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IRCT20100524004010N40 IRCT 2025-03-15 Shahid Beheshti University of Medical Sciences Combined effect of Low Carbohydrate Diet (LCD) with Time-restricted feeding (TRF) on anthropometric indicators, liver parameters, metabolic indices and inflammation in patients with non-alcoholic fatty liver Combined effect of Low Carbohydrate Diet (LCD) with Time-restricted feeding (TRF) on anthropometric indicators, liver parameters, metabolic indices and inflammation in patients with non-alcoholic fatty liver 2025-03-30 anticipated 50 Complete https://irct.ir/trial/82238 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The table of random numbers is used to classify people into intervention and control groups. N/A Fatty liver disease. 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) for 12 weeks. The diet is tailored to each individual's calorie needs. Individuals are provided with recommendations for general health, liver health, and physical activity. Intervention 2: Control group: Patients in the control group only receive dietary recommendations related to general health and liver health and physical activity. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided.
public Azita Hehmatdoost
No. 7, Shahid Hafezi Ave., Farahzadi Blvd., Western Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No. 7, Shahid Hafezi Ave., Farahzadi Blvd., Western Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 K75.81 Nonalcoholic steatohepatitis (NASH) Treatment - Other Treatment - Other 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) for 12 weeks. The diet is tailored to each individual's calorie needs. Individuals are provided with recommendations for general health, liver health, and physical activity. Control group: Patients in the control group only receive dietary recommendations related to general health and liver health and physical activity. CAP (Controlled Attenuation Parameter) Score. Timepoint: At the beginning of the study and week 12. Method of measurement: The result of the fibro scan. 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 measurement: Stadiometer. Body mass index (BMI). Timepoint: The beginning of the study and week 12. Method of measurement: Calculation. Sex. Timepoint: The beginning of the study. Method of measurement: Observation. Age. Timepoint: The beginning of the study. Method of measurement: Question. Smoking. Timepoint: The beginning of the study. Method of measurement: Question. Total energy intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Carbohydrate intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Protein intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Total fat intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Cholesterol intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Saturated fatty acids (SFA) intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Monounsaturated fatty acids (MUFA) intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Polyunsaturated fatty acids (PUFA) - omega 3 intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Polyunsaturated fatty acids (PUFA) - omega 6 intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Fiber intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Vitamin E intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Vitamin C intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Zinc intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Selenium intake. Timepoint: The beginning of the study, week 6 and 12. Method of measurement: 24-hour food recall questionnaire (2 working days and 1 day off). Physical activity. Timepoint: The beginning of the study and week 12. Method of measurement: Metabolic equivalent of task (MET) questionnaire. Waist circumference. Timepoint: The beginning of the study and week 12. Method of measurement: Tape measure. Hip circumference. Timepoint: The beginning of the study and week 12. Method of measurement: Tape measure. Shahid Beheshti University of Medical Sciences Approved 2025-01-22 Ethics committee of National Nutrition and Food Technology Research Institute (NNFTRI) No. 7, Shahid Hafezi Ave., Farahzadi Blvd., Western Qods Town Tehran Tehran Iran (Islamic Republic of)