non alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Saffron powder group: One day, one tablet will contain 100 mg of saffron for 3 months (12 weeks). Intervention 2: Placebo group: For a period of 3 months (12 weeks), one tablet will co
Treatment - Drugs
Placebo group: For a period of 3 months (12 weeks), one tablet will contain 100 mg dextrose malto.
Sponsors
Deputy of Research of Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1- Age 18 to 65 years 2. Both sexes 3. Detection of non-alcoholic fatty liver by an expert physician based on the high levels of ALT, AST enzymes >=30U / L in men and> 19U/L in women) and liver transcription 4. Desire to participate in studying and signing conscientious intention Non-inclusion criteria: (exclusion criteria) 1- Pregnancy and lactation or planning pregnancy 2- Use an antioxidant supplement or any nutritional supplement within one month before sampling 3. Acute heart disease, kidney, thyroid, diabetes, infections, hepatitis B and C and other liver diseases (diagnosed by a specialist) and diseases that affect the weight (hyperprolactinemia, Cushing's syndrome) 4. Have a high-gain or weight loss regimen within 3 months prior to sampling 5- Using effective drugs on weight, fatty liver and insulin resistance during 3 months before sampling (hormonal, antidepressant, anti-psychotics) 6- Use of drugs that are probably related to NAFLD: 7- (valporic acid, tetracycline, systematic glucocorticoid, methotrexate amidarone, anabolic steroids, estrogen, tamoxifen or other known hepatotoxic drugs) Exit criteria: 1. Unwillingness to continue cooperation in research 2- Initiating the use of anti-NASH drugs (thiazolidindiones, vitamin E, betaine, milk thistle, UDCA, SAM-E, gemfibrozil, probiotic, anti-TNF-a) 3. Start using any type of nutritional supplement and anti-inflammatory drugs 4. Cure for diseases that require special treatments that interfere with the intervention. 5- Pregnancy during the study 6- Patients whose compliance and consumption of saffron powder or placebo by them is less than 80% recommended by the host.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hs-crp. Timepoint: Before intervention and 3 months after intervention. Method of measurement: ELISA kit in ng / ml.;ALT. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzymatic photometric.;AST. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzymatic photometric. | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist to hip ratio (WHR). Timepoint: Before the intervention and three months after the intervention. Method of measurement: calculation.;TNF-a. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in pg / ml.;TAC. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Using the kits and colorimetric method in umol / L.;Adiponectin. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in ng / ml.;Leptin. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in ng / ml.;Malondialdehyde (MDA). Timepoint: Before the intervention and three months after the intervention. Method of measurement: Colorimetric method ng / ml.;Weight. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Digital scale in kilograms.;Body mass index (BMI). Timepoint: Before the intervention and three months after the intervention. Method of measurement: Calculation / in kg / m2.;Waist. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Meter in cm.;Hip circumference. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Meter in cm.;Body fat percentage. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ebody device BIA method. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr naheed aryaeian
Iran University of Medical Sciences
Outcome results
None listed