Medicinal Plant Research 2024, Vol.14, No.5, 285-296 http://hortherbpublisher.com/index.php/mpr 290 5.2 Evaluation indicators and measurement methods used in the study The primary evaluation indicator will be the change in fasting blood glucose levels from baseline to the end of the study. Secondary indicators will include HbA1c levels, insulin resistance measured by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and postprandial glucose levels. Blood samples will be collected at baseline, mid-point (6 weeks), and at the end of the study (12 weeks) to measure these parameters. Additional measurements will include lipid profiles (total cholesterol, LDL, HDL, and triglycerides), body weight, and body mass index (BMI). Insulin levels will be measured using a radioimmunoassay kit, and glucose levels will be determined using a standard glucose meter. The study will also assess oxidative stress markers and inflammatory cytokines to evaluate the broader metabolic effects of the Polygonatum beverage (Johnson et al., 2016; Gamboa-Gómez et al., 2017; Zarvandi et al., 2017). 5.3 Data collection and statistical analysis methods Data collection will involve regular monitoring and recording of participants' blood glucose levels, insulin levels, and other metabolic parameters at specified intervals. Participants will be required to maintain a daily log of their dietary intake and physical activity to control for external variables that may affect the study outcomes. Statistical analysis will be performed using repeated-measures ANOVA to compare the changes in primary and secondary outcomes between the intervention and control groups over time. The significance level will be set at p<0.05. Additionally, subgroup analyses will be conducted to explore the effects of the intervention on different demographic groups, such as age and gender. Data will be analyzed using statistical software such as SPSS or SAS (Loader et al., 2017; Thondre et al., 2021; Korytkowski et al., 2022). 6 Clinical Trial Results and Effectiveness Evaluation 6.1 Impact of Polygonatumfunctional beverages on blood glucose levels in hyperglycemic patients Clinical trials have demonstrated that Polygonatumextracts, particularly Polygonatum sibiricum saponin (PSS), exhibit significant hypoglycemic effects. In studies involving type 2 diabetes mellitus (T2DM) mice, PSS was shown to significantly decrease fasting blood glucose (FBG) levels and insulin secretion (Chai et al., 2021; Chen et al., 2022). Additionally, the aqueous extract of Polygonatum sibiricum(PSAE) was found to ameliorate glucose metabolism by reducing fasting blood glucose and hemoglobin A1c levels in high-fat diet and streptozotocin-induced diabetic mice (Wang et al., 2022). These findings suggest that functional beverages containing Polygonatumextracts could effectively lower blood glucose levels in hyperglycemic patients. The hypoglycemic activity of a novel polysaccharide fromPolygonatum kingianum(PKPs-1) was investigated in STZ-induced diabetic mice. The results indicated that PKPs-1 significantly improved insulin tolerance and reduced blood glucose levels by activating the PI3K/AKT signaling pathway (Li et al., 2021). This further supports the potential of Polygonatum-based functional beverages in managing hyperglycemia. 6.2 Effects on other health indicators In addition to their hypoglycemic effects, Polygonatum extracts have been shown to positively influence other health indicators. For instance, PSS significantly reduced the levels of total triglyceride (TG), total cholesterol (TCHO), and low-density lipoprotein cholesterol (LDL-C) while increasing high-density lipoprotein cholesterol (HDL-C) in T2DM mice (Chai et al., 2021; Chen et al., 2022). Similarly, PSAE improved lipid metabolism by lowering serum total cholesterol, triglyceride, and liver triglyceride levels in diabetic mice (Wang et al., 2022). Polygonatum extracts have demonstrated potential in managing body weight and inflammatory markers. The alcohol-free fermented blueberry-blackberry beverage containing phenolic compounds, which shares some functional similarities with Polygonatumextracts, was found to attenuate diet-induced obesity and reduce fasting blood glucose in mice (Jokura et al., 2015). Additionally, PSS was shown to alleviate hepatic insulin resistance and repair islet beta cells, thereby reducing inflammation and improving overall metabolic health (Figure 2) (Chen et al., 2022).
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