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IRCT20120415009472N20 IRCT 2019-11-12 Vice-chancellor for research Iran University of Medical Sciences Effects of Rosemary (Rosmarinus officinalis) Leaves Powder And Weight Reducing Diet on Lipid Profile, Glycemic Status And Liver Enzymes in Patients with Non-Alcoholic Fatty Liver Disease Effects of Rosemary (Rosmarinus officinalis) Leaves Powder And Weight Reducing Diet on Lipid Profile, Glycemic Status And Liver Enzymes in Patients with Non-Alcoholic Fatty Liver Disease 2019-10-02 anticipated 120 Complete https://irct.ir/trial/37196 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 quadrilateral blocks. According to the sample size of 120 subjects, 30 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 the 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. It 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 powder) 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 Nonalcoholic fatty liver disease. Intervention 1: Intervention group A (n = 60): Low-calorie diet and physical activity design based on the Adult Overweight and Obesity Control Guide (published by the US National Heart, Lung, and Blood Institute). The energy required for each patient is calculated and the macronutrient division is calculated as 30% fat, 15% protein and 55% carbohydrate. The diet will be adjusted based on the amount of units needed for each individual food group and a list of food substitutes will be explained. Physical activity is also recommended to all patients for at least 150 minutes per week. Adherence to the prescribed diet and physical activity are monitored weekly through telephone interviews as well as using dietary intake records and 24-hour physical activity at the beginning and end of the study (34). The intervention group also received 4 grams of rosemary leaf powder daily. Intervention 2: Control group B (n = 60): Low-calorie diet and physical activity similar to group A receive 4 grams of starch powder (placebo). 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 by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran university of Medical Sciences, Hemat Express way, Tehran Cell phone:+98 21 8670 4743 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 the correspond author. Comments: -
public Dr Nahid Aryaeian
School of health, Iran University of Medical Sciences, the intersection of Sheikh Fazlallah and Chamran, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8877 9118 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences scientific Dr Naheed Aryaeian
School of health, Iran University of Medical Sciences,The intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8877 9118 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Desire to participate in studying and signing consent Diagnosis of non-alcoholic fatty liver according to criteria of the American Gastroenterology Association (33): Evidence of hepatic steatosis in liver ultrasound (grade 1 to 3 fatty liver), ALT and AST increased than normal (AST> 38 and ALT> 40 for men and more than 31 and 33 for women), the absence of conditions or diseases secondary to hepatic steatosis, including: alcohol consumption, hereditary disorders affecting liver status (hemochromatosis and Wilson's disease), Known autoimmune disease, history of hepatotoxic drugs (methotrexate, aminodarone, tamoxifen, nifedipine, corticosteroids, valproate, and medications) The virus) and non-use of anticoagulant drugs such as aspirin. Not getting other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), cirrhosis, celiac disease, diabetes, thyroid disorders, cardiovascular, kidney, pulmonary and inflammatory diseases (rheumatism) BMI in the range of 40-25 Kg / m2 The age range is 20 to 65 years No use of any nutritional supplements in the past two months No use of weight-effective drugs over the past two months Not having a weight loss diet (a decrease of more than 10% of the weight) over the past three months Do not use drugs and cigarettes No pregnancy or lactation 20 years 65 years Both Secondary conditions that lead to hepatic steatosis, including: alcohol consumption, hereditary disorders affecting liver status (hemochromatosis and Wilson's disease), and known autoimmune diseaseOther chronic and acute liver diseases and disorders such as hepatitis, cirrhosis, celiac disease, diabetes, thyroid disorders, cardiovascular, renal, pulmonary and inflammatory diseases (rheumatism)History of taking hepatotoxic drugs (methotrexate, amiodarone, tamoxifen, nifedipine, corticosteroids, valproate and antiviral drugs) as well as anticoagulants such as aspirin Use of any nutritional supplement in the past two months Use of weight-loss drugs over the past two months Having a severe weight loss diet (more than 10% weight loss) over the past three months smoking Pregnancy or lactation K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group A (n = 60): Low-calorie diet and physical activity design based on the Adult Overweight and Obesity Control Guide (published by the US National Heart, Lung, and Blood Institute). The energy required for each patient is calculated and the macronutrient division is calculated as 30% fat, 15% protein and 55% carbohydrate. The diet will be adjusted based on the amount of units needed for each individual food group and a list of food substitutes will be explained. Physical activity is also recommended to all patients for at least 150 minutes per week. Adherence to the prescribed diet and physical activity are monitored weekly through telephone interviews as well as using dietary intake records and 24-hour physical activity at the beginning and end of the study (34). The intervention group also received 4 grams of rosemary leaf powder daily. Control group B (n = 60): Low-calorie diet and physical activity similar to group A receive 4 grams of starch powder (placebo). ALT. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Colorimetric method. AST. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Colorimetric method. ALP. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Colorimetric method. GGT. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Colorimetric method. TG. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Enzyme colorimetric method. TC. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Enzyme colorimetric method. HDL-C. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Enzyme colorimetric method. FBS. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Enzymatic calorie meter method. Insulin. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: ELISA. LDL-C. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: calculation. HOMA-Insulin resistance. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: calculation. HOMA- β%. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: calculation. QUICKI. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: calculation. Weight. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Scales. Height. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Meter. Waist. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Meter. BMI. Timepoint: Before intervention and 8 months after intervention. Method of measurement: calculation. Vice-chancellor for research Iran University of Medical Sciences Approved 2019-09-24 Ethics Committee of Iran University of Medical Sciences Shahid Hemmat Highway intersection of Sheikh Fazlollah and Shahid Chamran Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)