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IRCT20210530051441N2 IRCT 2022-03-12 Qazvin University of Medical Sciences The effect of myo-inositol supplementation on NAFLD The effect of myoinositol supplementation on serum levels of Pro-oxidant Antioxidant Balance (PAB), leptin and adiponectin, nutritional status and appetite in patients with non-alcoholic fatty liver disease 2022-03-11 anticipated 42 Complete https://irct.ir/trial/60549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients in both placebo and supplement groups will receive nutritional recommendations, Randomization description: In this study, random allocation will be performed using the r.allocation command in Stata/MP 17.0*64 software, which performs both stratification and blocking at the same time. Thus, 42 eligible patients will be classified into 8 stratas based on 3 variables: age, sex and BMI (age ("18-35" vs "36-50"), gender ("female" vs "male"), BMI ("30-35 Kg/m2" vs "35-40 Kg/m2")) and we will define these 8 stratas in the r.allocation command. Also, since we will have 2 intervention and placebo groups, we will define blocks with size 2, which will be generated automatically by the Stata software at the same time, and we will use the generated sequence for random allocation, Blinding description: The person who packaged supplements/placebo will not be aware about the content and also has no role in the implementation and analysis of the data. None of the researchers or patients will be aware of the type of combination each person is receiving. 3 Non-alcoholic fatty liver. Intervention 1: Intervention group: Patients in this group will receive myo-inositol supplement and nutritional recommendation for 8 weeks. Two 2 gr sachet of myo-inositol powder will be asked to be dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. As there is no specific recommendation for NAFLD we use the American Diabetes Association that recommends consuming more fruits, vegetables, whole grains and less saturated fatty acids. Intervention 2: Placebo group: Patients in this group will receive placebo and nutritional recommendations for 8 weeks. Two 2 gr sachet of maltodextrin powder which will be asked to be dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. 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: Mrs.Zahra alizadeh zonouzi, Email address: z.alizadeh76@yahoo.com, cellphone number: 09388202522 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 Mohammad Reza Shiri Shahsavar
قزوین بلوار باهنر دانشگاه علوم پزشکی
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3336 9581 nutshiri@gmail.com Qazvin University of Medical Sciences scientific Mohammad Reza Shiri Shahsavar
Qazvin university of medical sciences, Bahonar blv
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3336 9581 nutshiri@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Age 18-55 years Body mass index = 30-40 Kg /m2 Willingness to cooperate Hepatic steatosis based on Grade 1 and 2 NAFLD disease 18 years 55 years Both Athlete, pregnancy, lactation and menopause in women Smoking and drinking alcohol Adherence to a special diet or weight loss 3 months before the study Use of chemical or herbal medicines for weight loss, hepatotoxic (phenytoin, amoxifine, lithium), lipid-lowering (statins), Insulin sensitizer, corticosteroids and non-steroidal, anti-inflammatory medications and any dietary supplements for 3 months before the study History of weight loss surgery over the last year those with cardiovascular, hepatic, renal, intestinal, thyroid and parathyroid dysfunction, billiary, any known autoimmune diseases, PCOs, cancers and conditions with mal-absorption such as Sprue and Crohn Candidate or history of Liver transplant K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Patients in this group will receive myo-inositol supplement and nutritional recommendation for 8 weeks. Two 2 gr sachet of myo-inositol powder will be asked to be dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. As there is no specific recommendation for NAFLD we use the American Diabetes Association that recommends consuming more fruits, vegetables, whole grains and less saturated fatty acids. Placebo group: Patients in this group will receive placebo and nutritional recommendations for 8 weeks. Two 2 gr sachet of maltodextrin powder which will be asked to be dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. Serum leptin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA method. Serum adiponectin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA method. Ratio of leptin to adiponectin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. Pro-oxidant Antioxidant Balance (PAB). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic and chemical methods. Body mass index (BMI). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. Fat mass. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using bioelectric impedance analyzer. Energy, macronutrients and micronutrients intakes. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: a 3-days 24 hour- recall questionnaire at each phase will be completed and analyzed using Nutritionist 4 software. Physical activity level. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Via short form of IPAQ questionnaire. Appetite status. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Validated appetite questionnaire. Weight. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: using Seca scale. Fat Free mass. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using body analyzer based on bioelectric impedance. Fatty liver grade. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Ultrasonigraphy. Alanine aminotransferase (ALT). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic method. Aspartate aminotransferase (AST). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic method. Qazvin university of medical sciences Approved 2021-11-30 Qazvin university of medical science Qazvin university of medical sciences, bahanor blv. Qazvin Qazvin Iran (Islamic Republic of)