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IRCT20100209003320N21 IRCT 2021-07-18 Tabriz University of Medical Sciences The effect of propolis supplementation with weight loss diet in treatment of non-alcoholic fatty liver NAFLD The effect of propolis and placebo supplementation with weight loss diet on metabolic status, meta-inflammation, nutritional status and liver function in patients with non-alcoholic fatty liver 2021-07-23 anticipated 46 Complete https://irct.ir/trial/56177 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: ‏In this study, block randomization will be used to create a balance in the number of samples allocated to each of the study groups (supplement and placebo). All blocks will be the same size, and in this two-group experiment, there will be 6 blocks (including 3 participants in the supplement group and 3 participants in the placebo group). Randomization tool, RAS (Random allocation software) is version 2.0 that these random software in addition to simple randomization is also able to block randomization. Thus, 46 eligible patients will be blocked based on age, sex and BMI and will be randomly allocated to the supplement group (propolis) or placebo (cornstarch). Allocation concealment is also used for hiding so that the allocated group is not known before the individual is allocated, Blinding description: The person in charge of packaging propolis and placebo supplements without knowing the content will determine the type of supplement or placebo that has no role in the implementation and analysis of the study data. None of the researchers or patients will be aware of the type of combination each person is receiving. 2-3 non-alcoholic fatty liver. Intervention 1: Intervention group: Supplement group (propolis three capsules of 500 mg per day after each meal) for 8 weeks from Shahdineh Company of Isfahan with weight loss diet.The amount of calories for each person will be calculated based on the Mifflin formula and 500 kcal will be deducted from it in order to lose weight. The distribution of macronutrients will be 50% carbohydrates, 20% protein and 30% fat. Intervention 2: Control group: placebo (three capsules of 500 mg of corn starch per day after each meal) for 8 weeks from Shahdineh Company of Isfahan with weight loss diet.The amount of calories for each person will be calculated based on the Mifflin formula and 500 kcal will be deducted from it in order to lose weight. The distribution of macronutrients will be 50% carbohydrates, 20% protein and 30% fat. 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.Mahlagha, Nikbaf, E-mail address:mahlaghanikbaf@gmail.com , cellphone number: 00989155122119 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) Both sexes Age 20-50 years Body mass index (BMI) in the range of 30-40 Kg/m2 Willingness to participate in the study Non-alcoholic fatty liver disease (NAFLD) (grades 1 and 2) 20 years 50 years Both pregnancy, lactation and menopause in women Skin or gastrointestinal allergies to propolis, honey and any bee products Smoking or alcohol use Following a particular diet in the last three months Using synthetic or herbal medicines for weight loss in the last three months Performing weight loss surgery in the past year or strict weight loss diets in the last three months Use antibiotics or supplements affecting liver enzyme levels in the last three months Having symptoms of infectious or inflammatory disease or recent surgery K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Supplement group (propolis three capsules of 500 mg per day after each meal) for 8 weeks from Shahdineh Company of Isfahan with weight loss diet.The amount of calories for each person will be calculated based on the Mifflin formula and 500 kcal will be deducted from it in order to lose weight. The distribution of macronutrients will be 50% carbohydrates, 20% protein and 30% fat. Control group: placebo (three capsules of 500 mg of corn starch per day after each meal) for 8 weeks from Shahdineh Company of Isfahan with weight loss diet.The amount of calories for each person will be calculated based on the Mifflin formula and 500 kcal will be deducted from it in order to lose weight. The distribution of macronutrients will be 50% carbohydrates, 20% protein and 30% fat. Tumor necrosis factor. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: ELISA method. MCP-1. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: ELISA method. Toll-like receptor 4. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: ELISA method. Fasting Blood Sugar. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: Enzymatic method. Insulin. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: ELISA method. Total cholesterol. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: Enzymatic method. Triglyceride. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: Enzymatic method. HDL-C. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: enzymatic colorimetric method using spectrophotometer. HOMA-IR. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: According to the formula. Body mass index. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: According to the formula. Waist circumference. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: Meter. Waist-to-hip ratio (WHR). Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: According to the formula. Waist to Height Ratio (WHtR). Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: According to the formula. Alanine aminotransferase. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: enzymatic method. Aspartate aminotransferase. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: Enzymatic method. Gamma Glutamyl transferase. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: Enzymatic method. Fatty liver grade. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: Ultrasound findings. NAFLD fibrosis score. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: According to the formula. Energy and macronutrients received. Timepoint: At the beginning and 8 weeks after the start of the study. Method of measurement: 3-Day Food Record form. Tabriz University of Medical Sciences Approved 2021-02-16 Ethics committee of Tabriz university of medical sciences Tabriz University of Medical Sciences, Attar Neishabouri Ave, Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)