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In this randomized study the investigators aim to determine the effects of a whole-food plant-based vegan diet on markers of inflammation and glucometabolic profile in patients with cardiovascular disease. The investigators hypothesize that a whole-food plant-based vegan diet will reduce markers of inflammation and improve glucometabolic profile compared with the American Heart Association (AHA)- recommended diet at 2 months follow-up in patients with coronary artery disease (CAD). The investigators are also evaluating endothelial function using the EndoPAT device and stool microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| American Heart Association diet | Active Comparator | Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks. |
|
| Whole-food plant-based vegan diet | Experimental | Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Behavioral | Whole foods plant based vegan diet vs the American Heart Association-recommended diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in hsCRP from baseline | At 8 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| change in L-selectin from baseline | 4 week and 8 week follow-up | |
| change in body mass index from baseline | 4 week and 8 week follow-up | |
| change in Abdominal Circumference from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binita Shah, MD, MS | NYU SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYUMC Tisch Hospital, HCC 14 | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| 4 week and 8 week follow-up |
| change in Blood Pressure from baseline | 4 week and 8 week follow-up |
| change in CD11b from baseline | 4 week and 8 week follow-up |
| change in Stool microbiome from baseline | 4 and 8 week follow-up |
| change in EndPAT score from baseline | 4 and 8 week follow-up |
| change in Serum amyloid A from baseline | soluble inflammatory marker | 4 week and 8 week follow-up |
| change in TNF-α from baseline | 4 week and 8 week follow-up |
| change in pentraxin-3 from baseline | 4 week and 8 week follow-up |
| change in MMP-9 from baseline | 4 week and 8 week follow-up |
| change in lipid panel from baseline | 4 week and 8 week follow-up |
| change in apolipoprotein B from baseline | 4 week and 8 week follow-up |
| change in fasting blood glucose from baseline | 4 week and 8 week follow-up |
| change in blood insulin from baseline | 4 week and 8 week follow-up |
| change in Hemoglobin a1c from baseline | 4 week and 8 week follow-up |
| change in cell adhesion molecule from baseline | 4 week and 8 week follow-up |
| change in monocyte subtype from baseline | 4 week and 8 week follow-up |
| change in interleukin from baseline | 4 week and 8 week follow-up |
| change in chemokine from baseline | 4 week and 8 week follow-up |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |