Clinical trial NCT02135939: Vegan vs AHA Diet on Inflammation and Glucometabolic Profile in Patients With CAD
Official title: Effects of a Whole-food Plant-based Vegan Diet on Markers of Inflammation and Glucometabolic Profile in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Inflammation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change in hsCRP from baseline
timeFrame: At 8 weeks follow-up
Secondary outcomes:
measure: change in L-selectin from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in body mass index from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in Abdominal Circumference from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in Blood Pressure from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in CD11b from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in Stool microbiome from baseline
timeFrame: 4 and 8 week follow-up
measure: change in EndPAT score from baseline
timeFrame: 4 and 8 week follow-up
measure: change in Serum amyloid A from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in TNF-α from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in pentraxin-3 from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in MMP-9 from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in lipid panel from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in apolipoprotein B from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in fasting blood glucose from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in blood insulin from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in Hemoglobin a1c from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in cell adhesion molecule from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in monocyte subtype from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in interleukin from baseline
timeFrame: 4 week and 8 week follow-up
measure: change in chemokine from baseline
timeFrame: 4 week and 8 week follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: NYUMC Tisch Hospital, HCC 14
state: New York
Study officials:
affiliation: NYU SOM
name: Binita Shah, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: