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IRCT20150205020965N5 IRCT 2019-12-13 Tabriz University of Medical Sciences The effect of camelina oil in patients with nonalcoholic fatty liver Comparison of the effects of Camelina and Sunflower oils on metabolic, inflammatory and anti-inflammatory factors in patients with Non-alcoholic fatty liver 2019-11-20 anticipated 46 Complete https://irct.ir/trial/43187 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Classification of these variables will be used to match them in BMI, age and sex. All of the 23 patients will be randomly divided into two groups including intervention (Weight loss diet+ Camelina oil ) and control (Weight loss diet + Sunflower oil) by using RAS software which is dividing patients to 2 and 4 blocks, 1 and 2 codes will be given them respectively too, Blinding description: After randomizing, the same weight loss diets with similar recommendations will be given by a dietitian to both groups.Both oils will be packaged in similar 900 grams opaque containers, without the researcher intervention and will be coding (1 and 2). The dietitian will introduce the oils by codes to patients.Until the reporting the results patient, researcher and analyser will not be aware of the codes. After the end of research, decodation will be done. So the study will be Triple-Blind. 3 Non-alcoholic fatty liver. Intervention 1: In this study, Camelina oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Camelina oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention. Intervention 2: In this study, Sunflower oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Sunflower oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention. Yes - There is a plan to make this available What will be shared: Reporting the results When: After finishing and publishing the project articles To whom: Academic researchers Conditions: With the permission of the project researcher and the project sponsoring organization - University of Nutrition Research and Research Deputy Where to obtain: Dr. Parvin Dehghan, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences Email:Dehghan.nut@gmail.com +98 914 471 0299 How to obtain: The applicator can send a request to the person responsible for the study by email. Comments:
public Parvin Dehghan
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 33340634 dehghan.nut@gmail.com Tabriz University of Medical Sciences scientific Parvin dehghan
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665931 +98 914 471 0299 Dehghan.nut@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age range 20 to 65 years BMI≥25 No weight changes over the past 3 months Restricted Consumption of edible nuts and fish Tendency to use camelina oil Having grade 1 and 2 of non-alcoholic fatty liver disease 20 years 65 years Both Having other liver disease apart from NAFLD (alcoholic fatty liver, viral hepatitis, cirrhosis and biliary obstruction, liver cancer)) Liver transplantation Pregnancy and Lactation Kidney, Cardiovascular Disease Alcohol and tobacco consumption high physical activity having acute illness Use of drugs such as glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDS), hepatotoxic drugs, antibiotics Use antioxidant supplements and W3 history of using weight loss diet or a special diet over the past 6 months k76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo In this study, Camelina oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Camelina oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention. In this study, Sunflower oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Sunflower oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention. ALT. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer. AST. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer. ALP. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer. Degree of hepatic steatosis. Timepoint: At baseline and three months after baseline. Method of measurement: Ultrasound. Fasting glucose. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer. Insulin Sensitivity Index (QUICK). Timepoint: At baseline and three months after baseline. Method of measurement: Computing. Insulin Resistance Index (HOMA-IR). Timepoint: At baseline and three months after baseline. Method of measurement: Computing. Fasting insulin. Timepoint: At baseline and three months after baseline. Method of measurement: Chemoluminescense. Total cholestrol. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer. HDL-cholesterol. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer. LDL-cholesterol. Timepoint: At baseline and three months after baseline. Method of measurement: calculation of LDL using friedewald equation. Triglyceride. Timepoint: At baseline and three months after baseline. Method of measurement: Hitachi 911 auto-analyzer. Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Dedicated Kit. Tumor Necrosis Factor(TNF). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Dedicated Kit. Interleukin 10(IL10 ). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Dedicated Kit. Total antioxidant capacity. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Malondialdehyde. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Superoxide dismutase. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Glutathione peroxidase. Timepoint: At baseline and three months after baseline. Method of measurement: kit. 8-iso-prostaglandin F2α (8-iso-PGF2α). Timepoint: At baseline and three months after baseline. Method of measurement: kit. Leptin. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Adiponectin. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Ghrelin. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Appetite status. Timepoint: At baseline and three months after baseline. Method of measurement: questionnaire. PPAR-α expression. Timepoint: At baseline and three months after baseline. Method of measurement: pcr. Mental health. Timepoint: At baseline and three months after baseline. Method of measurement: questionnaires. Lipopolysaccharide. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Cd4. Timepoint: At baseline and three months after baseline. Method of measurement: kit. IL17. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Cd8. Timepoint: At baseline and three months after baseline. Method of measurement: kit. ILB1. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Brain-derived Neurotrophic Factor. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Body Mass Index (BMI). Timepoint: At baseline and three months after baseline. Method of measurement: Scale-Meter. Amount of received energy. Timepoint: At baseline and three months after baseline. Method of measurement: questionnaire. Daily macronutrient intake (carbohydrate, protein, fat). Timepoint: At baseline and three months after baseline. Method of measurement: questionnaire. Waist circumference (WHR). Timepoint: At baseline and three months after baseline. Method of measurement: Calculate by splitting waist to hip. Blood pressure. Timepoint: At baseline and three months after baseline. Method of measurement: Mercuric barometr. Assessment of the body composition. Timepoint: At baseline and three months after baseline. Method of measurement: BIA devices. Tabriz University of Medical Sciences Approved 2019-10-20 Ethics Committee of Tabriz University of Medical Sciences Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)