Document Type : Original Article
Authors
1
Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
2
Applied Biomedical Research Center, Basic Sciences Research Institute, Mashhad University of Medical Sciences Mashhad, Iran.
3
Center for Research Impact & Outcome, Chitkara College of Pharmacy, Chitkara University, Rajpura, Punjab 140401, India.
4
Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
5
Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
6
Clinical Research Development Unit, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
7
Department of Radiology, Faculty of Medicine, Islamic Azad University-Mashhad Branch, Mashhad, Iran.
8
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Abstract
Introduction: Metabolic syndrome (MetS) and metabolic dysfunction-associated steatotic liver disease (MASLD) are common in severe obesity and increase postoperative complications after bariatric surgery. Curcumin, a polyphenolic compound with antioxidant and anti-inflammatory properties, has shown potential to improve metabolic and hepatic parameters; however, its effects have not been specifically investigated in bariatric surgery candidates with concurrent MetS and MASLD. Piperine, a bioavailability enhancer, may augment its effects by inhibiting glucuronidation and cytochrome P450 enzymes involved in curcumin metabolism.
Objective: We hypothesized that 8-week curcumin-piperine supplementation would improve metabolic syndrome components and hepatic steatosis and fibrosis indices compared with placebo in bariatric surgery candidates.
Methods: A randomized, placebo-controlled trial will be conducted at Imam Reza Hospital, Mashhad, Iran, in bariatric surgery candidates with MASLD and MetS. Participants will be randomly assigned to receive curcumin-piperine or placebo for 8 weeks preoperatively. The primary outcome domains are MetS-related parameters and MASLD-related hepatic outcomes. Hepatic steatosis and fibrosis will be assessed by two-dimensional shear wave elastography at baseline and six months post-surgery. Intraoperative liver biopsy will be obtained once, at the time of surgery, for histological characterization, and is not a longitudinal primary efficacy measure. Additionally, components of MetS including anthropometric indices, glycemic control, blood pressure, and lipid profile, will be assessed at baseline, post-intervention, and six months after surgery.
Results: This is a study protocol; therefore, no results are available. The study is ongoing, and results will be reported upon completion.
Conclusion: This protocol targets a high-risk population with severe obesity and metabolic dysfunction. The results of this trial will provide evidence regarding the potential role of curcumin-piperine supplementation in modulating metabolic and hepatic outcomes among bariatric surgery candidates.
Keywords
Acknowledgments: The authors thank the Clinical Research Development Unit of Ghaem Hospital for cooperation in drafting the manuscript.
Availability of data and materials: The data generated and analyzed during the current study are available from the corresponding author upon reasonable request.
Conflict of interest: The authors declare no competing interests.
Consent for publication: Not applicable.
Funding: This study was funded by Mashhad University of Medical Sciences, Mashhad, Iran (grant number: 4020651). The funding body had no role in the design, data collection, analysis, interpretation, or writing of the manuscript.
Ethics declarations: The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. The trial was approved by the Research Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.MEDICAL.REC.1402.318). It was registered with the Iranian Registry of Clinical Trials (IRCT) in November 2023 under the registration number IRCT20231116060076N1.
Author Contributions: All authors contributed to the study conception and design, data collection, data analysis and interpretation, and manuscript preparation. All authors reviewed and approved the final version of the manuscript.
Open Access Policy: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/
