The effects of oral trehalose in patients with diabetes: a pilot randomized controlled trial
Somayyeh Hashemian, Mehrnaz Shojaei, Shabnam Radbakhsh, Sorour Ashari, Maryam Matbou Riahi, Zeinab Shateri Amiri, Stephen L. Atkin, Maciej Banach, Mohammad Bagherniya, Seyed Ahmad Emami, Amirhossein Sahebkar
Abstract
Introduction Trehalose 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 methods A 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. Results CRP 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). Conclusions 12 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.