The present study is a double blind clinical trial. After approving the research in the ethics committee of the Vice-Chancellor of Research and Technology of Iran University of Medical Sciences and obtaining necessary permits, the participants from among the patients referred to Gastroenterology clinic of Rasoul-e-Akram Medical Center, That are based on liver ultrasound and blood tests, non-alcoholic fatty liver in them, who are willing to cooperate and enter the study, are selected and after explaining all stages of the research project and signing the consent form enter the design be.
At the beginning of the study, 15 cc of venous blood from patients will be taken after 10-12 hours of fasting, which will be freeze After separating the serum, it is freeze at -80 ° C,. Public data forms (age, sex , Height, weight, BMI, waist circumference, hip circumference, smoking, duration of disease, fatty liver severity, blood pressure, etc.), the 24-hour recall of the feed and the IPAQ physical activity questionnaire are completed, as well as the patients Body fat percentage will be evaluated with ebody. At the end of the research, forms and measurements will be carried out again. Also, the weight loss regimen is individually adjusted for each person at the beginning of the study. Regarding the protocol for treating non-alcoholic fatty liver, a physical activity of 30 minutes, one day is recommended.
Participants will be randomly divided into two groups: 1- An intervention group consisting of 38 males and females with non-alcoholic fatty liver who will receive 100 mg of saffron for 12 weeks during the study; . 2. Control group of Includes 38 males and females with non-alcoholic fatty liver that will be treated with placebo tablets containing dextrose malto during the intervention. The placebo will be in any shape, size, and color, and the packaging indistinguishable from saffron tablets.
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-α)
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.
Applied Objectives: If the effect of saffron powder on hs-CRP TNF-α, MDA, TAC, body composition, adiponectin and leptin (inflammatory and oxidative stress markers, body composition and adipokines) can be used as an auxiliary substance in Along with other treatments to improve disorders in patients with non-alcoholic fatty liver