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IRCT201309243140N13 IRCT 2013-11-16 Vice chancellor for Research, Tabriz University of Medical Sciences The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity The effects of Silybum marianum (L.) Gaertn. (Silymarin) supplement consumption on metabolic status, Hs-CRP and oxidative stress in type 2 diabetic patients with overweight or obesity 2013-10-23 anticipated 40 Complete https://irct.ir/trial/3180 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2-3 Type 2 diabetes. Intervention 1: Intervention group will receive daily 3 tablets of silymarin with meal for 45 days (each tablets of silymarin contains 140 milligrams pure silymarin). silymarin tablets will be purchased from the Livergol ®; Goldaru Herbal Products Pharmaceutical Company. All the patients will receive the tablets on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews and 2-weeks check lists. Intervention 2: The control group will receive daily 3 tablets of placebo with meal for 45 days. (Placebo tablets will be produced at the faculty of pharmacy of Tabriz University of medical sciences).
public Soraiya Ebrahimpour Koujan
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
Tabriz Iran (Islamic Republic of) 00 nutri.seam1@gmail.com Tabriz University of Medical Sciences scientific Bahram Pourghasem Gargary
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
Tabriz Iran (Islamic Republic of) +98 41 1335 7580 bahrampg@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Type 2 diabetes for at least 6 months; age between 20-50 (both of gender) years and usage of blood glucose lowering drugs. Exclusion criteria: usage of nutritional supplements in the past 3 months or during the study; usage of insulin; Pregnancy or lactation; BMI more than 35 and lower than 27; Renal and liver failure; Cardiovascular disease; Thyroid disorders; History of allergy; Smoking; Alcohol usage; Following a specific diet; Taking corticosteroids or Immunosuppressive drugs,… 20 years 50 years Both E10,E11,E1 Non-insulin-dependent diabetes mellitus Treatment - Drugs Placebo Intervention group will receive daily 3 tablets of silymarin with meal for 45 days (each tablets of silymarin contains 140 milligrams pure silymarin). silymarin tablets will be purchased from the Livergol ®; Goldaru Herbal Products Pharmaceutical Company. All the patients will receive the tablets on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews and 2-weeks check lists. The control group will receive daily 3 tablets of placebo with meal for 45 days. (Placebo tablets will be produced at the faculty of pharmacy of Tabriz University of medical sciences). Fasting blood glucose. Timepoint: Baseline and after 45 days of intervention. Method of measurement: Enzymatic colorimetric. Insulin resistance. Timepoint: Baseline and after 45 days of intervention. Method of measurement: HOMA-IR calculation. Fasting insulin serum. Timepoint: Baseline and after 45 days of intervention. Method of measurement: ELISA assay. Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and after 45 days of intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5). Hs-CRP. Timepoint: Baseline and after 45 days of intervention. Method of measurement: immunoturbidimetry. Serum malondialdehyde (MDA). Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. Serum total antioxidant capacity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. GPX activity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. SOD activity. Timepoint: Baseline and after 45 days of intervention. Method of measurement: spectrophotometry. Calorie and nutrients intake. Timepoint: before and after 45 dyas intervention. Method of measurement: 24-h recall Questionnaire. Anthropometric index(weight, height,WHR and Body Mass. Timepoint: before and after 45 days intervention. Method of measurement: Analogue scale for weight and weight(Kg)/Square Height for body mass index. Systolic and diastolic blood pressure. Timepoint: before and after 45 days intervention. Method of measurement: standard barometer. Vice chancellor for Research, Tabriz University of Medical Sciences Approved 2013-09-10 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golbad Street Tabriz Iran (Islamic Republic of)