The effect of Trehalose on inflammatory markers, oxidative stress, clinical symptoms, and mortality in patients with head trauma in Iran: a double-blind, placebo-controlled, randomized clinical trial protocol.

BACKGROUND: The occurrence of traumatic brain injury (TBI) has been progressively increasing over the years, mainly due to factors such as driving accidents and falls. Globally, TBI is now considered a significant cause of death and disability, particularly among young adults. TBI leads to inflammation and oxidative stress, significantly contributing to increased mortality and long-term complications. The importance of early therapeutic interventions in patients with TBI has been highlighted in several studies. The impact of trehalose as an anti-inflammatory and antioxidant on TBI has been well documented in animal models; however, this effect remains inconclusive in humans. This study aims to assess the effects of trehalose on inflammatory markers, oxidative stress, clinical outcomes, and mortality in TBI patients. METHOD: In this double-blind randomized controlled trial, we will recruit 80 patients aged 18 to 65 years with TBI from Al-Zahra Hospital, Isfahan, Iran, and randomly allocate them at the individual level into two groups of 40. One group will receive 10 g of trehalose daily (intervention group), while the other will receive 10 g of maltodextrin (placebo group) for 7 days. Primary outcomes include inflammatory markers (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin 6 (IL-6)), oxidative stress markers (total antioxidant capacity (TAC), superoxide dismutase (SOD), malondialdehyde (MDA)), clinical scores (sequential organ failure assessment (SOFA), Acute Physiology and Chronic Health Evaluation II (APACHE II), Nutrition Risk In Critically Ill (NUTRIC)), mortality (days 28, 60, 90), and hospital stay (day). DISCUSSION: Given the anti-inflammatory and antioxidant effects of trehalose observed in preclinical TBI models, its supplementation in patients with TBI may potentially improve the outcomes.