The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationale
Background: Multiple studies demonstrate the benefit of a vegan diet on cardiovascular risk factors when compared to no intervention or usual dietary patterns. The aim of this study is to evaluate the effect of a vegan diet versus the American Heart Association (AHA)-recommended diet on inflammatory...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2017-12-01
|
| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865417300662 |
| _version_ | 1818260055647059968 |
|---|---|
| author | Binita Shah Lisa Ganguzza James Slater Jonathan D. Newman Nicole Allen Edward Fisher John Larigakis Francisco Ujueta Eugenia Gianos Yu Guo Kathleen Woolf |
| author_facet | Binita Shah Lisa Ganguzza James Slater Jonathan D. Newman Nicole Allen Edward Fisher John Larigakis Francisco Ujueta Eugenia Gianos Yu Guo Kathleen Woolf |
| author_sort | Binita Shah |
| collection | DOAJ |
| description | Background: Multiple studies demonstrate the benefit of a vegan diet on cardiovascular risk factors when compared to no intervention or usual dietary patterns. The aim of this study is to evaluate the effect of a vegan diet versus the American Heart Association (AHA)-recommended diet on inflammatory and glucometabolic profiles in patients with angiographically defined coronary artery disease (CAD).
Study design: This study is a randomized, open label, blinded end-point trial of 100 patients with CAD as defined by ≥ 50% diameter stenosis in a coronary artery ≥2 mm in diameter on invasive angiography. Participants are randomized to 8 weeks of either a vegan or AHA-recommended diet (March 2014 and February 2017). Participants are provided weekly groceries that adhere to the guidelines of their diet. The primary endpoint is high sensitivity C-reactive concentrations. Secondary endpoints include anthropometric data, other markers of inflammation, lipid parameters, glycemic markers, endothelial function, quality of life data, and assessment of physical activity. Endpoints are measured at each visit (baseline, 4 weeks, and 8 weeks). Dietary adherence is measured by two weekly 24-h dietary recalls, a 4-day food record during the week prior to each visit, and both plasma and urine levels of trimethylamine-N-oxide at each visit.
Conclusion: This study is the first to comprehensively assess multiple indices of inflammation and glucometabolic profile in a rigorously conducted randomized trial of patients with CAD on a vegan versus AHA-recommended diet. |
| first_indexed | 2024-12-12T18:25:15Z |
| format | Article |
| id | doaj.art-78e8f793087d4710a49a342326d95d4e |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-12T18:25:15Z |
| publishDate | 2017-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-78e8f793087d4710a49a342326d95d4e2022-12-22T00:16:02ZengElsevierContemporary Clinical Trials Communications2451-86542017-12-018C909810.1016/j.conctc.2017.09.003The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationaleBinita Shah0Lisa Ganguzza1James Slater2Jonathan D. Newman3Nicole Allen4Edward Fisher5John Larigakis6Francisco Ujueta7Eugenia Gianos8Yu Guo9Kathleen Woolf10Department of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Medicine (Cardiology), New York University (NYU) School of Medicine, New York, NY, USADepartment of Population Health (Biostatistics), NYU School of Medicine, New York, NY, USADepartment of Nutrition and Food Studies, NYU Steinhardt, New York, NY, USABackground: Multiple studies demonstrate the benefit of a vegan diet on cardiovascular risk factors when compared to no intervention or usual dietary patterns. The aim of this study is to evaluate the effect of a vegan diet versus the American Heart Association (AHA)-recommended diet on inflammatory and glucometabolic profiles in patients with angiographically defined coronary artery disease (CAD). Study design: This study is a randomized, open label, blinded end-point trial of 100 patients with CAD as defined by ≥ 50% diameter stenosis in a coronary artery ≥2 mm in diameter on invasive angiography. Participants are randomized to 8 weeks of either a vegan or AHA-recommended diet (March 2014 and February 2017). Participants are provided weekly groceries that adhere to the guidelines of their diet. The primary endpoint is high sensitivity C-reactive concentrations. Secondary endpoints include anthropometric data, other markers of inflammation, lipid parameters, glycemic markers, endothelial function, quality of life data, and assessment of physical activity. Endpoints are measured at each visit (baseline, 4 weeks, and 8 weeks). Dietary adherence is measured by two weekly 24-h dietary recalls, a 4-day food record during the week prior to each visit, and both plasma and urine levels of trimethylamine-N-oxide at each visit. Conclusion: This study is the first to comprehensively assess multiple indices of inflammation and glucometabolic profile in a rigorously conducted randomized trial of patients with CAD on a vegan versus AHA-recommended diet.http://www.sciencedirect.com/science/article/pii/S2451865417300662Diet interventionCoronary artery diseaseInflammationGlucoseLipids |
| spellingShingle | Binita Shah Lisa Ganguzza James Slater Jonathan D. Newman Nicole Allen Edward Fisher John Larigakis Francisco Ujueta Eugenia Gianos Yu Guo Kathleen Woolf The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationale Contemporary Clinical Trials Communications Diet intervention Coronary artery disease Inflammation Glucose Lipids |
| title | The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationale |
| title_full | The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationale |
| title_fullStr | The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationale |
| title_full_unstemmed | The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationale |
| title_short | The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD) trial: Study design and rationale |
| title_sort | effect of a vegan versus aha diet in coronary artery disease evade cad trial study design and rationale |
| topic | Diet intervention Coronary artery disease Inflammation Glucose Lipids |
| url | http://www.sciencedirect.com/science/article/pii/S2451865417300662 |
| work_keys_str_mv | AT binitashah theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT lisaganguzza theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT jamesslater theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT jonathandnewman theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT nicoleallen theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT edwardfisher theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT johnlarigakis theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT franciscoujueta theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT eugeniagianos theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT yuguo theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT kathleenwoolf theeffectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT binitashah effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT lisaganguzza effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT jamesslater effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT jonathandnewman effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT nicoleallen effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT edwardfisher effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT johnlarigakis effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT franciscoujueta effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT eugeniagianos effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT yuguo effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale AT kathleenwoolf effectofaveganversusahadietincoronaryarterydiseaseevadecadtrialstudydesignandrationale |