCT: NCT06120400 · HDE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗