Document Type : Original Article
Authors
1
Department of Clinical 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
Centre for Research Impact & Outcome, Chitkara College of Pharmacy, Chitkara University, Rajpura 140401, Punjab, India.
4
Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
5
Pediatric Endocrinology Specialist
6
Department of Nutrition Sciences, Varastegan Institute for Medical Sciences, Mashhad, Iran.
7
Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
8
Clinical Research Development Unit, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
Abstract
Background: The incidence of obesity and metabolic syndrome has been rising among the pediatric population, and these metabolic disturbances are associated with complications that persist into adulthood. Regulating energy intake is therefore fundamental for both prevention and treatment. Curcumin, a compound derived from turmeric with anti-inflammatory and antioxidant properties, and piperine, a bioavailability-enhancing alkaloid from black pepper, have both been explored for use in various non-communicable diseases in adults.
Objectives: This study aims to evaluate the effects of curcumin-piperine supplementation on metabolic syndrome and body mass index in children.
Methods: This is a randomized, triple-blind, placebo-controlled trial with a parallel two-arm design. Participants aged 7–18 years who meet at least three Cook criteria for metabolic syndrome will be recruited from a pediatric endocrinology clinic. The intervention group will receive one tablet daily containing 500 mg curcumin and 5 mg piperine for three months, while the control group will receive a microcrystalline cellulose placebo. The primary outcomes are improvement in metabolic syndrome status and body mass index (BMI). Secondary outcomes include other anthropometric indices, laboratory parameters (triglycerides, fasting glucose, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), liver enzymes (ALT and AST), fasting insulin, and HbA1c), insulin resistance indices (HOMA-IR and QUICKI), and blood pressure.
Conclusion: While findings on inflammatory markers and metabolic syndrome in adults are promising, they are heterogeneous, and pediatric studies are limited. The use of curcumin with piperine may produce more discernible effects on lipid and metabolic profiles due to improved bioavailability. The results of this trial may help generate hypotheses for developing safe and effective nutritional and therapeutic strategies for children with metabolic syndrome.
Keywords
Acknowledgments: The authors thank the Clinical Research Development Unit of Ghaem Hospital for their support.
Ethical Considerations: Written informed consent will be obtained from parents or guardians. The study procedures will be fully explained to eligible participants and their parents, and written consent will be obtained prior to enrollment. The trial is registered before participant enrollment. The study protocol was approved by the Ethics Committee of Mashhad University of Medical Sciences on May 20, 2023 (approval code: IR.MUMS.REC.1402.079). Official registration in the Iranian Registry of Clinical Trials (IRCT) was obtained on June 18, 2023 (registration number: IRCT20181022041407N4).
Conflict of interest: None declared.
Declaration of generative AI and AI-assisted technologies in the writing process: During the preparation of this manuscript, the authors used ChatGPT for English editing and to improve readability. The authors reviewed the entire manuscript, edited the content as necessary, and take full responsibility for the final published article.
Data Availability Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Funding Statement: This study will be supported by Mashhad University of Medical Sciences.
Consent for publication: Not applicable.
Author contributions: Conceptualization: AS; Investigation: SA, MA, SH; Writing-original draft: SA, ME, SM; Writing-review & editing: SA, ME, AS, SM
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/
