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

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Coronary Artery Disease
Inflammation

Treatments

Behavioral: Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02135939
14-00292

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

American Heart Association diet
Active Comparator group
Description:
Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks.
Treatment:
Behavioral: Diet
Whole-food plant-based vegan diet
Experimental group
Description:
Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks.
Treatment:
Behavioral: Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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