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IRCT20201129049534N11 IRCT 2025-06-26 Esfahan University of Medical Sciences The effects of trehalose on CABG patient Evaluation of the effectiveness of trehalose on inflammatory factors, cardiac biomarkers and clinical outcomes after coronary artery bypass graft (CABG) surgery: A double-blind randomized controlled clinical trial 2025-08-06 anticipated 90 Complete https://irct.ir/trial/82657 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into two groups, intervention and control, using a stratified block randomization. The following reliable site will be used to allocate the intervention in the above-mentioned manner. https://www.sealedenvelope.com/simple-randomiser/v1/lists In this way, individuals will be randomly divided into two groups, intervention and control, using blocks of four and based on age and gender, Blinding description: In order to conduct this research in a double-blind manner, before the start of the study, all the relevant sachets are coded as A and B by someone other than the researcher so that the researcher does not know the type of sachets received by both groups. The trehalose sachets are purchased from Shaanxi Fruiterco Biotechnology Co., Ltd. China . The trehalose and placebo sachets are completely identical in terms of type, color, shape and size. 3 Cardiovascular disease. Intervention 1: Intervention group: Patients who receive three sachets daily, each containing 10 grams of trehalose purchased from Shaanxi Fruiterco Biotechnology Co., Ltd. China, for 5 days (total of 30 grams of trehalose per day). In the groups, one sachet is given to the patient at 6 am, one sachet at 2 pm, and one sachet at 10 pm, along with gavage (if enteral nutrition is used) or half an hour after the main meal (if oral nutrition is used). In order to comply with ethical principles, no intervention is performed in the field of drug therapy of the patients. Intervention 2: Control group: Control group: Patients who receive three sachets daily, each containing 10 grams of maltodextrin purchased from Espinas Shimi Co. Iran, (total 30 grams of maltodextrin daily) for 5 days. In the groups, one sachet is given to the patient at 6 am, one sachet at 2 pm, and one sachet at 10 pm, along with gavage (if enteral nutrition is used) or half an hour after the main meal (if oral nutrition is used). In order to comply with ethical principles, no intervention is made in the field of drug therapy of the patients. Yes - There is a plan to make this available What will be shared: Study information will be published after the individuals are unidentified and after the project is completed. When: Access period starts six months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Baghernia 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
Chamran Hospital, Salman Farsi Street
Isfahan Iran (Islamic Republic of) 8166173414 +98 31 3260 0961 heart@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Chamran Hospital, Salman Farsi Street
isfahan Iran (Islamic Republic of) 8166173414 +98 31 3260 0961 heart@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Non-emergency coronary artery bypass surgery Age 30-80 years Gastrointestinal normal function and with intestinal or oral nutrition criteria Ejection fraction (EF) above 30% Arrest Time (cardiac resuscitation) 30 to 90 minutes Willingness to participate in the study and complete the consent form before surgery 30 years 80 years Both Taking herbal supplements (as a supplement) during 3 months before the operation Requires balloon pump Adding another operation in addition to coronary artery bypass surgery(CABG), like simultaneous valve operation Patients with a history of underlying disease such as congenital and immune disorders and pancreatitis Diabetic patients who require insulin injections to control blood sugar or have uncontrolled diabetes. Pregnancy and lactation Z95.1 Presence of aortocoronary bypass graft Treatment - Drugs Placebo Intervention group: Patients who receive three sachets daily, each containing 10 grams of trehalose purchased from Shaanxi Fruiterco Biotechnology Co., Ltd. China, for 5 days (total of 30 grams of trehalose per day). In the groups, one sachet is given to the patient at 6 am, one sachet at 2 pm, and one sachet at 10 pm, along with gavage (if enteral nutrition is used) or half an hour after the main meal (if oral nutrition is used). In order to comply with ethical principles, no intervention is performed in the field of drug therapy of the patients. Control group: Control group: Patients who receive three sachets daily, each containing 10 grams of maltodextrin purchased from Espinas Shimi Co. Iran, (total 30 grams of maltodextrin daily) for 5 days. In the groups, one sachet is given to the patient at 6 am, one sachet at 2 pm, and one sachet at 10 pm, along with gavage (if enteral nutrition is used) or half an hour after the main meal (if oral nutrition is used). In order to comply with ethical principles, no intervention is made in the field of drug therapy of the patients. C reactive Protein (CRP). Timepoint: At baseline (before the start of the intervention) and on the fifth day (end of the intervention). Method of measurement: ELISA test. Lactate Dehydrogenase (LDH). Timepoint: At baseline (before the start of the intervention) and on the fifth day (end of the intervention). Method of measurement: ELISA test. Interleukin 6 (int-6). Timepoint: At baseline (before the start of the intervention) and on the fifth day (end of the intervention). Method of measurement: ELISA test. Creatine Kinase-MB. Timepoint: At baseline (before the start of the intervention) and on the fifth day (end of the intervention). Method of measurement: ELISA test. Atrial fibrillation. Timepoint: On the fifth day (end of the intervention). Method of measurement: Electrocardiogram (ECG or EKG). 28-days mortality rate. Timepoint: 28 days after coronary artery bypass surgery. Method of measurement: Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up. Fasting Blood Sugar. Timepoint: At baseline (before the start of the intervention) and on the fifth day (end of the intervention). Method of measurement: Photometric. Cell Blood Count. Timepoint: At baseline (before the start of the intervention) and on the fifth day (end of the intervention). Method of measurement: Auto hematology analyzers. Isfahan University of Medical Sciences Approved 2025-03-10 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences School of Medicine, Isfahan University of Medical Sciences, Hezar-jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)