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IRCT20091114002709N58 IRCT 2022-01-11 Iran University of Medical Sciences effect of pomegranate peel extract on non-alcoholic fatty liver disease The effect of supplementation with pomegranate peel extract on liver enzymes, hs-CRP and lipid profile in patients with non-alcoholic fatty liver disease: a randomized, double-blind clinial trial. 2021-11-06 anticipated 46 Complete https://irct.ir/trial/58875 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: By random allocation participants will divide into intervention and placebo groups each of which consist of 23 patients. Since The results of biochemical tests varies in age range from 30 to 60 and it can affect the result of the intervention and to make sure about the equal distribution of variables among groups, randomization is done in a randomized, stratified method based on the age. A randomized list is produced and randomization will be done based on the age by relevant list, Blinding description: pomegranate extract capsules and placebo capsules are similar in appearance, weight and packaging. individual codes will be used on the packaging. 3 Nonalcoholic fatty liver disease. Intervention 1: Intervention group: consumption of two capsules per day (each of them containing 500mg extract of pomegranate peel ) for 12 weeks. Intervention 2: Control group: consumption of two placebo capsules for 10 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Farzad Shidfar
School of Health, Iran University of Medical Science, Shahid Hemmat highway.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad Shidfar
School of Health, Iran University of Medical Science, Shahid Hemmat highway.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Alanine aminotransferase (ALT) greater than 20 IU/L for women and greater than 30 IU/L for men. Evidence of fatty liver in ultrasonography with a score of 1 or 2. Being volunteer or Wishing to attend. age: 30 to 60 years. BMI: 25Kg/m2 to 35Kg/m2. 30 years 60 years Both Other acute or chronic hepatic disorders cardiovascular disease, renal disease, infectious disease, diabetes, cancer. hemorrhoid or chronic constipation. intensive weight loss or weight gain during 3 months prior to intervention. Any use of antioxidant supplements during 1 month prior to intervention. Use of hepatotoxic medications during last month. Use of lipid lowering medications or insulin-sensitizing medications. Problem in blood coagulation. Dysmenorrhea or excessive bleeding during menses. History of benign tumours. Consumption of alcohol, addictive drugs and smoking. The patient's unwillingness to continue cooperation. pregnancy. lactation. K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: consumption of two capsules per day (each of them containing 500mg extract of pomegranate peel ) for 12 weeks Control group: consumption of two placebo capsules for 10 weeks Alanine aminotransferase (ALT). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. Aspartate aminotransferase (AST). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. High density lipoprotein cholesterol (HDL-C). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. Low density lipoprotein cholesterol (LDL-C). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. Alkaline phosphatase (ALP). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. Total cholesterol (TC). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. Triglyceride (TG). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. High sensitive reactive protein (hs-CRP). Timepoint: At the beginning and at the end of week 10. Method of measurement: Laboratory kit. Iran University of Medical Sciences Approved 2021-11-21 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway. Tehran Tehran Iran (Islamic Republic of)