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| Name | Class |
|---|---|
| American Egg Board | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Diet + Eggs (HD+E) | Experimental | 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal |
|
| Healthy Diet (HD) | Active Comparator | 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Egg | Drug | Whole Large, Grade A Egg |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the composition of the gut microbiota | Abundance measured using 16 s rRNA sequencing | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Petersen, PhD | Contact | 814-865-7206 | kup63@psu.edu | |
| Stacey Meily | Contact | 814-863-8622 | sas117@psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristina Petersen | The Pennsylvania State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennylvania State University | Recruiting | University Park | Pennsylvania | 16802 | United States |
De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
After publication of all pre-specified primary and secondary outcomes
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2024 | Apr 11, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 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 |