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

NYU Langone Health100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Coronary Artery Disease Inflammation

Interventions

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change in hsCRP from baseline

Time frame: At 8 weeks follow-up

Secondary Outcomes

change in L-selectin from baseline

Time frame: 4 week and 8 week follow-up

change in body mass index from baseline

Time frame: 4 week and 8 week follow-up

change in Abdominal Circumference from baseline

Time frame: 4 week and 8 week follow-up

change in Blood Pressure from baseline

Time frame: 4 week and 8 week follow-up

change in CD11b from baseline

Time frame: 4 week and 8 week follow-up

change in Stool microbiome from baseline

Time frame: 4 and 8 week follow-up

change in EndPAT score from baseline

Time frame: 4 and 8 week follow-up

change in Serum amyloid A from baseline

soluble inflammatory marker

Time frame: 4 week and 8 week follow-up

change in TNF-α from baseline

Time frame: 4 week and 8 week follow-up

change in pentraxin-3 from baseline

Time frame: 4 week and 8 week follow-up

change in MMP-9 from baseline

Time frame: 4 week and 8 week follow-up

change in lipid panel from baseline

Time frame: 4 week and 8 week follow-up

change in apolipoprotein B from baseline

Time frame: 4 week and 8 week follow-up

change in fasting blood glucose from baseline

Time frame: 4 week and 8 week follow-up

change in blood insulin from baseline

Time frame: 4 week and 8 week follow-up

change in Hemoglobin a1c from baseline

Time frame: 4 week and 8 week follow-up

change in cell adhesion molecule from baseline

Time frame: 4 week and 8 week follow-up

change in monocyte subtype from baseline

Time frame: 4 week and 8 week follow-up

change in interleukin from baseline

Time frame: 4 week and 8 week follow-up

change in chemokine from baseline

Time frame: 4 week and 8 week follow-up

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes