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IRCT20100209003320N20 IRCT 2021-06-27 Tabriz University of Medical Sciences The effect of propolis supplementation in treatment of non-alcoholic fatty liver NAFLD The effect of propolis and placebo supplements associated with weight loss diet on prooxidant-antioxidant balance, oxidative stress status, nutritional status, liver function and body composition in patients with non-alcoholic fatty liver 2021-07-06 anticipated 46 Complete https://irct.ir/trial/56185 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Individuals in both the placebo and supplement groups will receive a weight loss diet; The amount of calories per person is calculated based on the Mifflin formula and 500 kcal will be deducted from the total calories in order to lose weight. The distribution of macronutrient calories will be 50% carbohydrates, 20% protein and 30% fat, Randomization description: 46 eligible patients will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study, Blinding description: In this study, the main investigators ((including the student and her supervisors and adviser professors as well as the patients) will be blinded to the type of the supplement (propolis or placebo) received by each patient. 3 Non-alcoholic fatty live. Intervention 1: Intervention group: Patients in this group will receive a weight loss diet with propolis supplement (3 capsules of 500 mg per day) after each meal for 8 weeks. This supplement is provided by Shahdineh Company of Isfahan. Intervention 2: Control group: Patients in this group will receive a weight loss diet with placebo supplement (3 500 mg capsules per day of cornstarch) for 8 weeks after each meal. This supplement is provided by Shahdineh Company of Isfahan. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared When: Access starting 12 months after publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers , for conducting meta-analysis Where to obtain: Ms.Hamideh, Nazari bonab, E-mail address:hamideh.nazarii@gmail.com, cellphone number: 00989148616822 How to obtain: The applicant should provide a brief description of the aims and methods of his Meta-analysis . His request will be assessed and , if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days Comments:
public Dr. Mehrangiz Ebrahimimamagani
Golgasht street ,Attar neyshaburi street, nutriton faculty
Tabriz Iran (Islamic Republic of) 5185747731 +98 41 3334 1113 mebrahimimameghani@gmail.com Tabriz University of Medical Sciences scientific Dr. Mehrangiz Ebrahimimamagani
Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
Tabriz Iran (Islamic Republic of) 5185747731 +98 41 3334 1113 mebrahimimameghani@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) NAFLD (Grade 1 and 2) Age 20-50 years Body mass index(BMI) in the range of 30-40 Kg / m2 Willingness to participate in the study 20 years 50 years Both Pregnancy, lactation and menopause in women Smoking and alcohol use Skin or gastrointestinal allergies to propolis, honey and any of the beehive products Adherence to a special diet three months before the study Consumption of chemical or herbal medicines for weight loss Taking antibiotics or various supplements that affect the levels of liver enzymes Performing weight loss surgery in the last year or strict weight loss diets in the last three months Suffering from any conditions affecting liver function Use of hepatotoxic medications Taking multivitamins or antioxidant supplements during the last 3 months K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Patients in this group will receive a weight loss diet with propolis supplement (3 capsules of 500 mg per day) after each meal for 8 weeks. This supplement is provided by Shahdineh Company of Isfahan. Control group: Patients in this group will receive a weight loss diet with placebo supplement (3 500 mg capsules per day of cornstarch) for 8 weeks after each meal. This supplement is provided by Shahdineh Company of Isfahan. Pro-Oxidant Antioxidant Balance (PAB). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic_ colorimetric method and read it through ELISA. Glutathione peroxidase(GPX). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. Superoxide dismutase (SOD). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. Malondialdehyde (MDA). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. Total Antioxidant Capacity (TAC). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. Fat mass. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using bioelectric impedance analyzer. Free fat mass. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using bioelectric impedance analyzer. Body water. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using bioelectric impedance analyzer. Intake of energy, macronutrients and antioxidant micronutrients. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: The intake by 3-days food record form and analysis using nutritionist 4 software. Alanine aminotransferase. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method. Aspartate aminotransferase. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method. Gamma Glutamyl transferase. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method. Fatty liver grade. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Ultrasound findings. Liver fibrosis score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Liver fibrosis score formula. Tabriz University of Medical Sciences Approved 2021-01-11 Ethics committee of Tabriz university of medical sciences Attar Nishapuri Street , Faculty of Nutrition and Food Science tabriz East Azarbaijan Iran (Islamic Republic of)