Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Dec:8:90-98.
doi: 10.1016/j.conctc.2017.09.003. Epub 2017 Sep 14.

The Effect of a Vegan versus AHA DiEt in Coronary Artery Disease (EVADE CAD) trial: study design and rationale

Binita Shah  1   2 , Lisa Ganguzza  1 , James Slater  1 , Jonathan D Newman  1 , Nicole Allen  1 , Edward Fisher  1 , John Larigakis  1 , Francisco Ujueta  1 , Eugenia Gianos  1 , Yu Guo  3 , Kathleen Woolf  4
Affiliations

The Effect of a Vegan versus AHA DiEt in Coronary Artery Disease (EVADE CAD) trial: study design and rationale

Binita Shah et al. Contemp Clin Trials Commun. 2017 Dec.

Abstract

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-hour 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.

Keywords: Diet intervention; coronary artery disease; glucose; inflammation; lipids.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Treatment self-regulation questionnaire. Questions 1 through 6 assess autonomous regulation; questions 7 through 12 assess controlled regulation; and questions 13 through 14 assess amotivation. Patients were excluded if they give an answer of >4 to any of the amotivational items or if the relative autonomy index (defined as average of answers for the first 6 autonomous items – average of answers for the second 6 controlled items) is <0.
Fig. 2
Fig. 2
Four-day food record.
See this image and copyright information in PMC

References

    1. Packard R.R., Libby P. Inflammation in atherosclerosis: from vascular biology to biomarker discovery and risk prediction. Clin. Chem. 2008;54:24–38. - PubMed
    1. Nidorf M., Thompson P.L. Effect of colchicine (0.5 mg twice daily) on high-sensitivity C-reactive protein independent of aspirin and atorvastatin in participants with stable coronary artery disease. Am. J. Cardiol. 2007;99:805–807. - PubMed
    1. Nidorf S.M., Eikelboom J.W., Budgeon C.A. Low-dose colchicine for secondary prevention of cardiovascular disease. J. Am. Coll. Cardiol. 2013;61:404–410. - PubMed
    1. Patti G., Massimo C., Pasceri V., Colonna D., Nusca A., Miglionico M., D'Ambrosio A., Covino E., Di Sciascio G. Protection from procedural myocardial injury by atorvastatin is associated with lower levels of adhesion molecules after percutaneous coronary intervention: results from the ARMYDA-CAMs substudy. J. Am. Coll. Cardiol. 2006;48:1560–1566. - PubMed
    1. Pasceri V., Patti G., Nusca A., Pristipino C., Richichi G., Di Sciascio G. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA study. Circulation. 2004;110:674–678. - PubMed

LinkOut - more resources