The effects of oral trehalose in patients with diabetes: a pilot randomized controlled trial

Abstract

IntroductionTrehalose is a naturally occurring disaccharide of two glucose molecules that has been suggested as a potential therapeutic agent to reduce blood glucose and ameliorate diabetes-related complications in type 2 diabetes (T2D). This study aimed to determine the efficacy of medium-term trehalose treatment in patients with T2D.Material and methodsA double-blind, randomized, placebo-controlled trial in 40 patients with T2D was undertaken; 20 ingested trehalose 3.3 g/day and 20 placebo (sucrose) for three months. Parameters of glycemic indices, high-sensitivity C reactive protein (CRP), mood status and quality of life were measured.ResultsCRP was significantly less with trehalose treatment (-0.62±0.3, p=0.02); however, no differences in glycemic indices of fasting blood glucose (FBG) (-7.1±10.7, p=0.15), HbA1c (-0.1±0.4, p=0.73), insulin (0.73±0.8, p=0.39) or insulin resistance (HOMA-IR) (0.19±0.33, p=0.56) were seen between groups after 12 weeks. Depression and stress scores were lower with trehalose compared to placebo group (p=0.02 and p=0.05, respectively), whilst the quality-of-life score was higher with trehalose compared to placebo (p= 0.03) at the end of study. However, between-group differences in these indices did not reach statistical significance (-2.36±1.20, -2.21±1.39 and 3.00±1.76 for depression, stress and quality-of-life score, respectively) (p>0.05). The pro-oxidant antioxidant balance (PAB) did not differ between groups (-4.6 ±12.8, p=0.72).Conclusions12 weeks of treatment with 3.3 g /day of oral trehalose significantly improves CRP as a marker of inflammation though overall glycemic control was unaltered over this time frame.