Investigating chaga supplementation in type 2 diabetes: A novel prospective trial of metabolic, cognitive, and microbiome effects

Abstract

Type 2 diabetes mellitus (T2DM) manifests as chronic hyperglycaemia, insulin-resistance-driven neurocognitive decline, and gut microbiota perturbation. Preclinical studies show that polysaccharides, triterpenoids and polyphenols from Inonotus obliquus (Chaga) activate PI3K/Akt-GLUT4 translocation, phosphorylate AMPKα, enhance ubiquitin–proteasome throughput and remodel intestinal microbial networks—mechanisms predicted to restore metabolic homeostasis and proteostasis. On this basis, a double-blind, randomised, placebocontrolled trial in 200 adults (≥ 40 y) with T2DM will assess whether 12 weeks of 500 mg day-1 standardised Chaga extract adjunctive to usual care lowers glycated haemoglobin and improves HOMA-IR (primary endpoints), cognitive composite z-scores, microbial α/β-diversity and cardiometabolic biomarkers (secondary endpoints). Power analysis (85 %, α = 0.025) indicates sensitivity to a ≥ 0.5 % absolute HbA1c reduction using baseline-adjusted ANCOVA with complementary mixed models. Because dissertation-timeline constraints preclude immediate enrolment, trial registration and ethics submission remain forthcoming, consequently, this thesis provides a complete protocol, feasibility assessment and simulation-based power analysis, but no efficacy or safety data. By interrogating the metabolic–microbiome–brain axis, the planned study may show whether a fungal nutraceutical can concurrently attenuate insulin resistance, enhance cognition and promote eubiotic microbiota in T2DM, advancing precision nutrition and integrative diabetes care.