Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy Diet + Eggs (HD+E) 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal |
Drug: Whole Egg
Whole Large, Grade A Egg
|
| Active Comparator: Healthy Diet (HD) 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD) |
Drug: Whole Egg
Whole Large, Grade A Egg
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- Change in the composition of the gut microbiota [4 weeks]
Abundance measured using 16 s rRNA sequencing
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Penn State University
- American Egg Board
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HDE