Vegan vs AHA Diet on Inflammation and Glucometabolic Profile in Patients With CAD

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effects of a Whole-food Plant-based Vegan Diet on Markers of Inflammation and Glucometabolic Profile in Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease, Inflammation

Intervention / Treatment
-----------------
* Behavioral: Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects on stable medical therapy for at least 7-10 days post-coronary angiography and found to have CAD (defined as >50% lesion in an artery with >2mm caliber) . Exclusion Criteria: Failure of the Treatment Self-Regulation Questionnaire Use of steroids or non-steroidal anti-inflammatory medications other than aspirin Use of probiotics or over the counter supplements other than standard vitamins Have a history of myocardial infarction or active infection within the preceding 3 months Have a history of an eating disorder or colon cleansing or are already on a whole-food plant-based vegan diet Have a planned PCI during the study period Are participating in a competing study Have any condition or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: American Heart Association diet<br>Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks. | Behavioral: Diet<br>* Whole foods plant based vegan diet vs the American Heart Association-recommended diet<br>* Other names: Vegan vs AHA-recommended diet;|
| Experimental: Whole-food plant-based vegan diet<br>Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks. | Behavioral: Diet<br>* Whole foods plant based vegan diet vs the American Heart Association-recommended diet<br>* Other names: Vegan vs AHA-recommended diet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hsCRP from baseline |  | At 8 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |