Non-alcoholic fatty liver disease (NAFLD). Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Daily intake of one 500 mg synbiotic capsule (produced by Zist Takhamir) and one 2000 IU vitamin D tablet (produced by Darou Salamat Pharmed) with lunch for 12 week
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnosis of fatty liver based on the fibroscan test by a gastroenterology specialist. BMI between 25 and 35 No use of antibiotics in the past 6 weeks No intake of vitamin D supplements, probiotics, or synbiotics in the past 6 weeks Patients aged between 18 and 65 years Not pregnant or breastfeeding No history of any other chronic diseases such as kidney or liver failure, cancer, etc Willingness, consent, and ability to participate in and complete the study, as well as cooperate with the researcher
Exclusion criteria
Exclusion criteria: Vitamin D levels higher than 50 ng/dl in the last 3 months Vitamin D levels lower than 12 ng/dl in the last 3 months Following weight loss diets over the past 3 months Use of corticosteroids, non-steroidal anti-inflammatory drugs, and oral contraceptives Individuals with immune disorders, short bowel syndrome (SBS), inflammatory bowel disease Individuals with a central venous catheter or heart valve disease Pregnant individuals or those expecting to get pregnant during the study, as well as breastfeeding mothers Individuals receiving unspecified medications, supplements, or antibiotics during the study Individuals deemed by the researcher to have psychological, medical, and medication profiles that may compromise their mental and physical health during the study (such as those with severe anxiety, severe depression, mania, dementia, a history of drug or alcohol addiction) Insufficient education and ability to participate in the interview Individuals with hypothyroidism or other thyroid disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipid profile. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: TC and TG serum concentrations will be measured using laboratory methods, respectively, through enzymes such as cholesterol esterase, cholesterol oxidase, and glycerol phosphate oxidase and using standard kits. HDL will be measured after precipitation of Apolipoprotein B, which includes lipoproteins, with phosphotungstic acid. The amount of LDL will be measured using the values of TC, TG, HDL and by existing formulas.;Vitamin D. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: ELISA test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood sugar indicators. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Before and after the end of the intervention, 10 ml of blood samples are taken from each person in a 12-hour fasting state, and the serum sample is separated from the whole blood by a centrifuge for 10 minutes at 3500 rpm. The serum and whole blood samples are immediately frozen at -70°C until the relevant tests are performed. The standard enzyme method with commercial kits available in the market (Pars Azmon) is used to calculate insulin and FBS, HbA1c is checked by measuring in whole blood by cation exchange chromatography and using the Nyco Card HbA1c kit (Oslo, Norway).;Weight. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Seca scale.;Body mass index(BMI). Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Weight (kg) divided by height squared (square meters).;Waist circumference. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Measuring tape.;Hip circumference. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Measuring tape.;Systolic blood pressure. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Sphygmomanometer.;Diastolic blood pressure. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Sphygmomanometer.;Quality of life index. Tim | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarzad Shidfar
Iran University of Medical Sciences
Outcome results
None listed