Objective: This study examined the effect of Saffron consumption in comparison with placebo on Glycemic status, lipid profile, nephropathy, fat body percent and some blood biochemical parameters in type 2 Diabetic Patients. Design of study: Randomized, double blind, placebo controlled, single center and phase 2-3 trial.The patients, executive researcher and the chief colleague will not aware of allocation of patients to intervention and control groups. Setting and conduct: 90 diabetic Patients according to specialist diagnosis from clinics of Iran University of Medical Sciences will be enrolled.They will be divided in 2 groups based on random numbers table; Intervention group and placebo group. Intervention group will receive one pill of Saffron and placebo group will receive placebo pill. Participants inclusion and major eligibility criteria: Type 2 Diabetic adults with completed informed consent form and 30-70 years ages will be included in the study.
Major exclusion criteria: Insulin consumption, reluctance for continuing the cooperation, taking less than 80% of supplements given to patients at baseline(the compliance lower than 80%) will be excluded participants from study.
Intervention groups: patients in case group will receive one Pill containing 100 mg Powder of Saffron daily with meal and placebo patients will receive one pill containing 100 mg Maltodextrin daily with meal for 3 months. Before and after the 3 months intervention periods, glycemic index(HbA1c, FBS, Insulin), lipid profile(HDL-C, TG, LDL-C, TC )and biochemical criteria including Inflammatory indices(TNF-a, hs-CRP), Total antioxidant capacity, Indicator of oxidative stress( MDA) And nephropathy indices(albuminuria , BUN, Cr), liver enzymes(ALT,AST) in two groups will be compared. Waist circumference and BMI, body fat percent, blood pressure will be assessed too. For Dietary assessment of patients and control potential confounding factors of diet, 3-day dietary recall questionnaire and physical activity questionnaire(IPAQ) will be used.