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IRCT20210726051988N1 IRCT 2021-09-14 Mashhad University of Medical Sciences Effects of pomegranate peel dry extract supplementation on non-alcoholic fatty liver Effects of pomegranate peel dry extract supplementation on lipid profile, inflammatory and oxidative stress factors and nutritional status in patients with non-alcoholic fatty liver: A randomized clinical trial 2021-10-07 anticipated 54 Complete https://irct.ir/trial/58506 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: stratified randomization by sealed envelops: Randomization of samples to the intervention or control group is done based on blocks classified according to the degree of disease and sex. In this way, for example: man-grade one, woman-grade one, man-grade two, woman-grade two, man-grade three, woman-grade three, with sealed envelopes. An attempt is made to assign an equal number from each class to the intervention and control group, Blinding description: participants, investigator and data collectors, outcome assessors will be blinded. 3 non alcoholic fatty liver- hepatic steatosis and fibrosis- pomegranate peel. Intervention 1: In the intervention group, in addition to lifestyle interventions (diet therapy + physical activity), supplementation of dry extract of pomegranate peel with a dose of 1500 mg is performed for 8 weeks. Each capsule containing 750 mg of dry pomegranate peel extract is given daily with two main meals (breakfast and dinner) for 8 weeks. Intervention 2: In the control group, in addition to lifestyle interventions (diet + physical activity), patients received two capsules containing 750 mg placebo every day for 8 weeks with the same characteristics in terms of shape, smell, color, etc., along with two main meals (breakfast and Dinner) for 8 weeks. Yes - There is a plan to make this available What will be shared: I will inform at the end of the study. When: I will inform at the end of the study. To whom: I will inform at the end of the study. Conditions: I will inform at the end of the study. Where to obtain: I will inform at the end of the study. How to obtain: I will inform at the end of the study. Comments:
public Hanieh Barghchi
Mashhad University of Medical Science,Azadi Square, Mashhad City, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 barghchihn981@mums.ac.ir Mashhad University of Medical Sciences scientific Hanieh Barghchi
Mashhad University of Medical Science,Azadi Square, Mashhad City, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 barghchihn981@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 18-60 years old Detection of hepatic steatosis by two-dimensional elastography device Filling out the informed consent form by the patient 18 years 60 years Both Pregnancy and lactation Morbid obesity (BMI > 40) Alcohol consumption history (more than 20 grams per day for women and more than 30 grams per day for men), Having any type of immunodeficiency disorder, including: autoimmune disorders, cancer, human immunodeficiency virus (HIV) Hepatic or renal insufficiency, other liver diseases such as hepatitis, alcoholic fatty liver consumption of hepatotoxic drugs such as sodium valproate History of food allergy to pomegranate and herbal supplements History of bariatric surgery K76.0 Fatty (Chang of) liver, not elsewhere classified, Nonalcoholic fatty liver disease Treatment - Drugs Placebo In the intervention group, in addition to lifestyle interventions (diet therapy + physical activity), supplementation of dry extract of pomegranate peel with a dose of 1500 mg is performed for 8 weeks. Each capsule containing 750 mg of dry pomegranate peel extract is given daily with two main meals (breakfast and dinner) for 8 weeks. In the control group, in addition to lifestyle interventions (diet + physical activity), patients received two capsules containing 750 mg placebo every day for 8 weeks with the same characteristics in terms of shape, smell, color, etc., along with two main meals (breakfast and Dinner) for 8 weeks. Hepatic steatosis and fibrosis. Timepoint: before and at the end of the study. Method of measurement: Two-dimensional elastography device. Measurement of anthropometric indices (height, weight, body mass index). Timepoint: Before, in the middle and at the end of the study. Method of measurement: Scales with an accuracy of 100 grams, meters,. Measurement of body composition (percentage of adipose and lean tissue) by BIA device. Timepoint: Before, in the middle and at the end of the study. Method of measurement: BIA. Measurement of serum concentrations of oxidative stress indicators including malondialdehyde, superoxide dismutase, glutathione peroxidase,. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Evaluation of IPAQ physical activity questionnaire and three-day food recall. Timepoint: Before, in the middle and at the end of the study. Method of measurement: statistical methods. Measurement of serum concentrations of lipid profiles including TC, HDL-C, LDL-C and TG,. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Measurement of serum concentrations of fasting blood glucose and insulin,. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Measurement of serum concentrations of hepatic profiles including ALT, ALP and AST,. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Measurement of serum concentrations of inflammatory markers including interleukin 6 and reactive protein C. Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Mashhad University of Medical Sciences Approved 2021-08-28 Ethics committee of Mashhad university of medical science Nutrition department, Faculty of medicine Mashhad University of Medical Sciences (MUMS), Azadi square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)