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IRCT20190724044322N2 IRCT 2022-04-18 Tabriz University of Medical Sciences The effect of myo-inositol supplementation on NAFLD The effect of myo-inositol supplementation and placebo on the expression level of SIRT-1 pathway genes (SIRT-1, eNOS, NF-kB, LDLR, LOX-1, LXRα, ABCA1 and PCSK9) involved in atherosclerosis in peripheral blood mononuclear cells of patients with non-alcoholic fatty liver disease 2022-05-10 anticipated 44 Complete https://irct.ir/trial/60550 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 44 patients into one of the two experimental groups (1:1), using the Random allocation software (RAS) and randomized block for age, gender and BMI, 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 oral myo-inositol (a water soluble six carbon alcoholic sugar) supplement and nutritional recommendation (at the beginning and during the study) 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.Individuals are also asked to return unused sachets at the end of each two weeks to determine compliance and measure weight. 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.Individuals are also asked to return unused sachets at the end of each two weeks to determine compliance and measure weight. 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: neda roshanravan neda.roshanravan10@gmail.com +98 914 371 0080 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 Neda Roshanravan
Shahid Madani Heart Hospital; in front of the University Research and Development Complex; Daneshgah street
Tabriz Iran (Islamic Republic of) 5166615573 +98 41 3337 3958 neda.roshanravan10@gmail.com Tabriz University of Medical Sciences scientific Neda Roshanravan
Shahid Madani Heart Hospital; Daneshgah street; in front of University Research and Development Complex; Tabriz; Iran
Tabriz Iran (Islamic Republic of) 5166615573 +98 41 3335 7767 neda.roshanravan10@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 insulin sensitizer medications, antibiotics or any kind of supplements that may affect liver enzymes History of weight loss surgery over the last year or rigid weight loss diets three months before the trial Use of NSAIDs or any any multivitamin or 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 use of any antihypertensive drugs and lipid-lowering drugs (statins) and medications related to cardiovascular patients 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 oral myo-inositol (a water soluble six carbon alcoholic sugar) supplement and nutritional recommendation (at the beginning and during the study) 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.Individuals are also asked to return unused sachets at the end of each two weeks to determine compliance and measure weight. 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.Individuals are also asked to return unused sachets at the end of each two weeks to determine compliance and measure weight. Sirtuin-1 (SIRT-1) 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). Endothelial nitric oxide synthase (eNOS) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Low density lipoprotein receptor (LDLR) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Lectin-type oxidized LDL receptor 1 (LOX-1) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Liver X receptor alpha (LXR-alpha) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). ATP Binding Cassette Subfamily A Member 1(ABCA1) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR). Weight. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: using Seca scale. Body mass index (BMI). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula. Fatty liver grade. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Ultrasonigraphy. 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. Tabriz University of Medical Sciences Approved 2022-02-02 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)