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

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Inflammation
• Intervention / Treatment: Behavioral: Diet

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYUMC Tisch Hospital, HCC 14

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Binita Shah, MD, MS, NYU SOM

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2014
• Primary Completion (Actual): March 29, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation
• Other Study ID Numbers: 14-00292

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No