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IRCT20150205020965N4 IRCT 2019-12-13 Tabriz University of Medical Sciences The effect of Camelina oil with and without Resistant dextrin supplementation on Non-alcoholic fatty liver The effect of Camelina oil with and without Resistant dextrin supplementation on metabolic, inflammatory and anti-inflammatory markers in patients with Non-alcoholic fatty liver 2019-11-15 anticipated 32 Complete https://irct.ir/trial/43183 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At baseline, eligible individuals will be matched for BMI, age, and sex according to the classification of these variables. Individuals will be randomly divided into two groups of 16 intervention (receiving weight loss diet + Camelina oil +Maltodextrin) control (recipient). Weight loss regimen + Camelina oil + Resistant dextrin) divided into 2 and 4 blocks using RAS software and will be given codes 1 and 2, Blinding description: After randomization, both groups will be fed the camilina oil with identical weight loss regimens with similar recommendations by the expert. Resistant dextrin and maltodextrin will also be encoded in sachets weighing 5 g in similar packages (metallized) by the researcher and coded with codes 1 and 2. Nutritionists will introduce code to patients when giving diet and oil, resistant dextrin and malt dextrin. Until the patient study results are released, the researcher and data analyzer will not be aware of the assigned codes. So the study will be three-blind. 3 Non-alcoholic fatty liver. Intervention 1: In this study, Camelina oil will be replaced with 15% of the daily total fat intake and patients will receive two of 5-mg dextrin-resistant doses every day 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) ,prebiotic and probiotic sources 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. At the same time, patients will be advised to dissolve one serving of powdered sachets (resistant dextrin) in the lukewarm water each time and consume it by food in the morning and night. The oils and powder supplements 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, supplement intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil and sachet bottles each month to receive the new oil and sachet 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, Camelina oil will be replaced with 15% of the daily total fat intake and patients will receive two of 5-mg maltodextrin doses every day 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) ,prebiotic and probiotic sources 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. At the same time, patients will be advised to dissolve one serving of powdered sachets (maltodextrin) in the lukewarm water each time and consume it by food in the morning and night. The oils and powder supplements 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, supplement intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil and sachet bottles each month to receive the new oil and sachet 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 the study and publishing the project articles To whom: Academic researchers Conditions: with permission of Project Researcher and Project Sponsor - Nutrition Research Center Where to obtain: Dr Parvin Dehghan, Faculty of Nutrition and Food science, Tabriz University of Medical Sciences Email: Dehghan.nut@gmail.com Phone: +98 914 471 0299 How to obtain: The applicant can send an application to the responsible person 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 41333340634 dehghan.nut@gmail.com Tabriz University of Medical Sciences scientific Parvin Dehghan
Faculty of Nutrition and Nutrition, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665931 +98 41333340634 Dehghan.nut@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age range 20 to 65 years BMI≥25 Edible nuts and fish consumption restriction Tendency to use camelina oil and prebiotic Having grade 1 and 2 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, Lactation Having kidney, Cardiovascular Disease Alcohol Consumption and smoking High physical activity Having acute illness Use of drugs such as glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDS), hepatotoxic drugs, antibiotics Taking antioxidant supplements and W3 history of losing weight over the past 6 months or a special diet Unwillingness to use prebiotics Gastrointestinal symptoms incidence during the study Weight changes over the past 3 months K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo In this study, Camelina oil will be replaced with 15% of the daily total fat intake and patients will receive two of 5-mg dextrin-resistant doses every day 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) ,prebiotic and probiotic sources 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. At the same time, patients will be advised to dissolve one serving of powdered sachets (resistant dextrin) in the lukewarm water each time and consume it by food in the morning and night. The oils and powder supplements 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, supplement intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil and sachet bottles each month to receive the new oil and sachet 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, Camelina oil will be replaced with 15% of the daily total fat intake and patients will receive two of 5-mg maltodextrin doses every day 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) ,prebiotic and probiotic sources 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. At the same time, patients will be advised to dissolve one serving of powdered sachets (maltodextrin) in the lukewarm water each time and consume it by food in the morning and night. The oils and powder supplements 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, supplement intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil and sachet bottles each month to receive the new oil and sachet 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: sonography. 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: calculation. Insulin Resistance Index (HOMA-IR). Timepoint: At baseline and three months after baseline. Method of measurement: calculation. Fasting insulin. Timepoint: At baseline and three months after baseline. Method of measurement: kit. Total -cholesterol. 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. Triglyceride. Timepoint: At baseline and three months after baseline. Method of measurement: Autoanalyzer - Hitachi 911. Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and three months after baseline. Method of measurement: Kit. Tumor Necrosis Factor (TNF). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA Kit. Interleukin 10(IL10 ). Timepoint: At baseline and three months after baseline. Method of measurement: ELISA 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. 8-iso-prostaglandin F2α (8-iso-PGF2α). 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. 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. PPAR-α expression. Timepoint: At baseline and three months after baseline. Method of measurement: kit. 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. 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. Il17. Timepoint: At baseline and three months after baseline. Method of measurement: kit. PPAR-α expression. Timepoint: At baseline and three months after baseline. Method of measurement: pcr. Body Mass Index (BMI). Timepoint: At baseline and three months after baseline. Method of measurement: Calculation. Amount of received energy. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire. Daily carbohydrate intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire. Daily protein intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire. Daily fat intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire. Daily fiber intake. Timepoint: At baseline and three months after baseline. Method of measurement: Questionnaire. Weight. Timepoint: At baseline and three months after baseline. Method of measurement: Scale. Waist circumference (WC). Timepoint: At baseline and three months after baseline. Method of measurement: Tape. Hip circumference (HC). Timepoint: At baseline and three months after baseline. Method of measurement: Tape. Waist circumference (WHR) ________________________________________. Timepoint: At baseline and three months after baseline. Method of measurement: Calculation. Blood pressure. Timepoint: At baseline and three months after baseline. Method of measurement: Mercury barometer. 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)