non-alcoholic fatty liver. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
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 p
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;HIF1a 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 m | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mehrangiz Ebrahimimamagani
Tabriz University of Medical Sciences
Outcome results
None listed