Vegan vs AHA Diet on Inflammation and Glucometabolic Profile in Patients With CAD
Not Applicable
Completed
- Conditions
- Coronary Artery DiseaseInflammation
- Interventions
- Behavioral: Diet
- Registration Number
- NCT02135939
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole-food plant-based vegan diet Diet Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks. American Heart Association diet Diet Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks.
- Primary Outcome Measures
Name Time Method change in hsCRP from baseline At 8 weeks follow-up
- Secondary Outcome Measures
Name Time Method change in TNF-α from baseline 4 week and 8 week follow-up change in Serum amyloid A from baseline 4 week and 8 week follow-up soluble inflammatory marker
change in Stool microbiome from baseline 4 and 8 week follow-up change in CD11b 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 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 Hemoglobin a1c from baseline 4 week and 8 week follow-up change in interleukin from baseline 4 week and 8 week follow-up change in L-selectin from baseline 4 week and 8 week follow-up change in Blood Pressure 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 monocyte subtype from baseline 4 week and 8 week follow-up change in Abdominal Circumference from baseline 4 week and 8 week follow-up change in EndPAT score from baseline 4 and 8 week follow-up change in apolipoprotein B 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 chemokine from baseline 4 week and 8 week follow-up change in lipid panel from baseline 4 week and 8 week follow-up change in blood insulin from baseline 4 week and 8 week follow-up
Trial Locations
- Locations (1)
NYUMC Tisch Hospital, HCC 14
🇺🇸New York, New York, United States