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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Inflammation
• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03-11
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Primary Completion: 2017-03-29
• Study Completion: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-24

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) .

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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

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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