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IRCT20230720058857N1 IRCT 2023-07-31 Artesh University of Medical Sciences Effect of Moringa in metabolic syndrome The effect of Moringa oral product on inflammatory factors, insulin resistance and abdominal obesity in military with metabolic syndrome, clinical trial 2023-08-21 anticipated 102 Complete https://irct.ir/trial/71654 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: The type of randomization will be block type. Classification of people based on the age of 18 to 40 and 40 to 60 years, gender (male/female) and BMI (25 to 30 and 30 to 40) has been done using blocks of four (In order to distribute confounders equally in two groups at each time point of the study). Identification codes of patients in the randomized list will be obtained through the site related to random blocks, Blinding description: In order to carry out this research in a double-blind manner, before starting the study, the cans containing the respective pills are coded as A and B by someone other than the researcher, so that the researcher does not know the type of pill received by each group. In addition, the patient himself does not know about the contents of the syrup. 3 Metabolic syndrome. Intervention 1: Intervention group: Military patients with metabolic syndrome taking 2 grams of Moringa supplement daily for 8 weeks. Intervention 2: Control group: Military patients with metabolic syndrome taking 2 grams of placebo daily for 8 weeks. Yes - There is a plan to make this available What will be shared: The protocol article will be published after obtaining the clinical trial code and the intervention article after the completion of the study. When: 6 months after the results are published To whom: Supervisors and adviser Conditions: In order to request journals for the validity of the study and to follow up the study Where to obtain: Mohammad Rashidmayvan Vahid Hadi How to obtain: After the official request in writing or by email, it will be sent within 2 weeks. Comments:
public Mohammad Rashidmayvan
Bahar Ave
Mashhad Iran (Islamic Republic of) 9146997555 +98 51 3854 2140 Rashidmayvan.m@gmu.ac.ir Gonabad University of Medical Sciences scientific Mohammad Rashidmayvan
Bahar ave.
Mashhad Iran (Islamic Republic of) 9146997555 +98 51 3859 1052 Rashidmayvan.m@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) Age between 20-60 years old - no specific underlying disease (such as malignancy, kidney and liver failure) - no pregnancy or breastfeeding - no allergy to moringa food product - no smoking and alcohol consumption -Completion of the consent form and interest in participating in the study - Waist circumference above 80 cm in women and above 94 cm in men (the main criterion of IDF) - Having the criteria of metabolic syndrome (according to the International Diabetes Federation) 20 years 60 years Both 66 E-66 Prevention Placebo Intervention group: Military patients with metabolic syndrome taking 2 grams of Moringa supplement daily for 8 weeks. Control group: Military patients with metabolic syndrome taking 2 grams of placebo daily for 8 weeks. Tumor necrosis factor-alpha. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. High sensitive C reactive protein. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. Erythrocyte sedimentation rate. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. Interleukin 6. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. Malondialdehyde. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. Insulin. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. Glycated Hemoglobin. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. Homeostatic Model Assessment for Insulin Resistance. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Blood sample. Body fat percentage. Timepoint: At the beginning of the study and 8 weeks after starting the Moringa supplement. Method of measurement: Body analyzer. Artesh University of Medical Sciences Approved 2023-06-18 دانشگاه علوم پزشکی ارتش جمهوری اسلامی ایران (کمیته اخلاق در پژوهش) Shahid Etemadzadeh St, West Fatemi St, Tehran Tehran Tehran Iran (Islamic Republic of)