Back to results

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

Primary Purpose

Coronary Artery Disease, Inflammation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NYUMC Tisch Hospital, HCC 14

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

American Heart Association diet

Whole-food plant-based vegan diet

Arm Description

Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks.

Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks.

Outcomes

Primary Outcome Measures

change in hsCRP from baseline

Secondary Outcome Measures

change in L-selectin from baseline

change in body mass index from baseline

change in Abdominal Circumference from baseline

change in Blood Pressure from baseline

change in CD11b from baseline

change in Stool microbiome from baseline

change in EndPAT score from baseline

change in Serum amyloid A from baseline

soluble inflammatory marker

change in TNF-α from baseline

change in pentraxin-3 from baseline

change in MMP-9 from baseline

change in lipid panel from baseline

change in apolipoprotein B from baseline

change in fasting blood glucose from baseline

change in blood insulin from baseline

change in Hemoglobin a1c from baseline

change in cell adhesion molecule from baseline

change in monocyte subtype from baseline

change in interleukin from baseline

change in chemokine from baseline

Full Information

NCT ID

NCT02135939

First Posted

May 7, 2014

Last Updated

April 23, 2018

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02135939

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

March 11, 2014 (Actual)

Primary Completion Date

March 29, 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

American Heart Association diet

Arm Type

Active Comparator

Arm Description

Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks.

Arm Title

Whole-food plant-based vegan diet

Arm Type

Experimental

Arm Description

Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Diet

Other Intervention Name(s)

Vegan vs AHA-recommended diet

Intervention Description

Whole foods plant based vegan diet vs the American Heart Association-recommended diet

Primary Outcome Measure Information:

Title

change in hsCRP from baseline

Time Frame

At 8 weeks follow-up

Secondary Outcome Measure Information:

Title

change in L-selectin from baseline

Time Frame

4 week and 8 week follow-up

Title

change in body mass index from baseline

Time Frame

4 week and 8 week follow-up

Title

change in Abdominal Circumference from baseline

Time Frame

4 week and 8 week follow-up

Title

change in Blood Pressure from baseline

Time Frame

4 week and 8 week follow-up

Title

change in CD11b from baseline

Time Frame

4 week and 8 week follow-up

Title

change in Stool microbiome from baseline

Time Frame

4 and 8 week follow-up

Title

change in EndPAT score from baseline

Time Frame

4 and 8 week follow-up

Title

change in Serum amyloid A from baseline

Description

soluble inflammatory marker

Time Frame

4 week and 8 week follow-up

Title

change in TNF-α from baseline

Time Frame

4 week and 8 week follow-up

Title

change in pentraxin-3 from baseline

Time Frame

4 week and 8 week follow-up

Title

change in MMP-9 from baseline

Time Frame

4 week and 8 week follow-up

Title

change in lipid panel from baseline

Time Frame

4 week and 8 week follow-up

Title

change in apolipoprotein B from baseline

Time Frame

4 week and 8 week follow-up

Title

change in fasting blood glucose from baseline

Time Frame

4 week and 8 week follow-up

Title

change in blood insulin from baseline

Time Frame

4 week and 8 week follow-up

Title

change in Hemoglobin a1c from baseline

Time Frame

4 week and 8 week follow-up

Title

change in cell adhesion molecule from baseline

Time Frame

4 week and 8 week follow-up

Title

change in monocyte subtype from baseline

Time Frame

4 week and 8 week follow-up

Title

change in interleukin from baseline

Time Frame

4 week and 8 week follow-up

Title

change in chemokine from baseline

Time Frame

4 week and 8 week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Binita Shah, MD, MS

Organizational Affiliation

NYU SOM

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYUMC Tisch Hospital, HCC 14

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs