]>
IRCT20110530006652N3 IRCT 2020-04-16 Nutrition Research Center, Tabriz University of medical Sciences, Tabriz, Iran The effects of okra (Abelmoschus esculentus) fruit dried extract on kidney function in diabetic nephropathic patients The effects of okra (Abelmoschus esculentus) fruit dried extract on several genes expression, serum metabolic, oxidative stress, and autophagy- related parameters, anthropometric indices, appetite, and kidney function in diabetic nephropathic patients 2020-06-21 anticipated 50 Complete https://irct.ir/trial/44624 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: At the beginning of the study, the eligibility criteria including BMI, age, and gender will be matched by blocking method. Sixty subjects with diabetic nephropathy will be randomly assigned into either intervention group (okra recipient) or control group (carboxymethyl cellulose recipient), using RAS software, Blinding description: After randomization, the dried extract of okra will be allocated into the supplement group and carboxymethyl cellulose will be given to the placebo group as a capsule. The capsules will be filled without the involvement of the researchers and will be numbered as 1 and 2 codes. The nutrition expert will introduce the capsules with either code 1 or code 2. Until the release of the study results, neither the patients nor the researchers or doctors and statistician will not be informed of the allocated codes. The numbers will be decoded at the study end-point. Therefore, the study will be triple-blinded. 3 Diabetic Nephropathy. Intervention 1: Control group: In this study, patients in the placebo group will receive one capsule containing 125 mg carboxymethyl cellulose for 10 weeks. Diet evaluation will be performed using a 24-hour three-day food record questionnaire (including two mid-week days and one weekend day) at baseline and at the end of the tenth week. Patients will be instructed to refrain from any change in diet, physical activity, type or dosage of their medications during the study. Otherwise, they will be excluded from the study. Patients will be followed up every two weeks by phone call so as to control the use of the placebo and prevent any drop-out . Patients will also be asked to bring the bottle of remaining capsules with them at the second visit. If a patient consumes less than 90% of the capsules, he/ she will be excluded from the study. Intervention 2: Intervention group: In this study, patients in the intervention group will receive one capsule containing 125 mg dried okra extract for 10 weeks. Diet evaluation will be performed using a 24-hour three-day food record questionnaire (including two mid-week days and one weekend day) at baseline and at the end of the tenth week. Patients will be instructed to refrain from any change in diet, physical activity, type or dosage of their medications during the study. Otherwise, they will be excluded from the study. Patients will be followed up every two weeks by phone call so as to control the use of the supplements and prevent any drop-out. Patients will also be asked to bring the bottle of remaining capsules with them at the second visit. If a patient consumes less than 90% of the capsules, he/ she will be excluded from the study. Yes - There is a plan to make this available What will be shared: Publish results When: After finishing and publishing the project article To whom: University researchers Conditions: With permission from Project Researcher and Project Supporting Organization - Nutrition Research Center and Research Deputy Where to obtain: Dr Maryam Saghafi Asl-Tabriz University of Medical Sciences, School of Nutrition and Nutrition, Email: Saghafiaslm@gmail.com How to obtain: The recipient can send an application to the study subject via email. Comments:
public omid nikpayam
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Nishabouri Ave., Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 33357581 nikpayamomid@gmail.com Tabriz University of Medical Sciences scientific Dr. Maryam Saghafi Asl
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Tabriz
Tabriz Iran (Islamic Republic of) 516665931 +98 33357581 Saghafiaslm@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) BMI ≥25 kg / m2 and BMI <38kg / m2 Age: 40 to 70 years Excretion of protein greater than 0.3 g in 24-hour urine for more than 3 months Willingness to participate in the study 40 years 70 years Both Weekly consumption of okra over the past three months Pregnancy and lactation Other Kidney Diseases, Liver Disease, Thyroid disorders and Inflammatory Diseases, Cancer, NSAIDS consumption and so on. Energy intake less than 800 or more than 4,200 kcal per day based on a three-day feed record questionnaire Following unusual weight-loss regimens 3 months before the enrollment (like water treatment, single food eating, Canadian diet, ...) People taking warfarin or other anti-coagulants Cardiovascular Disease (Stages 2 and 3) Uncontrolled diabetes mellitus (HbA1c>8) E08.21 diabetic nephropathy Placebo Treatment - Other Control group: In this study, patients in the placebo group will receive one capsule containing 125 mg carboxymethyl cellulose for 10 weeks. Diet evaluation will be performed using a 24-hour three-day food record questionnaire (including two mid-week days and one weekend day) at baseline and at the end of the tenth week. Patients will be instructed to refrain from any change in diet, physical activity, type or dosage of their medications during the study. Otherwise, they will be excluded from the study. Patients will be followed up every two weeks by phone call so as to control the use of the placebo and prevent any drop-out . Patients will also be asked to bring the bottle of remaining capsules with them at the second visit. If a patient consumes less than 90% of the capsules, he/ she will be excluded from the study. Intervention group: In this study, patients in the intervention group will receive one capsule containing 125 mg dried okra extract for 10 weeks. Diet evaluation will be performed using a 24-hour three-day food record questionnaire (including two mid-week days and one weekend day) at baseline and at the end of the tenth week. Patients will be instructed to refrain from any change in diet, physical activity, type or dosage of their medications during the study. Otherwise, they will be excluded from the study. Patients will be followed up every two weeks by phone call so as to control the use of the supplements and prevent any drop-out. Patients will also be asked to bring the bottle of remaining capsules with them at the second visit. If a patient consumes less than 90% of the capsules, he/ she will be excluded from the study. Fasting blood glucose. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: enzymatic colorimetric. HBA1c. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: chromatography. Serum insulin. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: ELISA kit. Homeostatic model assessment of insulin resistance. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: calculating with formula. LDL-C. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: calculating with formula. HDL-C. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Total cholesterol. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Triglyceride. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Serum Albumin. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Serum creatinine. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Blood urea nitrogen. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Urine Total Protein. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Urine creatinine. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Serum malondialdehyde. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Serum glitathione peroxidase. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Advanced glycation end products. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Soluble receptor for advanced glycation end products. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: laboratory kit. Serum nitric oxide. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: ELISA. Hs-CRP. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: ELISA. Gene expression of interleukin-1beta. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of glucagon like peptide. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Serum dipeptidyl peptidase-4. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: ELISA. Gene expression of receptor advanced glycation end products. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of ICAM. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Peroxisome proliferator–activated receptor-γ. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Peroxisome proliferator–activated receptor-α. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of NF-E2-related factor 2 (NRF-2). Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of Pentraxin-3. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of Transforming growth factor beta. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Serum level of mTOR. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Elisa. Serum level of SIRT-1. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Elisa. Serum level of Beclin-1. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Elisa. Gene expression of Autophagy Related gene 5. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of LC-3. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of Unc-51 Like Autophagy Activating Kinase 1. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Gene expression of Beclin-1. Timepoint: at baseline and 10 weeks after intervention. Method of measurement: Real time - PCR. Weight. Timepoint: At baseline and three months after. Method of measurement: Digital Scales. Waist. Timepoint: At baseline and three months after. Method of measurement: Non-elastic meter. Blood pressure. Timepoint: At baseline and three months after. Method of measurement: Blood pressure Monitor. Body fat percent. Timepoint: At baseline and three months after. Method of measurement: body composition devise. Lean body mass percent. Timepoint: At baseline and three months after. Method of measurement: body composition devise. Appetite. Timepoint: At baseline and three months after. Method of measurement: questionnaire. Tabriz University of Medical Sciences Tabriz University of Medical Sciences Tabriz University of Medical Sciences Approved 2019-11-11 Ethics committee of Tabriz University of Medical Sciences Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)