Therapeutic effects of supplementation with Curcuminoids in critically ill patients receiving enteral nutrition: a randomized controlled trial protocol

Abstract

Background: 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). Methods: 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. Discussion: 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. Trial registration number: (http://www.irct.ir, identifier: IRCT20180619040151N1), Registration date:18.09.2018.