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IRCT20231116060076N1 IRCT 2023-11-30 Mashhad University of Medical Sciences Investigating the therapeutic effect of curcumin-peperin supplementation on metabolic syndrome, and liver fibrosis and steatosis Investigating the therapeutic effect of curcumin-peperin supplementation on metabolic syndrome, and liver fibrosis and steatosis indicators in bariatric surgery candidates: a randomized controlled trial. 2023-12-11 anticipated 110 Complete https://irct.ir/trial/73949 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, food intake using a 24-hour food recall questionnaire and physical activity using the international IPAQ questionnaire will be examined as confounding variables before the intervention and 6 months after surgery, Randomization description: Block randomization with blocks of 4 and 6 will be done using special randomization sites such as sealed envelopes. After specifying the codes, each code is written separately on a sheet. Each sheet is placed in a separate envelope or folded and glued in such a way that it cannot be seen inside (allocation concealment). After obtaining informed consent, a sheet will be removed from each qualified patient and according to the code written in it, people will be placed in two study groups, Blinding description: The patient receives the drug (intervention or control group) in sealed envelopes that are coded. Coding is done by one of the collaborators of the project and the patient, researcher and analyst are blinded. 2 Metabolic syndrome, liver fibrosis and steatosis. Intervention 1: Intervention group: includes 55 morbidly obese patients who are candidates for bariatric surgery and who meet the study entry criteria, who will be given a daily supplement containing 500 mg of curcumin and 5 mg of peprine for 8 weeks. Intervention 2: Control group: It includes 55 patients with morbid obesity and candidates for bariatric surgery who meet the inclusion criteria and will be given a placebo daily for 8 weeks. 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 There is no further information.
public Mohadeseh Hassan zadeh
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 hasanzadehm4001@mums.ac.ir Mashhad University of Medical Sciences scientific Reza Rezvani
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 RezvaniR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with morbid obesity and candidates for bariatric surgery in the age range of 18 to 65 years Diagnosis of metabolic syndrome by a specialist physician based on biochemical and clinical analyses Diagnosis of metabolically dysfunction–associated fatty liver disease (MASLD) through ultrasound, biochemical and clinical analyses by a specialist physician Willingness to cooperate in the project No known allergies to curcumin or turmeric 18 years 65 years Both Regular consumption of multivitamin-mineral supplements, antioxidants, and omega-3 supplements in amounts exceeding the daily requirement, probiotic supplements, and consumption of herbal extracts such as silymarin during the past 3 months. Diagnosed pathological conditions affecting the liver such as types of viral hepatitis and liver transplantation History of gastrointestinal diseases, organ failure, thyroid disorders, kidney diseases, autoimmune diseases, severe mental diseases and types of malignancy. E88.8, K74 Metabolic syndrome, Hepatic fibrosis, Hepatic steatosis, Treatment - Drugs Treatment - Drugs Intervention group: includes 55 morbidly obese patients who are candidates for bariatric surgery and who meet the study entry criteria, who will be given a daily supplement containing 500 mg of curcumin and 5 mg of peprine for 8 weeks. Control group: It includes 55 patients with morbid obesity and candidates for bariatric surgery who meet the inclusion criteria and will be given a placebo daily for 8 weeks. Fasting plasma glucose. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay. 2. Triglyceride. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay. High Density Lipoprotein (HDL). Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay. Blood Pressure. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Mercury sphygmomanometer. Anthropometric measurements. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Height will be measured without shoes, with an accuracy of 0.5 cm, using a caliper. Weight, BMI, and waist-to-hip ratio will be measured using a bioelectrical impedance analyzer. Degree of hepatic steatosis or fibrosis. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Liver elastography will be performed before the intervention and 6 months after surgery. Also, a liver biopsy will be performed at the end of the intervention (during surgery). Liver enzymes (ALT, AST, ALP). Timepoint: All variables will be measured at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay. Checking insulin resistance based on the HOMA-IR formula. Timepoint: All variables will be measured at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: It will be measured by collecting a fasting blood sample at any time point and measuring fasting blood insulin and glucose levels using the formula HOMA-IR = [Fasting Glucose (mg/dL) x Fasting Insulin (mU/L)] / 405. Mashhad University of Medical Sciences Approved 2023-09-23 Ethics committee of Mashhad University of Medical Sciences Qureshi Building, University Street, Mashhad, Khorasan Razavi mashhad Razavi Khorasan Iran (Islamic Republic of)