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

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ClinicalTrials.gov Identifier: NCT02135939
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Inflammation Behavioral: Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Whole-food Plant-based Vegan Diet on Markers of Inflammation and Glucometabolic Profile in Patients With Coronary Artery Disease
Actual Study Start Date : March 11, 2014
Actual Primary Completion Date : March 29, 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Vegan vs AHA-recommended diet




Primary Outcome Measures :
  1. change in hsCRP from baseline [ Time Frame: At 8 weeks follow-up ]

Secondary Outcome Measures :
  1. change in L-selectin from baseline [ Time Frame: 4 week and 8 week follow-up ]
  2. change in body mass index from baseline [ Time Frame: 4 week and 8 week follow-up ]
  3. change in Abdominal Circumference from baseline [ Time Frame: 4 week and 8 week follow-up ]
  4. change in Blood Pressure from baseline [ Time Frame: 4 week and 8 week follow-up ]
  5. change in CD11b from baseline [ Time Frame: 4 week and 8 week follow-up ]
  6. change in Stool microbiome from baseline [ Time Frame: 4 and 8 week follow-up ]
  7. change in EndPAT score from baseline [ Time Frame: 4 and 8 week follow-up ]
  8. change in Serum amyloid A from baseline [ Time Frame: 4 week and 8 week follow-up ]
    soluble inflammatory marker

  9. change in TNF-α from baseline [ Time Frame: 4 week and 8 week follow-up ]
  10. change in pentraxin-3 from baseline [ Time Frame: 4 week and 8 week follow-up ]
  11. change in MMP-9 from baseline [ Time Frame: 4 week and 8 week follow-up ]
  12. change in lipid panel from baseline [ Time Frame: 4 week and 8 week follow-up ]
  13. change in apolipoprotein B from baseline [ Time Frame: 4 week and 8 week follow-up ]
  14. change in fasting blood glucose from baseline [ Time Frame: 4 week and 8 week follow-up ]
  15. change in blood insulin from baseline [ Time Frame: 4 week and 8 week follow-up ]
  16. change in Hemoglobin a1c from baseline [ Time Frame: 4 week and 8 week follow-up ]
  17. change in cell adhesion molecule from baseline [ Time Frame: 4 week and 8 week follow-up ]
  18. change in monocyte subtype from baseline [ Time Frame: 4 week and 8 week follow-up ]
  19. change in interleukin from baseline [ Time Frame: 4 week and 8 week follow-up ]
  20. change in chemokine from baseline [ Time Frame: 4 week and 8 week follow-up ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135939


Locations
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United States, New York
NYUMC Tisch Hospital, HCC 14
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Binita Shah, MD, MS NYU SOM
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02135939    
Other Study ID Numbers: 14-00292
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases