NCT02135939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

May 7, 2014

Last Update Submit

April 23, 2018

Conditions

Coronary Artery DiseaseInflammation

Outcome Measures

Primary Outcomes (1)

  • change in hsCRP from baseline

    At 8 weeks follow-up

Secondary Outcomes (20)

  • change in L-selectin from baseline

    4 week and 8 week follow-up

  • change in body mass index from baseline

    4 week and 8 week follow-up

  • change in Abdominal Circumference from baseline

    4 week and 8 week follow-up

  • change in Blood Pressure from baseline

    4 week and 8 week follow-up

  • change in CD11b from baseline

    4 week and 8 week follow-up

  • +15 more secondary outcomes

Study Arms (2)

American Heart Association diet

ACTIVE COMPARATOR

Participants randomized into this arm will follow an American Heart Association diet plan for 8 weeks.

Behavioral: Diet

Whole-food plant-based vegan diet

EXPERIMENTAL

Participants randomized into this arm will be asked to follow a whole-food plant-based vegan diet plan for 8 weeks.

Behavioral: Diet

Interventions

DietBEHAVIORAL

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

Also known as: Vegan vs AHA-recommended diet
American Heart Association dietWhole-food plant-based vegan diet

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYUMC Tisch Hospital, HCC 14

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseInflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Binita Shah, MD, MS

    NYU SOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 12, 2014

Study Start

March 11, 2014

Primary Completion

March 29, 2017

Study Completion

March 1, 2018

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

US(1)