RESUMEN
Nigella sativa (N. sativa) is one of important herbal foods in traditional medicine and many studies have conducted to show the effects of this plant on several diseases. The goal of this study was the evaluation of effects of bread with N. Sativa on clinical parameters such as blood glucose, blood pressure (BP) and anthropometry indices in subjects with metabolic syndrome (MetS). A study as double-blind, cross-over, randomized clinical trial was performed in 51 MetS patients in Chalus, north region of Iran. After dividing of patients randomly in 2 groups, in phase 1, intervention group (A, n = 27) used daily a bread with N. sativa and control group (B, n = 24) used the same bread but without N. sativa for 2 months. After considering of 15 day wash out period, phase 2 was began with changing of position of 2 groups. Measuring of parameters including fasting blood glucose (FBG), systolic blood pressure (SBP), diastolic blood pressure (DBP), weight, body mass index (BMI), and waist circumference (WC) was done before and after of 2 phases. After evaluation of treatment, sequence and time effects of intervention on parameters, it is shown that consumption of this bread has not significant treatment effect (as main effect) on FBG, SBP, DBP, WC, weight, and BMI (p > 0.05). Sequence effect on FBG, weight, WC, and BMI was significant (p < 0.05), but was not on BP. Time effect was only significant for DBP. Consumption of bread with N. sativa in MetS patients has not significant effect on FBG, BP, weight, WC, and BMI. TRIAL REGISTRATION: Iranian Registry of Clinical Trials Identifier: IRCT2015041821815N1