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IRCT20120415009472N23 IRCT 2021-01-02 Vice-chancellor for research Iran University of Medical Sciences Effect of Rosemary (Rosmarinus officinalis) leaves powder in type 2 diabetes patients Effect of Rosemary (Rosmarinus officinalis) leaves powder on glycemic indexes, lipid profile, total antioxidant capacity, SOD, GSH-Px and hs-CRP in patients with type 2 diabetes 2021-04-21 anticipated 90 Complete https://irct.ir/trial/53264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by blocks. According to the sample size of 90 subjects, 15 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug sachets that is generated by the software. Participants will enter based on the sequence produced into study and the drug sachets with code registered will allocate to the individual. Therefore, before participants selection, they will be unaware of the type of intervention that will receive, as well as the researcher, and random sequence produced during the study will be immune from prediction, Blinding description: In order to perform a double-blind study in order to apply concealment in the randomization process, unique codes will be used on the sachets that code will generate by the software. As each individual enters the study, based on the sequence generated, the powder containing the code in which the code is intended will be assigned to the individual, and the rosemary or placebo powder will be coded by a third party who is unaware of the contents of the sachets. Its is randomly divided into two groups by the above method. None of the participants, as well as the researcher, will be aware of the group (rosemary or placebo) that will be included and the type of intervention (rosemary or placebo powder) and the powder containing cartridges as well as the placebo and rosemary cartridges. They will be similar in appearance and exterior. 2 Type 2 diabetes. Intervention 1: Intervention group (n=45): all patients receive relevant dietary recommendations and are asked not to change their diet and physical activity. Also, the participants of the intervention group receive 4 grams of rosemary leaf powder daily in the form of 2 sachets of 2000 mg (2 times a day) for 12 weeks and consume it in yogurt , buttermilk and salad. Rosemary sachets are provided by Green Plants of Life Company. Intervention 2: Control group (n=45): all patients receive relevant dietary recommendations and are asked not to change their diet and physical activity. Also, the participants of the control group receive 4 grams of starch daily in the form of 2 sachets of 2000 mg (2 times a day) for 12 weeks and consume it in yogurt, buttermilk and salad. Starch sachets are provided by Green Plants of Life Company. Yes - There is a plan to make this available What will be shared: Only a section of the data, such as primary outcomes information or the like, will be shared. When: Access period start 6 months after results publishing. To whom: The obtained data from current study will be available only for working researchers in academic and scientific institutions. Conditions: Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis. Where to obtain: Applicants can be communicated to correspond author be e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Highway, Tehran Cell phone: +982186704743 Email: n-aryaeian@sina.tums.ac.ir How to obtain: Publishing in scientific-research journals Applicants will be given access to the obtained data from current study by sending an email to correspond author. Comments:
public Dr Nahid Aryaeian
School of Health, Iran University of Medical Sciences, The intersection of Sheikh Fazlallah and Shahid Chamran, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4750 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences scientific Dr Nahid Aryaeian
ُSchool of Health, Iran University of Medical Sciences, The intersection of Sheikh Fazlallah and Shahid Chamran, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4750 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study and signing of the consent form Diagnosis of type 2 diabetes (fasting blood sugar higher than or equal to 126mg / dl or two hours above 200mg / dl or random blood sugar above 200 with one of the symptoms of hyperglycemia or hyperlipidemia) At least one year of history of diabetes (diagnosis of diabetes based on a doctor's opinion) Serum triglyceride above 200 mg / dl. Age range 25 to 70 years old Their body mass index is 20-35 Do not take any antioxidant and dietary supplements during the last 2 months Not getting pregnant and breastfeeding Do not have other chronic and inflammatory diseases 25 years 70 years Both Smoking and any Drugs Cardiovascular, renal or liver diseases Use any antioxidant and dietary supplement during the last two months Use of Insulin Alcohol consumption Any allergies (gastrointestinal or skin) to any antioxidant or multivitamin supplement E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group (n=45): all patients receive relevant dietary recommendations and are asked not to change their diet and physical activity. Also, the participants of the intervention group receive 4 grams of rosemary leaf powder daily in the form of 2 sachets of 2000 mg (2 times a day) for 12 weeks and consume it in yogurt , buttermilk and salad. Rosemary sachets are provided by Green Plants of Life Company. Control group (n=45): all patients receive relevant dietary recommendations and are asked not to change their diet and physical activity. Also, the participants of the control group receive 4 grams of starch daily in the form of 2 sachets of 2000 mg (2 times a day) for 12 weeks and consume it in yogurt, buttermilk and salad. Starch sachets are provided by Green Plants of Life Company. Fasting Blood Sugar (FBS). Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. Fasting insulin. Timepoint: Before intervention and 12 week after intervention. Method of measurement: ELISA. LDL-C. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. HDL-C. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. Total triglyceride. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. Total cholesterol. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. HOMA- Insulin resistance. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calculation. Quantitative insulin sensitivity check index (QUICKI). Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calculation. High sensitivity C-reactive protein. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Immunoturbidimetric method. Total Antioxidant Capacity. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. Superoxide dismutase (SOD). Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. Glutathione peroxidase (GSH-PX). Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calorie meter method. Weight. Timepoint: Before intervention and 12 week after intervention. Method of measurement: scales. Height. Timepoint: Before intervention and 12 week after intervention. Method of measurement: meter. Waist. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Meter. Body Mass Index (BMI). Timepoint: Before intervention and 12 week after intervention. Method of measurement: Calculation. Systolic blood pressure. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Digital barometric. Diastolic blood pressure. Timepoint: Before intervention and 12 week after intervention. Method of measurement: Digital barometric. Physical activity. Timepoint: Before intervention and 12 week after intervention. Method of measurement: International Physical Activity Questionnaire (IPAQ). Total energy intake. Timepoint: Before intervention and 12 week after intervention. Method of measurement: 24 hour recall questionnaire. Micronutrients and Macronutrients intake. Timepoint: Before intervention and 12 week after intervention. Method of measurement: 24 hour recall questionnaire. Vice-chancellor for research Iran University of Medical Sciences Approved 2020-12-26 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, The intersection of Sheikh Fazlallah and Shahid Chamran, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)