Coronary Artery Disease, Inflammation
Conditions
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.
Interventions
BEHAVIORALDiet
Whole foods plant based vegan diet vs the American Heart Association-recommended diet
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in hsCRP from baseline | At 8 weeks follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 4 week and 8 week follow-up | soluble inflammatory marker |
| 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 L-selectin 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 | — |
| change in MMP-9 from baseline | 4 week and 8 week follow-up | — |
Countries
United States
Outcome results
None listed