A Clinical Study on the Insulin Resistance Improvement Effects of Electrolyzed Hydrogen Rich Water in Type 2 Diabetes Patients: A Multicenter Prospective Double-Blind Randomized Control Trial

Abstract

Background: Electrolyzed hydrogen rich water (EHW) is known to possess reactive oxygen species suppressive effects. However, its influence on diabetes is still unclear. The aim of this study is to identify the influence of EHW on diabetes. Methods: In a multicenter, prospective, double-blind, randomized controlled trial, 50 patients with type 2 diabetes were assigned to EHW or filtered water (FW) groups. Changes in insulin resistance evaluated by HOMA-IR were set as the primary endpoint and oxidative stress markers and other clinical data were evaluated. Findings: The delta change in HOMA-IR was +0.04 (95% CI: -0.48 to 0.59, p = 0.850) in the FW group and -0.27 (95% CI: -0.69 to 0.09, p = 0.105) in the EHW group, and no significant change was observed between two groups (p = 0.282). However, EHW ingestion significantly improved insulin resistance in the subjects who had higher insulin resistance (HOMA-IR > 1.73) at baseline period. Oxidative stress marker was also significantly improved by EHW ingestion only in subjects who had higher value at the baseline period. The suppression of marker for reactive oxygen species correlated strongly with suppression of serum lactate. No adverse effect was observed by EHW treatment. Interpretation: Drinking EHW improved insulin resistance and redox status only in patients with deteriorated parameters. This effect seemed to be through a reduced gluconeogenesis. Even if normal subjects drink electrolyzed hydrogen water, it did not appear to manifest reactive oxygen species suppressive actions or insulin resistance improvement effects beyond desirable ranges. Trial Registration Number: This trial was registered with University Hospital Medical Information Network (UMI19032). Funding: Nihon-Trim Co. Ltd. Declaration of Interest: YO and SK are employees of Nihon Trim Co., Ltd. (Osaka, Japan). Authors declare there is no other conflict of interest. Ethical Approval: This study complied with the Helsinki Declaration and was conducted with the approval of the each Medical Ethics Committee of Tohoku University, Tohoku central hospital and Iwate Prefectural Takata Hospital. All participants provided their full informed consent.