non alcoholic fatty liver disease. K75.8
Conditions
Interventions
Intervention 1: Intervention group: 2 synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day for 3 months. Intervention 2: Control group: 2 placebo capsule containing 1gra
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria for the study: Age >18 years old; Fill out the form consent and approve it; Controlled Attenuation Parameter (CAP score)>263; Having a history of alcohol consumption less than 10 mg per day in women and less than 20 mg per day in men; Absence of other acute and chronic diseases and disorders of the liver (hepatitis B, C, etc.), biliary disease, known autoimmune diseases, cancer and inherited disorders affecting liver condition (storage disease of iron, and copper. ..); Absence of Hypertension, cardio - vascular diseases, lung disease and kidney disease, cirrhosis and celiac disease; Absence of pregnancy or lactation, athletes or hospitalization; Not consume medications such as metformin, vitamin E and Ursodeoxycholic Acid (UDCA); Not consume hepatotoxic drugs such as phenytoin, tamoxifen and lithium and corticosteroids and methotrexate; Not consume medications of antibiotics over a week during the study period or before entering it; No history of weight loss surgery in the past year the 3-month weight loss program; No history of hypothyroidism, Cushing's syndrome and diabetes , lack of gall bladder disease. Exclusion Criteria for the study: Food intolerance and unlikely side effects from taking supplements; pregnancy..
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;Total cholestrol. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;HDL-C. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;TG. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;FBS. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;Serum insulin. Timepoint: Begining and end of intervention. Method of measurement: Radioimmunoassay.;AST. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;ALT. Timepoint: Begining and end of intervention. Method of measurement: enzymatic methods using kits.;HOMA. Timepoint: Begining and end of intervention. Method of measurement: Calculation.;TNF-a. Timepoint: Begining and end of intervention. Method of measurement: Elisa.;Steatosis. Timepoint: Begining and end of intervention. Method of measurement: ultrasonography.;Fibrosis. Timepoint: Begining and end of intervention. Method of measurement: fibroscan. | — |
Secondary
| Measure | Time frame |
|---|---|
| SFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;MUFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;PUFA. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;Carbohydrate intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;Protein intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day.;Fat intake. Timepoint: Begining and end of intervention. Method of measurement: questionnaire gram per day. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzita Hekmatdoost
Shahid Beheshti University of Medical Sciences
Outcome results
None listed