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IRCT20191004044979N1 IRCT 2020-09-01 Shiraz University of Medical Sciences advanced glycation end-products on Diabetic Nephropathy Comparison of the effect of advanced glycation end-products restricted diet and combined supplementation of zinc, pyridoxine and curcumin, on kidney functional indices in diabetic nephropathy patients 2019-08-23 anticipated 93 Complete https://irct.ir/trial/42914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomly assigned to one of three groups according to the block-randomization protocol (produced by Random Allocation Software): 1-control 2-intervention (dietary) 3-intervention (pyrodoxin + zinc + curcumin supplement) in 1: 1: 1 fashion. Since allocation sequence is made by computer software and the output is only the list of assigned participant numbers, the research team will not interfere or know how individuals are assigned (randomization and concealment), Blinding description: This study will be conducted in a double-blind manner for more accuracy, so that the researcher is aware of the type of interventions distributed among the study subjects, but the participants and outcome assessor are not aware of the type of intervention applied. Placebo capsules are same in size, color, and odor compared to the intervention capsules, and none of the participants will know which of the three groups they are classified into. Also, outcome assessor has no information about which group the participants were in. 3 Condition 1: Diabetes. Condition 2: Diabetic nephropathy. Intervention 1: Control group: Diabetic diet based on approved guideline of american diabetes association (1500-1800 calorie, 55–65% carbohydrate, ≤30% fat, and 10–20% protein) plus 3 placebo capsules produced by Abu Reyhan company (after each meal- containing non-absorbable starch) for 10 weeks. Intervention 2: Intervention group: Diabetic diet based on approved guideline of american diabetes association (1500-1800 calorie, 55–65% carbohydrate, ≤30% fat, and 10–20% protein) plus 3 placebo capsules produced by Abu Reyhan company (after each meal - containing non-absorbable starch) plus instructions for reducing the amount of advanced glycation end-products compounds in foods based on prior studies for 10 weeks. Intervention 3: Intervention group: Diabetic diet based on approved guideline of american diabetes association (1500-1800 calorie, 55–65% carbohydrate, ≤30% fat, and 10–20% protein) plus 3 capsules containing curcumin (produced by Abu Reyhan company), zinc (produced by Nature Made company) and pyridoxine (produced by Health Aid company), (Totally contains 1 gram of curcumin, 30 mg of zinc, 100 mg of pyridoxine- after each main meal) for 10 weeks. 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 "No more information".
public Arash Dashtabi
School of nutrition and food sciences, Razi blvd
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 1005 arash.dashtabi@yahoo.com Shiraz University of Medical Sciences scientific Zohreh Mazloom
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, IR Iran.
Shiraz Iran (Islamic Republic of) 7134814336 009837251005 zohreh.mazloom@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Diabetes diagnosis by a specialist physician (based on criteria of the American Diabetes Association) Diagnosis of nephropathy by a specialist physician (based on criteria of the American Diabetes Association), patient with a minimum GFR equal to or greater than 30 mL / min / 1.73 m2 and in microalbuminuria (299-30 mg / g Cr) or macroalbuminuria (mg / g Cr) 300≤) No use of alcohol and tobacco Constant weight during the last 6 months (self-report) The constancy of the type and dose of drugs in the past 6 months (self-report) 18 years 65 years Both Occurrence of acute heart disease, stroke, liver or gastrointestinal diseases, thyroid and parathyroid disease, rheumatoid arthritis and infectious Pregnancy or lactation Using any dietary supplement in the past 6 months (self-report) E08.2 E08.21 Diabetes mellitus due to underlying condition with kidney complications Diabetes mellitus due to underlying condition with diabetic nephropathy Placebo Treatment - Other Treatment - Other Control group: Diabetic diet based on approved guideline of american diabetes association (1500-1800 calorie, 55–65% carbohydrate, ≤30% fat, and 10–20% protein) plus 3 placebo capsules produced by Abu Reyhan company (after each meal- containing non-absorbable starch) for 10 weeks Intervention group: Diabetic diet based on approved guideline of american diabetes association (1500-1800 calorie, 55–65% carbohydrate, ≤30% fat, and 10–20% protein) plus 3 placebo capsules produced by Abu Reyhan company (after each meal - containing non-absorbable starch) plus instructions for reducing the amount of advanced glycation end-products compounds in foods based on prior studies for 10 weeks Intervention group: Diabetic diet based on approved guideline of american diabetes association (1500-1800 calorie, 55–65% carbohydrate, ≤30% fat, and 10–20% protein) plus 3 capsules containing curcumin (produced by Abu Reyhan company), zinc (produced by Nature Made company) and pyridoxine (produced by Health Aid company), (Totally contains 1 gram of curcumin, 30 mg of zinc, 100 mg of pyridoxine- after each main meal) for 10 weeks Urine microalbumin. Timepoint: At start and after 10 weeks of intervention. Method of measurement: Biochemical (with special kits made by BIOREX company by immunoturbidometric method). Estimated glomerular filtration rate. Timepoint: Before intervention and 10 weeks after intervention. Method of measurement: The CKD-EPI Creatinine Equation for Glomerular Filtration Rate. Shiraz University of Medical Sciences Approved 2019-09-03 Ethics committee of Shiraz University of Medical Sciences Ethics Committee in Medical Sciences Research - Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences - Seventh Floor - Central Building of Shiraz University of Medical Science - Zand St. Shiraz Fars Iran (Islamic Republic of)