The effects of oral trehalose on glycaemia, inflammation, and quality of life in patients with type 2 diabetes: a pilot randomized controlled trial.

"Conflict of interest The authors declare no conflict of interest."

"We are thankful for the financial support from the National Institute for Medical Research Development (NIMAD), Tehran, Iran (Grant No. 996398). This is the first randomized dietary intervention trial to assess the anti-hyperglycaemic effects of trehalose in patients with type 2 diabetes. It showed that trehalose decreases CRP as a mediator of inflammation and that there was an indication of overall quality of life being improved by trehalose supplementation. Whilst fasting blood glucose, insulin, insulin resistance, and HbA1c did not differ over the 12-week period, the change in CRP may, over a longer period, affect glycaemic control and potentially diabetes-related complications. Studies have shown that trehalose can modulate glucose metabolism and insulin sensitivity in healthy subjects [–]. Previous research has shown that 12-week trehalose ingestion improved glucose tolerance in subjects with BMI ≥ 23 kg/m2 and with a high risk for type 2 diabetes. Trehalose markedly reduced blood glucose after a 2-h OGTT following 3 months of intake in comparison with baseline compared to a sucrose group []. This suggests that one mode of action of trehalose would be to modulate the absorption of sugars to give a flat absorption process, thus avoiding marked glucose excursions; hence, while mean glycaemic control may not be affected, glucose variability may be reduced and needs further investigation. These studies have been supported by animal work showing that the administration of trehalose could effectively ameliorate the increased FBG levels, glucose intolerance, and insulin response in streptozotocin-induced diabetic rats []."

"Trial registration: IRCT20130829014521N18. Forty participants aged 35–85 years with T2D, who were referred to the endocrinology and metabolism clinic from January to May 2022 were selected for enrolment in the present study, which was designed as a parallel, double-blind, randomized, placebo-controlled clinical trial. The protocol was registered at the Iranian Registry of Clinical Trials with the number IRCT20130829014521N18 (https://en.irct.ir/trial/54391) and approved by the Institutional Ethics Committee and Research Advisory Committee of the National Institute for Medical Research Development (IR.NIMAD.REC.1399.267). All participants provided written informed consent. Inclusion criteria: fasting blood glucose ≥ 126 mg/dl and T2D with no change in medication over the preceding 3 months. Exclusion criteria: type 1 diabetes, insulin therapy, renal dysfunction (eGFR less than 30 ml/min), severe liver dysfunction or cirrhosis, usage of α-glucosidase inhibitors such as acarbose, oral or injectable corticosteroids usage, pregnancy, lactation or nursing, or wishing to conceive. If any individual was unwilling to continue the trial or had poor compliance with the trial treatment (< 80%), he/she was withdrawn from the study during the follow-up period."