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NCT Number: NCT02135939

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYUMC Tisch Hospital, HCC 14

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

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

Other names: Vegan vs AHA-recommended diet

Primary outcomes

  1. change in hsCRP from baseline

    Time frame: At 8 weeks follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 12, 2014
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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