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IRCT2015081810181N6 IRCT 2015-10-02 Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Effect of oral hesperidin supplementation on glycemic and lipidemicin risk factors and inflammatory and oxidant markers in type 2 diabetes Assessment of the effect of oral hesperidin supplement on glycemic and lipidemic risk factors, visceral adiposity index, serum levels of oxidant, inflammatory and oxidative DNA damage markers in type 2 diabetic patients: A randomized, double-blind, placebo-controlled clinical trial 2015-09-23 anticipated 64 Complete https://irct.ir/trial/10641 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In this double blind study neither the patients nor administering the treatment know which capsules are being received. diabetic patients woul be randomly allocated to the supplement or placebo groups using random number tables. 2 Diabetes. Intervention 1: oral Hesperidin, 600 mg , one capsule per day for 6 weeks. Intervention 2: oral placebo, 600 mg , one capsule per day for 6 weeks.
public Fatemeh Haidari
Golestan Ave. Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Ahvaz
Ahvaz Iran (Islamic Republic of) +98 61 3373 8330 haidari58@gmail.com Dept. of Nutrition, School of Paramedical scientific Fatemeh haidari
Golestan Ave. Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Ahvaz
Ahvaz Iran (Islamic Republic of) +98 61 3373 8330 haidari58@gmail.com Dept. of Nutrition, School of Paramedical Iran (Islamic Republic of) inclusion criteria: having type 2 diabetes for at least 3 years, oral hypoglycemic medications consumption and having informed written consent exclusion criteria: any change in type or dose of drug during the last 3 months, BMI ranges above 30, having history of other endocrine disorders, heart, hepatic and kidney diseases,using steroid drugs or hormones, having vitamin or mineral supplementation during previous 3 month 25 years 60 years Both E10, E11, Diabetes mellitus Treatment - Other Treatment - Other oral Hesperidin, 600 mg , one capsule per day for 6 weeks oral placebo, 600 mg , one capsule per day for 6 weeks Viseral Adiposity Index. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: calculating by formula. Fasting Glucose. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum Glucose concentration in mg/dl by kit. Insulin. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum Insulin concentration in µU/ml by kit. Serum Fructosamine. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum Fructosamine concentration in µmol/L by kit. Serum cholestrol. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting Serum cholestrol concentration in mg/dl by kit. HDL Cholestrol. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting Serum HDL Cholestrol concentration in mg/dl by kit. LDL Cholestrol. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting Serum HDL Cholestrol concentration in mg/dl, calculating by Friedewald formula. Serum Teriglycerid. Timepoint: Baseline, 6 weeks after intervention period. Method of measurement: Fasting serum Teriglycerid concentration in mg/dl by kit. TNF-α. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum TNF-α concentration in ng/L by kit. IL-6. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum IL-6 concentration in ng/L by kit. Hs- CRP. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: serum hs- CRP concentration in mg/L by kit. Total Antioxidant Capacity. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum Total Antioxidant Capacity in U/ml by kit. Serum malondialdehyde. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum malondialdehyde concentration in µmol/ml by kit. 8OHdG. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: Fasting serum 8OHdG concentration (mg/dl) by kit. Body Mass Index. Timepoint: baseline, 6 weeks after intervention period. Method of measurement: body weight / hight square (kg/m2). Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Approved 2015-07-25 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan Ave. Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Ahvaz Ahvaz Iran (Islamic Republic of)