Fatty liver disease. Nonalcoholic steatohepatitis (NASH)
Conditions
Interventions
Intervention 1: Intervention group: The intervention group was simultaneously administered a low-carbohydrate diet and time-restricted feeding (16 hours of fasting and 8 hours for food consumption) fo
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 and above Hepatic steatosis grade 2 or higher based on Fibro scan results (CAP score >263) Not having a history of alcohol consumption or consuming less than 10 mg of alcohol per day in women and less than 20 mg per day in men. No insulin treatment Having the desire to participate in the study and the ability to complete the study steps Absence of other chronic and acute liver diseases and disorders (hepatitis B, C, etc.), biliary disease, kidney diseases, endocrine disorders, known autoimmune diseases, cancer, and hereditary disorders affecting the liver (hemochromatosis, Wilson's, etc.) Absence of cardiovascular disease, chronic inflammatory disease and disorders of the digestive system affecting absorption (celiac disease, etc.) Absence of pregnancy or breastfeeding in women Not receiving corticosteroid drugs such as Prednisolone, Hydrocortisone and Betamethasone Not taking hepatotoxic drugs such as Tamoxifen, Phenytoin and Lithium Not taking fiber, omega-3 and antioxidant supplements during the last 6 months Not taking drugs or weight loss supplements No history of weight loss surgery or weight loss program in the last 3 months Absence of liver cirrhosis or Fibro score higher than 12
Exclusion criteria
Exclusion criteria: Changes in medications (blood lipid-lowering drugs, blood sugar control drugs) during the study period Weight loss of more than 10% during the last 6 months Weight loss of more than 10% during the study period Unwillingness to participate in the study or non-adherence to the prescribed regimens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAP (Controlled Attenuation Parameter) Score. Timepoint: At the beginning of the study and week 12. Method of measurement: The result of the fibro scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of hepatic steatosis. Timepoint: The beginning of the study and week 12. Method of measurement: Based on the results of the fibro scan.;The degree of liver fibrosis. Timepoint: The beginning of the study and week 12. Method of measurement: Based on the results of the fibro scan.;Alanine transaminase. Timepoint: The beginning of the study and week 12. Method of measurement: Enzymatic method using kit.;Aspartate aminotransferase. Timepoint: The beginning of the study and week 12. Method of measurement: Enzymatic method using kit.;Serum triglycerides. Timepoint: The beginning of the study and week 12. Method of measurement: Enzymatic method using kit.;Total serum cholesterol. Timepoint: The beginning of the study and week 12. Method of measurement: Enzymatic method using kit.;Serum Low-density lipoprotein (LDL). Timepoint: The beginning of the study and week 12. Method of measurement: Enzymatic method using kit.;Serum High-density lipoprotein (HDL). Timepoint: The beginning of the study and week 12. Method of measurement: Enzymatic method using kit.;Serum High-sensitivity C-reactive protein (hs-CRP). Timepoint: The beginning of the study and week 12. Method of measurement: ELISA method.;Serum glucose. Timepoint: The beginning of the study and week 12. Method of measurement: Enzymatic method using kit.;Serum insulin. Timepoint: The beginning of the study and week 12. Method of measurement: Radioimmunoassay.;Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Timepoint: The beginning of the study and week 12. Method of measurement: Calculation.;Quantitative Insulin Sensitivity Check Index (QUICKI). Timepoint: The beginning of the study and week 12. Method of measurement: Calculation.;Type of diet received. Timepoint: The beginning of the study. Method of measurement: Data collection form.;Weight. Timepoint: The beginning of the study and week 12. Method of measurement: Weight scale.;Height. Timepoint: The beginning of the study. Method of measuremen | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzita Hehmatdoost
Shahid Beheshti University of Medical Sciences
Outcome results
None listed