Metabolic dysfunction associated steatotic liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: they will receive two Calebin A capsules daily (each capsule containing 25 mg of Calebin A plus 5 mg of piperine, produced by Sami Lab, India) for 12 weeks. Interve
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 80 years Patients with MSLD (hepatic steatosis and one of the 5 factors of metabolic disorder) based on the confirmation of a radiologist and gastroenterologist. Having a FIB-4 index higher than 1.3 using lab data related to maximum a month ago Consent of the patient to participate in the study
Exclusion criteria
Exclusion criteria: Alcohol consumption of more than 30 gr/day in men and more than 20 gr/day in women Patients taking ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids, and methotrexate Taking vitamin E, omega-3, and probiotic supplements within the past 3 months Pregnancy and breastfeeding Uncontrolled or insulin-dependent diabetes Patients with liver cirrhosis, hepatitis, bile duct obstruction, immune system, Cushing's syndrome, cancer, and iron and copper storage disorders Weight loss diet in the last 3 months or weight loss surgery in the last year Starting a new medication or changing the dosage of previous medications associated with hepatic steatosis The patient's unwillingness to continue participating in the study Occurrence of any adverse events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine Aminotransferase (ALT). Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;Aspartate Aminotransferase (AST). Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;Alkaline Phosphatase (ALP). Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;Gamma-Glutamyl Transferase (GGT). Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;C reactive Protein (CRP). Timepoint: Before and after intervention. Method of measurement: ELISA test.;Interleukin-6 (IL-6). Timepoint: Before and after intervention. Method of measurement: ELISA test.;Malondialdehyde (MDA). Timepoint: Before and after intervention. Method of measurement: ELISA test.;Total antioxidant capacity (TAC). Timepoint: Before and after intervention. Method of measurement: ELISA test.;Superoxide dismutase (SOD). Timepoint: Before and after intervention. Method of measurement: ELISA test.;Fatty liver index. Timepoint: Before and after intervention. Method of measurement: Based on the standard formula.;Aspartate aminotransaminase-to-platelet ratio index. Timepoint: Before and after intervention. Method of measurement: Based on the standard formula.;Fibrosis-4 index. Timepoint: Before and after intervention. Method of measurement: Based on the standard formula. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood sugar (FBS). Timepoint: Before and after intervention. Method of measurement: enzymatic colorimetric assay.;Fasting Insulin. Timepoint: Before and after intervention. Method of measurement: enzyme immunoassay.;Homeostasis model assessment-estimated insulin resistance (HOMA-IR). Timepoint: Before and after intervention. Method of measurement: fasting insulin (mIU/mL) ×fasting blood glucose (mg/dL)/405.;Total cholestrol. Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;High-Density Lipoprotein. Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;Low-Density Lipoprotein. Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;Triglyceride. Timepoint: Before and after intervention. Method of measurement: Commercial diagnostic kit.;Fatty liver grade based on ultrasound. Timepoint: Before and after intervention. Method of measurement: ultrasound.;Quality of life. Timepoint: Before and after intervention. Method of measurement: Short Form Health Survey (SF-36).;Sleep Quality. Timepoint: Before and after intervention. Method of measurement: Pittsburgh Sleep Quality Index.;Depression, anxiety and stress. Timepoint: Before and after intervention. Method of measurement: Depression anxiety stress scales-21 (DASS-21).;Body mass index. Timepoint: Before and after intervention. Method of measurement: weight/ (height)2.;Waist circumference. Timepoint: Before and after intervention. Method of measurement: Using a non-elastic tape measure, without applying any pressure, approximately 0.1 cm at the narrowest part of the waist (at the end of a natural exhalation) in a standing position. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Bagherniya
Esfahan University of Medical Sciences
Outcome results
None listed