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IRCT20100209003320N22 IRCT 2021-10-04 Tabriz University of Medical Sciences The effect of myo-inositol supplementation on NAFLD The effect of myo-inositol supplementation on nutritional status, cardiometabolic factors, liver function, oxidative stress, visfatin and hs-CRP levels, gene expression of insulin resistance pathway and HIF1α, NF-kB, TNF-α, Interleukin-1β and 6 in patients with non-alcoholic fatty liver disease. 2021-10-23 anticipated 50 Complete https://irct.ir/trial/57941 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: A research assistant not otherwise involved in the study, will be randomly allocated 50 patients into one of the two experimental groups (1:1), using the Random allocation software (RAS) and randomized block procedure of size 3 (age (18-30 vs 31-50 years)- gender (female vs male) and BMI (<35 kg/m2 vs. ≥35 kg/m2)), Blinding description: The person in charge of packaging myo-inositol 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. 3 non-alcoholic fatty liver. Intervention 1: Intervention group: Patients in this group will receive myo-inositol supplement and nutritional recommendation for 8 weeks. The supplement is: Sachet contains 2 grams of myo-inositol powder dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. Intervention 2: Control group: Patients in this group will receive placebo and nutritional recommendations for 8 weeks. The placebo is: A sachet containing 2 grams of maltodextrin powder which will 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: Ms.Sara َArefhosseini, E-mail address:arefhosseini.sa@gmail.com, cellphone number: 09354720098 and Somaye Rostami E-mail address:somyrostammi96@gmail.com, cellphone number:09142399475 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) Age 18-55 years Body mass index in the range of 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 Infertility treatment, taking oral contraceptive pills Smoking and alcohol use Adherence to a special diet 3 months before the study Use of chemical or herbal medicines for weight loss and use of hepatotoxic drugs such as phenytoin, amoxifine , lithium and antihypertensive drugs and lipid-lowering drugs (statins), insulin sensitiser medications Taking antibiotics or dietary supplements that affect the levels of liver enzymes History of weight loss surgery over the last year or rigid weight loss diets three months before the trial Use of corticosteroids and NSAIDs or any type of supplements for 3 months before or during the study Use of any multivitamin (vitamin E and folic acid, etc.), antioxidants (L-arginine, glutamine) and fish oil supplements for 3 months before or during the study those with cardiovascular disease, hepatic, renal, intestinal, thyroid and parathyroid dysfunction, billiary disease, known autoimmune diseases, PCOs, cancers and conditions with mal-absorption such as Sprue and Crohn Having symptoms of a recent infectious, inflammatory disease or recent surgery Candidate or history of Liver transplant Intention for pregnancy 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. The supplement is: Sachet contains 2 grams of myo-inositol powder dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. Control group: Patients in this group will receive placebo and nutritional recommendations for 8 weeks. The placebo is: A sachet containing 2 grams of maltodextrin powder which will be dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. Insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA method. HbA1C. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Chromatography. Total cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic-colorimetric method using spectrophotometer. Triglyceride. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic-colorimetric method using spectrophotometer. HDL-C. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic-colorimetric method using spectrophotometer. LDL-C. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. HOMA-IR. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. 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. Glutathione peroxidase(GPX). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. Nitric oxide (NO). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. Catalase (CAT). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. Paraoxonase arylesterase - 1 (PON-1). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spectrophotometric method. HIF1α gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Nuclear factor kappa-B (NF-kB) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Tumor necrosis factor alpha (TNF-α) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Interleukin-1-beta gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Interleukin 6 gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Body mass index (BMI). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. Waist circumference. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: measuring tape. Waist-to-hip ratio (WHR). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. Waist to Height Ratio (WHtR). 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. Fat Free 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. Serum albumin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: using BROMOCRESOL GREEN. Platelets count. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using Coulter counter. AMPK gene expression. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). PDK gene expression. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). AKT gene expression. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Visfatin. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: ELISA method. Hs-CRP. Timepoint: Baseline and 8 weeks after the intervention. Method of measurement: ELISA method. Fatty liver grade. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Ultrasonigraphy. NAFLD fibrosis score. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. 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. Tabriz University of Medical Sciences Approved 2021-09-13 Ethic Committee of Tabriz University of Medical Sciences Golgasht St., Attar Neishaboori Ave., Tabriz University of Medical Sciences, School of Nutrition & Food Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)