A Novel Nutritional, Thirst-Free Drink Alleviates Type 2 Diabetes: From Toxicity Studies to Human Clinical Trials.

Abstract

Background: Although extracts from medicine food homologous plants have been widely used as interventions for the prevention and treatment of Type 2 diabetes mellitus (T2DM), it remains a major public health concern. Diabetes is also known as a "thirsting disorder" because it leads to the depletion of vital biomolecules in the body regardless of food or water intake and interferes with the replenishment of fluids through drinking. We developed a novel thirst-free drink (TF601) that contains a combination of traditional Chinese medicine food homologous plants extracts of Psidium guajava, Momordica charantia, Lycii Fructus, Glycyrrhizae Radix, and Camellia sinensis. In this study, we investigated TF601's drink subchronic toxicity evaluation in mice and an exploratory, uncontrolled clinical assessment of TF601 in patients with T2DM.

Methods: Herein, for toxicity studies, mice (male and female) were divided into a TF601-treated group and a control group. The TF601 drink was orally administered for 90 days to evaluate its toxicity. The mice were monitored daily for the appearance of any clinical signs. Their food intake and body weight changes were measured every week. Hematological, biochemical, and histopathological changes were also evaluated. For the exploratory human study, 14 patients with T2DM were enrolled in an uncontrolled pilot trial and glucose levels, hemoglobin A1c percentage, oral glucose tolerance levels, and body weight were monitored from baseline to 2 months later.

Results: Oral administration of TF601 drink in mice did not develop any clinical signs, nor did they die due to the treatment. No changes were noted in body weight, food intake, or liver, kidney, or brain histology. However, slightly significant changes were observed in the hematological and biochemical parameters only in male mice as compared with control mice. In the human clinical trial, significant improvements were noted in T2DM patients' glucose levels, and liver and kidney functions after a 2-month treatment with TF601. Overall, our toxicity studies in animals and clinical trials in humans revealed that TF601 drink was not toxic, alleviated the blood glucose level, and maintained body weight in T2DM patients.

Conclusion: These findings suggest that TF601 is well tolerated in a 90-day mouse toxicity study and may exhibit potential glucose-modulating effects in patients with T2DM. However, the human data are preliminary, and controlled clinical trials with larger sample sizes are required to confirm efficacy and safety.

Trial registration: Center for Traditional Medicine of Taipei Veterans General Hospital, IRB of Taipei Veterans General Hospital, Taipei, Taiwan (2021-08-011C), on August 18, 2021 retrospectively registered. https://vghtpe.cims.tw/wiPtms/index.html.