Cardiovascular Diseases
Conditions
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.
Interventions
DRUGWhole Egg
Whole Large, Grade A Egg
Sponsors
Penn State University
American Egg Board
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride change | 4 weeks | Assessed from fasting blood draw expressed in mg/dL. |
| 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. |
| 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 particle size and number of LDL, HDL, VLDL and chylomicrons | 4 weeks | Measured via Nuclear Magnetic Resonance |
| 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) |
| 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 |
| Change in Fructosamine | 4 weeks | Fructosamine assess in a fasting blood draw and expressed in micro IU/ml |
| 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 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 |
| Change in carnitine | 4 weeks | Measured in fasting blood. Expressed as µmol/L |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKristina Petersen
The Pennsylvania State University
Outcome results
None listed