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IRCT20120415009472N19 IRCT 2019-10-14 Vice-chancellor for research Iran University of Medical Sciences Effects of Rosemary (Rosmarinus officinalis) Leaves Powder And Weight Reducing Diet on Hs-CRP, MDA, TAC, Blood Pressure, Anthropometric measurement, Quality of life, Sleep and Appetite in Patients with Non-Alcoholic Fatty Liver Disease Effects of Rosemary (Rosmarinus officinalis) Leaves Powder And Weight Reducing Diet on Hs-CRP, MDA, TAC, Blood Pressure, Anthropometric measurement, Quality of life, Sleep and Appetite in Patients with Non-Alcoholic Fatty Liver Disease 2019-09-23 anticipated 120 Complete https://irct.ir/trial/36981 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, patients referred to the Gastroenterology and Liver Clinic of Razi Hospital in Rasht will be selected by available sampling method. For randomization, the permuted block randomization will be used with 4 blocks. According to the sample size of 120, 30 blocks of 4 will be produced using the online site (www.sealedenvelope.com), Blinding description: In order to apply concealment in the randomization process, unique code 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 patients, as well as the researcher, will be aware of the group in which the patients will be placed and the type of intervention (rosemary or placebo). 2 Nonalcoholic fatty liver disease. Intervention 1: Intervention group (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 low-calorie diet will be calculated as 500 kcal less than the energy needed by each patient, and the macronutrient division is calculated as 30% fat, 15% protein and 55% carbohydrate. The diet will be adjusted according to the amount of units needed for each individual diet and a list of food substitutes will be explained. Physical activity is also recommended to all patients for at least 3 days a week. Diet adherence and physical activity will be assessed weekly through telephone interviews as well as using dietary intake records and 24-hour physical activity at the beginning and end of the study (35). The intervention group also received 4 grams of rosemary leaf powder daily. Intervention 2: Control group (n = 60): Low-calorie diet and physical activity similar to the intervention group with 4 grams of starch powder (placebo) daily. 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 Evidence of hepatic steatosis in liver ultrasonography (grade 1 to 3 fatty liver) Increased liver enzymes than normal (AST> 38 and ALT> 40 for men and AST> 31 and ALT> 33 for women) BMI in the range of 25-40 kg / m2 aged between 20 and 65 years 20 years 65 years Both Unwillingness to participate in the study Secondary conditions that lead to hepatic steatosis, including: alcohol consumption, hereditary disorders affecting liver status (hemochromatosis and Wilson's disease), and known autoimmune disease Other 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 (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 low-calorie diet will be calculated as 500 kcal less than the energy needed by each patient, and the macronutrient division is calculated as 30% fat, 15% protein and 55% carbohydrate. The diet will be adjusted according to the amount of units needed for each individual diet and a list of food substitutes will be explained. Physical activity is also recommended to all patients for at least 3 days a week. Diet adherence and physical activity will be assessed weekly through telephone interviews as well as using dietary intake records and 24-hour physical activity at the beginning and end of the study (35). The intervention group also received 4 grams of rosemary leaf powder daily. Control group (n = 60): Low-calorie diet and physical activity similar to the intervention group with 4 grams of starch powder (placebo) daily. Malondialdehyde. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Colorimetric method. Total Antioxidant Capacity. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Colorimetric method. High sensitivity C-reactive protein. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: Turbidometric method. Systolic blood pressure. Timepoint: Before intervention and 8 weak after intervention. Method of measurement: Mercury barometric. Diastolic blood pressure. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Mercury barometric. Weight. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Scales. Waist. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Meter. Hip circumference. Timepoint: Before intervention and 8 months after intervention. Method of measurement: Meter. Waist to hip ratio. Timepoint: Before intervention and 8 months after intervention. Method of measurement: calculation. Body fat percentage. Timepoint: Before intervention and 8 months after intervention. Method of measurement: inbody. BMI. Timepoint: Before intervention and 8 months after intervention. Method of measurement: calculation. Quality of Life. Timepoint: Before intervention and 8 months after intervention. Method of measurement: SF-36 questionnaire. Sleep quality. Timepoint: Before intervention and 8 months after intervention. Method of measurement: The Pittsburgh Sleep Quality questionnaire. Appetite. Timepoint: Before intervention and 8 months after intervention. Method of measurement: CNAQ questionnaire. Vice-chancellor for research Iran University of Medical Sciences Approved 2019-08-31 Ethics Committee of Iran University of Medical Sciences Sheikh Fazlollah and Chamran Intersection, Hemmat Highway, Iran University of Medical Sciences,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)