The effect of oral trehalose on inflammatory factors, oxidative stress, nutritional and clinical status in patients with head trauma at intensive care unit: A pilot, double-blind, controlled, randomized clinical trial

Background Traumatic brain injury (TBI) is the most common cause of cognitive and behavioral deficits, disability, and mortality worldwide. Trehalose is a natural non-reducing disaccharide of glucose which its anti-inflammatory and anti-oxidative stress effects have been proven in past in vivo and in vitro studies. This study aims to evaluate the effect of oral trehalose on inflammatory biomarkers, oxidative stress indices and clinical outcomes in hospitalized traumatic brain injury patients. Methods Twenty participants with traumatic brain injury were randomly assigned to the intervention or control group in order to evaluate the effect of oral trehalose (30g instead as a part of the daily carbohydrate of enteral feeding) or placebo groups (standard isocaloric hospital enteral feeding) using 12-day parallel study. Inflammatory and oxidative stress biomarkers such as interleukin-6 (IL-6), C-reactive protein (CRP), pro-oxidant-antioxidant balance (PAB), superoxide dismutase (SOD), glutathione (GSH), and malondialdehyde (MDA), clinical outcomes, including APACHE II, SOFA scores, NUTRIC score, GCS, ICU discharge time, mechanical ventilator duration, 28-day and 60-day mortality rate were measured at the beginning and end of the study. Results The trehalose intake could significantly improve CRP (mean change: −30±25mg/l, P˂0.001) and NUTRIC score (mean change: 0(−2,0), P=0.04). In addition, a marginally significant decrease in APACHE II score (mean change: −3±5, P=0.07) and 28-day mortality (0 vs. 30%; P=0.06, {NNT}=3) was observed. Moreover, among anthropometric indicators, only a marginally decrease in MAC (mean change: −0.5(−1,0) was shown. No considerable effect was observed on other biomarkers, anthropometric indices and clinical outcomes in the intervention group as well as the control group. Conclusion This trial provided some evidences that trehalose administration improved CRP and marginally improved some clinical outcomes, such as NUTRIC score and 28-day mortality in TBI patients in ICU.