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IRCT20170315033086N12 IRCT 2024-09-19 Shahid Beheshti University of Medical Sciences Investigating the effect of CAPRIDIN in the treatment of metabolic fatty liver Investigation of the Impact of CAPRIDIN Consumption Containing Medium-Chain Fatty Acids on Biochemical Metabolic Pathways and Inflammatory Responses in Individuals Affected by Metabolic Associated Steatotic Liver Disease (MASLD) 2024-09-22 anticipated 20 Complete https://irct.ir/trial/78401 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: To randomly allocate patients to the intervention and control groups, the “Random Allocation V.2” software (available for download at https://random-allocation-software.software.informer.com) will be used. In this study, block randomization with a block size of 4 will be employed. This means that patients will be randomly assigned to the intervention and control groups in blocks of 4. In this study, there are 20 participants, with 10 in the intervention group and 10 in the control group. 1-2 Metabolic dysfunction-associated steatotic liver disease. Intervention 1: Patients with Metabolic dysfunction–associated steatotic liver disease (MASLD) who, following a comprehensive education session about the composition, on average consume 0.5 milliliters of CAPRIDIN per kilogram of body weight daily for two months, along with their meals. CAPRIDIN is a Kondor Pharma (Canada) product that contains medium-chain fatty acids. These compounds are used in ketogenic diets and induce ketogenesis. Ketogenic-based treatments are employed in controlling metabolic-related diseases such as obesity. The intervention group is advised to limit carbohydrate sources in their daily diet. To reduce dietary carbohydrate sources, patients are given general instructions. Given that MASLD does not have a standard treatment and most therapeutic approaches are based on lifestyle changes and weight loss, there are no contraindications for using potential treatments such as cholesterol and triglyceride-lowering medications, according to the treating physician. If patients take these medications, the selection of the intervention and control groups will be equal in terms of medication use. Intervention 2: Control group: Patients with metabolic-associated fatty liver disease (MASLD) who do not receive any CAPRIDIN-containing regimen. Given that MASLD does not have a standard treatment and most therapeutic approaches are based on lifestyle changes and weight loss, there are no contraindications for the use of potential treatments such as cholesterol and triglyceride-lowering medications, according to the treating physician. Yes - There is a plan to make this available What will be shared: All study data can be published after the de-identification of subjects. When: Access begins 1 year after the publication of the results To whom: The data will be made available to academic researchers Conditions: There is no special restriction in this case Where to obtain: To receive the data, the request must be sent via email to the person responsible for the project How to obtain: After the approval of the project manager and colleagues, the data will be provided to the applicant. Comments:
public Saeed Karima
Department of Clinical Biochemistry, Shahid Beheshti University of Medical Sciences, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2387 2570 karima@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Behzad Hatami
Taleghani Hospital, Yaman St., Arabi St., Chamran Highway, Volanjak, Tehran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2519 bzd_hatami@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Individuals diagnosed with Metabolic Associated Steatotic Liver Disease based on laboratory results, imaging techniques, and specialist physician confirmation. 15 years 65 years Both Any previous consumption of the ketogenic diets History of alcohol consumption pregnancy K75.8 Other specified inflammatory liver diseases, Nonalcoholic steatohepatitis [NASH] Other N/A Patients with Metabolic dysfunction–associated steatotic liver disease (MASLD) who, following a comprehensive education session about the composition, on average consume 0.5 milliliters of CAPRIDIN per kilogram of body weight daily for two months, along with their meals. CAPRIDIN is a Kondor Pharma (Canada) product that contains medium-chain fatty acids. These compounds are used in ketogenic diets and induce ketogenesis. Ketogenic-based treatments are employed in controlling metabolic-related diseases such as obesity. The intervention group is advised to limit carbohydrate sources in their daily diet. To reduce dietary carbohydrate sources, patients are given general instructions. Given that MASLD does not have a standard treatment and most therapeutic approaches are based on lifestyle changes and weight loss, there are no contraindications for using potential treatments such as cholesterol and triglyceride-lowering medications, according to the treating physician. If patients take these medications, the selection of the intervention and control groups will be equal in terms of medication use Control group: Patients with metabolic-associated fatty liver disease (MASLD) who do not receive any CAPRIDIN-containing regimen. Given that MASLD does not have a standard treatment and most therapeutic approaches are based on lifestyle changes and weight loss, there are no contraindications for the use of potential treatments such as cholesterol and triglyceride-lowering medications, according to the treating physician. Serum alanine aminotransferase level. Timepoint: One time at the beginning of the study and one time after two months. Method of measurement: Enzymatic method. Serum level of interleukin 1 beta. Timepoint: One time at the beginning of the study and one time after two months. Method of measurement: Elisa method. Behbalin Inc. Approved 2024-07-31 Ethics Committee of Faculty of Medicine, Shahid Beheshti University of Medical Sciences and Healths Shahid Chamran highway - Evin - next to Taleghani hospital - medical school - ground floor Tehran Tehran Iran (Islamic Republic of)