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IRCT20210201050210N1 IRCT 2021-04-19 Tehran University of Medical Sciences Effect of daily consumption of probiotic yogurt in patients with non-alcoholic fatty liver Effect of daily consumption of probiotic yogurt on liver enzymes steatosis and fibrosis in patients with nonalcoholic fatty liver disease 2021-12-06 anticipated 68 Complete https://irct.ir/trial/54112 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals will be classified based on age(20-40/40-60), gender (male/female) and BMI (25-30/30-35) into different blocks. To do randomization, an identification code will be given to each participant, and then the codes of each two participants with the same age, gender and BMI will be poured into the lottery container. Random allocation will be done by a person who is unaware of the study. The first code will be assigned to the intervention group, the second code to the control group and so other participants will be randomly assigned to the two groups, Blinding description: The shape, appearance, packaging, color and smell of both probiotic and non-probiotic yogurts will be quite similar. In addition, the person who provides yogurts to patients is aware of the type of yogurt, but the researcher and the patient are not aware of it. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group: They will receive 300g of probiotic yogurt enriched with Bifidobacterium lactis and Lactobacillus acidophilus strains daily for 12 weeks. Microbiological analyzes showed that the average colony content of both strains is 10 ^ 6 CFU / g. Intervention 2: Control group: Control group: 300g will receive conventional yogurt for 12 weeks. 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 There is no more information.
public Sara Ebrahimi-Mousavi
No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5975 Sara.mse95@gmail.com Tehran University of Medical Sciences scientific Sara Ebrahimi-Mousavi
No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5975 sara.mse95@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Non-alcoholic fatty liver disease was approved by a gastroenterologist using fibroscan examination Individuals aged 20 to 60 years Patients have a fixed plan for medication use during the last 3 months Body mass index between 25 to 35 kg/m 2 20 years 60 years Both Smokers History of alcohol consumption Adherence to a special diet in the last 3 months Pregnant or lactating women or those planning to get pregnant in the next three months Menopausal women Individuals with pathologic conditions affecting the liver, including acute and chronic hepatitis, viral hepatitis, liver transplantation, autonomic hepatitis, hemochromatosis, primary biliary cirrhosis, Wilson's disease, antitrypsin deficiency and thyroid disease People with lactose intolerance People taking antibiotics patients taking medications affecting serum lipids Individuals taking multivitamin-minerals during the previous month Patients who have used any type of probiotic product in the last two months K76.0 Fatty (change of) liver, not elsewhere classified Rehabilitation Placebo Intervention group: They will receive 300g of probiotic yogurt enriched with Bifidobacterium lactis and Lactobacillus acidophilus strains daily for 12 weeks. Microbiological analyzes showed that the average colony content of both strains is 10 ^ 6 CFU / g. Control group: Control group: 300g will receive conventional yogurt for 12 weeks Hepatic steatosis. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Fibro-scan. Hepatic fibrosis. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Fibro-scan. Liver enzyme (ALT, AST and GGT). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Blood sample. Lipid profile (TG, Total cholesterol, LDL-c and LDH-c). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Blood sample. Glycemic index (FBS, FBI, HOMA-IR and QUICKI). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Blood sample. Weight. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Scales. Waist circumference. Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Tape meter. Body mass index (BMI). Timepoint: Beginning the intervention and 12 weeks later at the end of the intervention. Method of measurement: Formula (weight (kilograms) divided by the squared height (meters)). Tehran University of Medical Sciences Approved 2021-01-20 Ethics Committee of Tehran University of Medical Sciences First Floor, Faculty of Medicine, Building No. 1, North Door of the University, POURSINA St, GHODS St, ENGHELAB St Tehran Tehran Iran (Islamic Republic of)