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IRCT20201129049534N12 IRCT 2026-04-13 Esfahan University of Medical Sciences The effect of Calebin-A supplementation in patients with metabolic dysfunction-associated steatotic liver disease The effect of Calebin-A supplementation on cardiometabolic risk factors, liver function tests, sonographic findings, and quality of life among patients with metabolic dysfunction-associated steatotic liver disease (MASLD): a double-blind randomized controlled clinical trial 2026-04-21 anticipated 90 Recruiting https://irct.ir/trial/89233 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize, stratified block randomization using blocks of 4 will be used. Also, matching will be done based on BMI (<25 and >25). For randomization using the site (https://sealedenvelope.com/simple-randomiser/v1) after determining the number of blocks and BMI (as variable based on which matching will be performed), all The blocks will be specified along with the type of intervention and the order of allocation of the intervention. The random allocation list of patients will be in the sole possession of an individual outside the plan, Blinding description: In order to conduct this research in a double-blind manner, before the study begins, all relevant capsules are coded as A and B by someone other than the researcher, so that the researcher is unaware of the type of capsules received by both groups. In this way, participants and outcome assessors will not be aware of the patient grouping and will be blinded to it. 3 Metabolic dysfunction associated steatotic liver disease. 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. Intervention 2: Control group: they will receive two placebo capsules daily (each capsule containing 25 mg of maltodextrin plus 5 mg of piperine, produced by Sami Lab, India) for 12 weeks. Yes - There is a plan to make this available What will be shared: Information about the study will be published after the individuals are not identified and the project is completed. When: Access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Bagherniya email: bagherniya@nutr.mui.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided. Comments:
public Mohammad Bagherniya
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3154 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3154 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 65 years Both 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 K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo 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. Control group: they will receive two placebo capsules daily (each capsule containing 25 mg of maltodextrin plus 5 mg of piperine, produced by Sami Lab, India) for 12 weeks. 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. 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. Esfahan University of Medical Sciences Approved 2026-02-18 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)