- 學位論文
葡萄籽翠取物Naven-5對高尿酸病人之糖尿病相關生化值影響
The effects of the grape seed extract Naven-5 on diabetes related parameters in patient with hyperuricemia
摘要
自1990年代初期至今，保健食品的風潮就從未停歇。其中的葡萄籽萃取物具有極佳的抗氧化能力，目前尚無任何嚴重副作用的報告，也是抗氧化物質的首選，甚至是抗氧化的代名詞。 如今，糖尿病是全球普遍的一種代謝性疾病，而本研究探討的是，服用葡萄籽萃取物 (Naven-5) 並透過監控受試者的血液檢驗數據，來證明葡萄籽萃取物是否可改善糖尿病患者高血糖及發炎的情況。 本研究使用葡萄籽萃取物作為試驗材料，經修改配方並委託HACCP / ISO22000合格製造廠製成新的萃取物Naven-5。自獲得高雄國軍總醫院人體試驗委員會同意至本研究結束共一年時間。相關慢性病患皆可被收錄為受試者，包括高尿酸血症、糖尿病…等。受試模式設定為每日服用試驗材料，試驗期間受試者應維持原有藥物服用之模式，本研究檢測相關血液檢驗值。 本試驗收錄之病患共達１００位，其中２３位於試驗中退出，４６位為高血糖患者。糖化血色素的試驗結果並無顯著的統計差異，但卻具有極明確的正向趨勢。飯前血糖的試驗結果有著顯著降低的統計差異P < 0.0008，此結果顯示服用Naven-5對於改善糖尿病患者飯前血糖值是有積極及顯著的意義。 經由本研究的人體臨床試驗成果，可瞭解到使用Naven-5來作為保健食品及臨床試驗材料，是相當適當且無安全上的顧慮。總體來說，雖然本研究結果並非盡如人意，但的確可有效降低飯前血糖值，足以作為臨床上非常重要的參考基礎。
並列摘要
Background Since the 1990s, the craze for finding the healthiest foods has been in full swing. Grape extract has excellent antioxidant and it has become the symbol of a healthy diet, properties no serious side effects have been reported to date. Hyperglycemia is a common metabolic disease all over the world. This study investigates the effects of grape extract Naven-5 in patients with high plasma glucose and signs of inflammation. We evaluated the effect of this study subjects through monitoring serum parameters. Materials and methods This study used grape extract as the material source and modified it into a new extract - “Naven-5”. Since gaining permission from the IRB (Kaohsiung Armed Forces General Hospital), the clinical trial for the target extract has been finished. All patients who had chronic disease, such as hyperuricemia and hyperglycemia, were enrolled in the study. Oral dosage was setup and provided for those patients daily. The enrolled patients could keep their routine medication during the period of observation, and the laboratory data were obtained from the beginning to the end of this study. Results 100 hospitalized patients are enrolled, in this study 23 subjects drop out between this trial, 46 subjects are hyperglycemia. The HbA1c final result has no statistically significant meaning, but it has a positive trend. The FPG final result P < 0.0008 has statistically significant meaning, showed us Naven-5 indeed can prevent FPG increased. Conclusions The results show the Naven-5 is safety health food, and also can improve FPG and related parameters value. This result may not be very good, but it is clinically important as a reference basis. Keywords Grape seed extract, Anti-oxidation, Diabetes Mellitus (DM), Inflammation, Glucose Ante Cibum (AC), Haemoglobin A1c (HbA1c, A1c), Naven-5.