Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: Whole Egg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Diet + Eggs (HD+E)<br>2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal | Drug: Whole Egg<br>* Whole Large, Grade A Egg<br>|
| Active Comparator: Healthy Diet (HD)<br>2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD) | Drug: Whole Egg<br>* Whole Large, Grade A Egg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol change | 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). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride change | Assessed from fasting blood draw expressed in mg/dL. | 4 weeks | 
| Total cholesterol change | Assessed from fasting blood draw expressed in mg/dL. | 4 weeks | 
| HDL-cholesterol change | Assessed from fasting blood draw expressed in mg/dL. | 4 weeks | 
| LDL-cholesterol to HDL-cholesterol ratio change | 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 | 4 weeks | 
| Change in particle size and number of LDL, HDL, VLDL and chylomicrons | Measured via Nuclear Magnetic Resonance | 4 weeks | 
| Change in central systolic and diastolic blood pressure | Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) | 4 weeks | 
| Change in brachial systolic and diastolic blood pressure | Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical) | 4 weeks | 
| Change in fasting serum insulin | Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/ml | 4 weeks | 
| Change in fasting plasma glucose concentration | Glucose assessed in a fasting blood draw and expressed in mg/dL | 4 weeks | 
| Change in Fructosamine | Fructosamine assess in a fasting blood draw and expressed in micro IU/ml | 4 weeks | 
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5 | 4 weeks | 
| Change in carotid-femoral pulse wave velocity | A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second. | 4 weeks | 
| Change in trimethylamine N-oxide (TMAO) | Measured in fasting blood. Expressed as µmol/L | 4 weeks | 
| Change in choline | Measured in fasting blood. Expressed as µmol/L | 4 weeks | 
| Change in carnitine | Measured in fasting blood. Expressed as µmol/L | 4 weeks |