The Effects of Nigella Sativa Extract Oil Supplementation on Plasma Level of ICAM-1, VCAM-1, Metabolic and Oxidative Parameters and Nutritional Status in Patients With Coronary Artery Disease: Study Protocol for A Double-Blind, Randomized Controlled Trial

Abstract Background: endothelial and metabolic dysfunction are the main risk factors for atherosclerosis, which eventually leads to cardiovascular diseases, such as coronary artery disease (CAD). However, it has been shown that increased inflammation and oxidative stress play an essential role in this process. Nigella sativa may affect declining atherosclerosis and CAD by reducing inflammation and improving vascular function.Methods: Two sections that are presented in this article include; first, a review of recent findings related to cardiovascular disease, CAD, and their association with N. sativa supplementation. Secondly, we will illustrate a randomized, double-blind clinical trial in 46 Iranian adults with CAD. The subjects (age: 35-65, proof of 50% stenosis in at least one of their major coronary arteries in angiography) will be selected by a simple random sampling method and will be assigned to two months supplementation of N. sativa extract oil or placebo group. The primary outcome is the inflammatory and oxidative variables. The secondary outcomes measures include lipid profile, quality of life, depression, and anthropometric indices. The data will be equated within and between groups using appropriate statistical methods. Discussion: The result of this trial will offer evidence about the efficacy of N. sativa supplementation by improving risk factors related to atherosclerosis and coronary artery disease. Trial registration: Iranian clinical trial registry: IRCT20190506043494N1, Date of registration: November 8, 2019.