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IRCT20140208016529N2 IRCT 2018-05-31 Vice Chancellor for Research, Isfahan University of Medical Sciences the effect of lacto ovo vegetarian and normal diets in nonalcoholic fatty liver disease Comparing the therapeutic effects of lacto-Ovo-vegetarian and standard diet on the lipid profile, liver enzymes, and sonographic results of obese and overweight patients with nonalcoholic fatty liver disease: A randomized controlled trial. 2017-12-30 anticipated 80 Complete https://irct.ir/trial/28492 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized controlled clinical trial. Randomization will be conducted through a permuted block randomization with size 2 and Participants will be allocated between groups 1 and 2. Group (1) are the recipients of a calorie restricted Lacto-ovo-vegetarian diet and the group (2) are the recipients of a calorie restricted standard diet. 3 Nonalcoholic Fatty Liver Disease.. Intervention 1: The energy requirements of intervention group are calculated with Mifflin-St Jeor equation on the basis of weight, height, age, and sex of each participant. Take into account the patient’s condition, 200-500 Kcal energy is decreased from the total energy requirements. A 7 days’ dietary plan will be given to each participants including main meals and snakes for 12 consecutive weeks. Dietary plan of the intervention group has been designed based on lacto-ovo-vegetarian diet which refers to the meats elimination (red meats, poultry, fishes, shrimps, …). Intervention 2: The energy requirements of the control group are calculated with the Mifflin-St Jeor equation based on the weight, height, age, and sex of each participant. Take into account the patient’s condition, 200-500 Kcal energy is decreased from the total energy requirements. A 7 days’ dietary plan will be given to each participants including main meals and snakes for 12 consecutive weeks. The dietary plan of the control group considered to be a standard diet which all patients in the will be allowed to consume any foodstuff including all types of meats. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No Information
public Nazila Garousi
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8487 Garousinazila@yahoo.com Esfahan University of Medical Sciences scientific Mohammad hassan entezari
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8487 Entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Over-weight or obese patients with the nonalcoholic fatty liver disease confirmed with imaging techniques increased levels of liver enzymes (serum levels of alanine aminotransferase and aspartate aminotransferase more than 40 U/L); Body Mass Index (BMI) of them is greater than 24.9 and lower than 40 20 years 55 years Both Alcohol consumption Pregnant and lactating women Any known forms of hepatic or metabolic disease except NAFLD, such as hereditary hemochromatosis, Wilson’s disease, cirosis, other metabolic disease history of gastric bypass or intestine surgery Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs; Using nutrition supplements or vegetarian diets Hormone Therapy Patients with a history of hypothyroidism, Cushing’s syndrome renal failure kidney stones. Participants with less than 80% of adherence to the dietary plan are going to be excluded. K75.81 Nonalcoholic steatohepatitis (NASH) Treatment - Other Treatment - Other The energy requirements of intervention group are calculated with Mifflin-St Jeor equation on the basis of weight, height, age, and sex of each participant. Take into account the patient’s condition, 200-500 Kcal energy is decreased from the total energy requirements. A 7 days’ dietary plan will be given to each participants including main meals and snakes for 12 consecutive weeks. Dietary plan of the intervention group has been designed based on lacto-ovo-vegetarian diet which refers to the meats elimination (red meats, poultry, fishes, shrimps, …). The energy requirements of the control group are calculated with the Mifflin-St Jeor equation based on the weight, height, age, and sex of each participant. Take into account the patient’s condition, 200-500 Kcal energy is decreased from the total energy requirements. A 7 days’ dietary plan will be given to each participants including main meals and snakes for 12 consecutive weeks. The dietary plan of the control group considered to be a standard diet which all patients in the will be allowed to consume any foodstuff including all types of meats. Liver enzymes (ALT, AST, ALP). Timepoint: The first day of the study and the last day of 12th week. Method of measurement: Using Microgram/ml - laboratory kit. Lipid profile (TG, LDL, HDL, Total cholestrol). Timepoint: The first day of the study and the last day of 12th week. Method of measurement: laboratory kit. Liver steatosis index. Timepoint: The first day of the study and the last day of 12th week. Method of measurement: Sonography. Waist to hip ratio. Timepoint: The first day of the study and the last day of 12th week. Method of measurement: Non-stretchable tape without any pressure. Body Mass Index (BMI). Timepoint: The first day of the study and the last day of 12th week. Method of measurement: Weight (kilograms) divided by the square of height (meters). Sistolic and diastolic blood pressure. Timepoint: The first day of the study and the last day of 12th week. Method of measurement: By mercury sphygmomanometer. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2017-06-14 Ethic Committee of Isfahan University of Medical Sciences Department of Clinica Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)