Medicinal Plant Research 2024, Vol.14, No.5, 285-296 http://hortherbpublisher.com/index.php/mpr 289 2021). Effective management of hyperglycemia is crucial to prevent these complications and improve the quality of life for patients with diabetes. The complications arising from hyperglycemia include diabetic retinopathy, nephropathy, neuropathy, and cardiovascular diseases. These complications are primarily due to the prolonged exposure of tissues to high glucose levels, which leads to the formation of advanced glycation end-products (AGEs) and subsequent oxidative stress and inflammation (Ghafouri et al., 2020). Therefore, controlling blood glucose levels is essential to mitigate these risks and prevent the progression of diabetes-related complications. 4.2 Research progress on the effects of Polygonatumextract on hyperglycemia in animal models Recent studies have demonstrated the potential of Polygonatum extracts in managing hyperglycemia in animal models. For instance, Polygonatum sibiricumsaponin (PSS) has shown significant hypoglycemic effects in type 2 diabetes mellitus (T2DM) mice by improving hepatic insulin resistance and promoting glycogen synthesis (Chen et al., 2022). PSS was found to decrease blood glucose levels, improve oral glucose tolerance, and enhance the activity of key proteins involved in glucose metabolism, such as AKT and GLUT-4. Another study investigated the effects of a novel polysaccharide from Polygonatum kingianum (PKPs-1) on hyperglycemia in STZ-induced diabetic mice. The results indicated that PKPs-1 significantly improved insulin tolerance and regulated glucose metabolism by activating the PI3K/AKT signaling pathway (Li et al., 2020). These findings suggest that Polygonatum extracts can effectively modulate glucose metabolism and improve insulin sensitivity, making them promising candidates for the development of functional beverages aimed at managing hyperglycemia. 4.3 Hypoglycemic effects of Polygonatumextract in cell models In vitro studies have also highlighted the hypoglycemic potential of Polygonatumextracts. For example, the Nine Steaming Nine Sun-drying processed Polygonatum kingianum (PK) water extracts exhibited substantial anti-hyperglycemic effects in cell models, such as HepG2 and Raw 264.7 cells (Zhou et al., 2023). The processed PK extracts were found to enhance the activity of key metabolic pathways, including the PI3K-Akt and MAPK pathways, which are crucial for glucose metabolism and insulin signaling. Additionally, the aqueous extract of Polygonatum sibiricum(PSAE) demonstrated protective effects on glucolipid metabolism in high-fat diet and streptozotocin-induced diabetic mice by activating the PI3K/AKT signaling pathway (Wang et al., 2022). These studies provide strong evidence for the hypoglycemic effects of Polygonatum extracts in cell models, supporting their potential use in functional beverages for hyperglycemia management. 5 Clinical Trial Design and Research Methods for PolygonatumFunctional Beverages 5.1 Clinical trial design The clinical trial for evaluating the efficacy of Polygonatumfunctional beverages in hyperglycemic patients will be designed as a randomized, double-blind, placebo-controlled study. Participants will be selected based on specific inclusion criteria, such as adults aged 18-65 years diagnosed with type 2 diabetes mellitus (T2DM) and having a fasting blood glucose level of ≥126 mg/dL. Exclusion criteria will include individuals with severe comorbid conditions, pregnant or lactating women, and those currently on insulin therapy or other investigational drugs. Participants will be randomly assigned into two groups: the intervention group receiving the Polygonatum functional beverage and the control group receiving a placebo beverage. The intervention will involve the daily consumption of the assigned beverage for a period of 12 weeks. The Polygonatumbeverage will be standardized to contain a specific concentration of active polysaccharides, while the placebo will be matched in taste and appearance but devoid of active ingredients (Shu et al., 2009; Li et al., 2017; Pinto et al., 2023).
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