Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
- Registration Number
- NCT06120400
- Lead Sponsor
- Penn State University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Healthy Diet (HD) Whole Egg 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD) Healthy Diet + Eggs (HD+E) Whole Egg 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal
- Primary Outcome Measures
Name Time Method LDL-cholesterol change 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 Outcome Measures
Name Time Method Change in fasting serum insulin 4 weeks Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/ml
Change in fasting plasma glucose concentration 4 weeks Glucose assessed in a fasting blood draw and expressed in mg/dL
LDL-cholesterol to HDL-cholesterol ratio change 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
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) 4 weeks Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5
Change in carnitine 4 weeks Measured in fasting blood. Expressed as µmol/L
Triglyceride change 4 weeks Assessed from fasting blood draw expressed in mg/dL.
Change in central systolic and diastolic blood pressure 4 weeks Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Change in brachial systolic and diastolic blood pressure 4 weeks Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Total cholesterol change 4 weeks Assessed from fasting blood draw expressed in mg/dL.
HDL-cholesterol change 4 weeks Assessed from fasting blood draw expressed in mg/dL.
Change in particle size and number of LDL, HDL, VLDL and chylomicrons 4 weeks Measured via Nuclear Magnetic Resonance
Change in Fructosamine 4 weeks Fructosamine assess in a fasting blood draw and expressed in micro IU/ml
Change in carotid-femoral pulse wave velocity 4 weeks A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second.
Change in trimethylamine N-oxide (TMAO) 4 weeks Measured in fasting blood. Expressed as µmol/L
Change in choline 4 weeks Measured in fasting blood. Expressed as µmol/L
Trial Locations
- Locations (1)
The Pennylvania State University
🇺🇸University Park, Pennsylvania, United States