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IRCT201705035623N115 IRCT 2017-05-29 Vice chancellor for research, Kashan University of Medical Sciences Effect of supplementation in treatment of patients with diabetic nephropathy Clinical trial of the effect of probiotic honey supplementation compared with the control honey on metabolic profiles in patients with diabetic nephropathy 2017-03-21 anticipated 60 Complete https://irct.ir/trial/6145 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, after balanced blocked randomisation, all participants will have allocated into two treatment groups to take either probiotic honey or normal honey. Randomization will be done by the use of Stat Trek software, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 3 Diabetic nephropathy. Intervention 1: Control group: 25 g control honey (Sekkeh Gaz, Isfahan, Iran), once a day, for 12 weeks orally. Intervention 2: Intervention group: 25 g probiotic honey (Sekkeh Gaz, Isfahan, Iran), 108 Lactobacillus sporogenes CFU/g, once a day, for 12 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available.
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic nephropathy Aged 40 to 80 years Proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels 45 years 85 years Both History of active infection within 3 months The intake of probiotic and/or synbiotic supplements within 3 months Malignancy and/or liver cirrhosis N08.3 Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+) Treatment - Drugs Treatment - Drugs Control group: 25 g control honey (Sekkeh Gaz, Isfahan, Iran), once a day, for 12 weeks orally. Intervention group: 25 g probiotic honey (Sekkeh Gaz, Isfahan, Iran), 108 Lactobacillus sporogenes CFU/g, once a day, for 12 weeks orally. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. FPG. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Vice chancellor for research, Kashan University of Medical Sciences Approved 2017-03-07 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)