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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT02135939
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
47.7
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diet
 N/A

Study Design

Study Type:
Interventional
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 :
Mar 11, 2014
Actual Primary Completion Date :
Mar 29, 2017
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in hsCRP from baseline [At 8 weeks follow-up]

    Secondary Outcome Measures

    1. change in L-selectin from baseline [4 week and 8 week follow-up]

    2. change in body mass index from baseline [4 week and 8 week follow-up]

    3. change in Abdominal Circumference from baseline [4 week and 8 week follow-up]

    4. change in Blood Pressure from baseline [4 week and 8 week follow-up]

    5. change in CD11b from baseline [4 week and 8 week follow-up]

    6. change in Stool microbiome from baseline [4 and 8 week follow-up]

    7. change in EndPAT score from baseline [4 and 8 week follow-up]

    8. change in Serum amyloid A from baseline [4 week and 8 week follow-up]

      soluble inflammatory marker

    9. change in TNF-α from baseline [4 week and 8 week follow-up]

    10. change in pentraxin-3 from baseline [4 week and 8 week follow-up]

    11. change in MMP-9 from baseline [4 week and 8 week follow-up]

    12. change in lipid panel from baseline [4 week and 8 week follow-up]

    13. change in apolipoprotein B from baseline [4 week and 8 week follow-up]

    14. change in fasting blood glucose from baseline [4 week and 8 week follow-up]

    15. change in blood insulin from baseline [4 week and 8 week follow-up]

    16. change in Hemoglobin a1c from baseline [4 week and 8 week follow-up]

    17. change in cell adhesion molecule from baseline [4 week and 8 week follow-up]

    18. change in monocyte subtype from baseline [4 week and 8 week follow-up]

    19. change in interleukin from baseline [4 week and 8 week follow-up]

    20. change in chemokine from baseline [4 week and 8 week follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYUMC Tisch Hospital, HCC 14 New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Binita Shah, MD, MS, NYU SOM

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT02135939
    Other Study ID Numbers:
    • 14-00292
    First Posted:
    May 12, 2014
    Last Update Posted:
    Apr 24, 2018
    Last Verified:
    Apr 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Inflammation

    Study Results

    No Results Posted as of Apr 24, 2018