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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135939
• Other study ID #: 14-00292
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: April 23, 2018
• Start date: March 11, 2014
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Inflammation
• Myocardial Ischemia

Intervention

Behavioral:
• Diet
Whole foods plant based vegan diet vs the American Heart Association-recommended diet

Locations

Country	Name	City	State
United States	NYUMC Tisch Hospital, HCC 14	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in hsCRP from baseline		At 8 weeks follow-up
Secondary	change in L-selectin from baseline		4 week and 8 week follow-up
Secondary	change in body mass index from baseline		4 week and 8 week follow-up
Secondary	change in Abdominal Circumference from baseline		4 week and 8 week follow-up
Secondary	change in Blood Pressure from baseline		4 week and 8 week follow-up
Secondary	change in CD11b from baseline		4 week and 8 week follow-up
Secondary	change in Stool microbiome from baseline		4 and 8 week follow-up
Secondary	change in EndPAT score from baseline		4 and 8 week follow-up
Secondary	change in Serum amyloid A from baseline	soluble inflammatory marker	4 week and 8 week follow-up
Secondary	change in TNF-a from baseline		4 week and 8 week follow-up
Secondary	change in pentraxin-3 from baseline		4 week and 8 week follow-up
Secondary	change in MMP-9 from baseline		4 week and 8 week follow-up
Secondary	change in lipid panel from baseline		4 week and 8 week follow-up
Secondary	change in apolipoprotein B from baseline		4 week and 8 week follow-up
Secondary	change in fasting blood glucose from baseline		4 week and 8 week follow-up
Secondary	change in blood insulin from baseline		4 week and 8 week follow-up
Secondary	change in Hemoglobin a1c from baseline		4 week and 8 week follow-up
Secondary	change in cell adhesion molecule from baseline		4 week and 8 week follow-up
Secondary	change in monocyte subtype from baseline		4 week and 8 week follow-up
Secondary	change in interleukin from baseline		4 week and 8 week follow-up
Secondary	change in chemokine from baseline		4 week and 8 week follow-up