Zahedi Hoda, Hosseinzadeh-Attar Mohammad-Javad, Sahebkar Amirhossein, Ranjbar Shirin Hasani, Najafi Atabak, Hosseini Saeed, Qorbani Mostafa, Ahmadi Arezoo, Ardehali Seyed Hossein, Moravvej Hamideh, Pourmand Gholamreza, Norouzy Abdolreza, Shadnoush Mahdi
Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, No.44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran.
Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
J Diabetes Metab Disord. 2020 Sep 26;19(2):1609-1614. doi: 10.1007/s40200-019-00451-w. eCollection 2020 Dec.
Curcuminoids are dietary polyphenols that can improve health indices through different mechanisms such as anti-inflammatory, antioxidant and immunoregulatory properties. Due to the lack of evidences on the efficacy of curcuminoids in critically ill patients, this study was designed to investigate the effects of short-term curcuminoids supplementation on inflammatory, oxidative stress and adipokine indices as well as nutritional and clinical status in Traumatic Brain Injury (TBI) patients admitted in the Intensive Care Unit (ICU).
The present trial will be performed in the ICU of Sina and Shohadaye Tajrish hospitals of Tehran, Iran. Sixty-two critically ill patients with TBI will be enrolled based on the eligibility criteria. The patients will be randomly assigned into two groups. For 7 days, they will received either 500 mg curcuminoids in combination with 5 mg piperine or matched placebo. A general questionnaire, consent form as well as NUTRIC, SOFA and APACHEII scoring system and anthropometrics will be assessed at baseline. The inflammatory markers including TNF-α, IL-6, MCP-1 and CRP, oxidative stress indices (GPx and SOD) and adipokines (leptin and adiponetctin) will be measured at baseline and at the end of the study. In addition, dietary intake, concomitant drugs and laboratory tests will be recorded daily.
To the best of our knowledge, this is the first clinical trial investigating the effect of curcuminoids supplementation in critically ill patient with TBI. The findings of the present study will provide evidence on the efficacy and safety of curcuminoids in these patients.
(http://www.irct.ir, identifier: IRCT20180619040151N1), Registration date:18.09.2018.
姜黄素类化合物是膳食多酚，可通过抗炎、抗氧化和免疫调节等不同机制改善健康指标。由于缺乏关于姜黄素类化合物对重症患者疗效的证据，本研究旨在调查短期补充姜黄素类化合物对入住重症监护病房（ICU）的创伤性脑损伤（TBI）患者的炎症、氧化应激和脂肪因子指标以及营养和临床状况的影响。
本试验将在伊朗德黑兰的新浪医院和塔吉里什烈士医院的ICU进行。将根据纳入标准招募62例重症TBI患者。患者将被随机分为两组。连续7天，他们将接受500毫克姜黄素类化合物与5毫克胡椒碱的组合或匹配的安慰剂。在基线时评估一般问卷、知情同意书以及营养风险（NUTRIC）、序贯器官衰竭评估（SOFA）和急性生理与慢性健康状况评分系统II（APACHEII）以及人体测量学。在基线和研究结束时测量炎症标志物，包括肿瘤坏死因子-α（TNF-α）、白细胞介素-6（IL-6）、单核细胞趋化蛋白-1（MCP-1）和C反应蛋白（CRP）、氧化应激指标（谷胱甘肽过氧化物酶（GPx）和超氧化物歧化酶（SOD））和脂肪因子（瘦素和脂联素）。此外，每天记录饮食摄入量、伴随用药和实验室检查。
据我们所知，这是第一项研究补充姜黄素类化合物对重症TBI患者影响的临床试验。本研究的结果将为姜黄素类化合物在这些患者中的疗效和安全性提供证据。
（http://www.irct.ir，标识符：IRCT20180619040151N1），注册日期：2018年9月18日。
