CN1278181A - 治疗糖尿病、高血糖和低血糖的方法 - Google Patents
治疗糖尿病、高血糖和低血糖的方法 Download PDFInfo
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- CN1278181A CN1278181A CN98810675A CN98810675A CN1278181A CN 1278181 A CN1278181 A CN 1278181A CN 98810675 A CN98810675 A CN 98810675A CN 98810675 A CN98810675 A CN 98810675A CN 1278181 A CN1278181 A CN 1278181A
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Abstract
本发明公开了控制哺乳动物血清葡萄糖水平的方法,包括:摄入稳定的米糠衍生物,具体为可溶性部分、不溶性部分、酶处理的稳定的米糠或其混合物。这些方法可用于控制糖尿病和高血糖。本发明也公开了包含稳定的米糠衍生物、非稻米消费品及摄食说明书的糖尿病食盒。
Description
相关的申请
本申请与1997年8月29日提交的美国专利申请No.60/057.409相关,该申请的内容在此引为参考。
发明的领域
本发明涉及控制哺乳动物血清葡萄糖水平的方法。
发明的背景
糖尿病是一种无法治愈的慢性疾病。它影响着一千六百万美国人和一亿二千五百多万世界各国人。糖尿病在美国是第四大疾病死亡的原因。1997年,178,000人死于此病及其相关的并发症。
糖尿病的特征是代谢碳水化合物的能力受损、血中葡萄糖升高和尿中排泄葡萄糖。这一缺陷涉及胰岛素促进细胞摄取葡萄糖、以ATP的形式释放能量的作用受干扰。
糖尿病患者胰脏产生胰岛素不足或不产生胰岛素,这种激素负责细胞吸收葡萄糖以满足能量需求。结果,血中葡萄糖水平变得异常高,引起多尿和经常口渴、饥饿。机体不能储存或利用葡萄糖,引起体重减轻和疲劳。糖尿病还导致脂类代谢紊乱和促使小血管变性。
有两大类糖尿病。I型是较严重的形式,通常首先见于35岁以下的人,最常见于10-16岁的人。它发展迅速。胰脏分泌胰岛素的细胞受损,可能是一种病毒感染后免疫反应的结果,胰岛素的产生几乎完全停止。患者在缺乏规则注射胰岛素的情况下转入昏迷和死亡。I型糖尿病起因于胰岛β细胞不能分泌胰岛素的病理变化。它可能是由于遗传素因或病毒感染,其中β细胞受抑制,不能分泌胰岛素。罹患I型糖尿病的患者是完全胰岛素依赖性的,一般在约25岁时被证实。
最普通的糖尿病类型,II型糖尿病,通常是逐渐发病的,主要见于40岁以上的人。很多病例仅仅是在常规医学检查时发现的。II型糖尿病患者有此种病状是由于葡萄糖吸收障碍或外周胰岛素利用受损的病理因素或由于与葡萄糖/胰岛素的吸收/利用有关的红细胞受体异常(部分是遗传的)的结果。特别是当人体重超重时,没有足够的胰岛素产生以满足机体的需要。当受体失活时,机体常对胰岛素的效应产生抵抗。在大多数病例,开始时不需要作胰岛素替代注射。饮食控制、减轻体重和口服药物相结合,可将病情控制一段时间,但是大多数II型糖尿病患者最终需要注射胰岛素。
I型和II型糖尿病的并发症之一是异常糖基化(glycated)化合物的产生。在未加以控制的I型和II型糖尿病,常遇见糖基化和糖氧化(glycoxidation)作用,一个连续的过程。这涉及与动脉粥样硬化有关的低密度脂蛋白(LDL)表面蛋白及其组份载脂蛋白B。糖基化和糖氧化产物有单核细胞趋化性。血管细胞中的单核细胞浸润巨噬细胞,在血管胶原中形成泡沫细胞,加速脂蛋白的粘附,抑制免疫复合物,导致动脉粥样斑块。血液中的赖氨酸果糖是治疗前后糖基化程度的指针。血清中的甲氧甲酰赖氨酸是治疗前后糖氧化程度的指针。
II型糖尿病患者氧化剂和抗氧化剂之间失平衡,导致内皮功能障碍,这种失平衡可使患者易于动脉粥样硬化和靶器官受损。脂类过氧化水平高,同时诸如超氧化物歧化酶、维生素E、谷胱甘肽过氧化物酶、甲硫氨酸还原酶和氧化一氮等抗氧化剂水平降低。
与非糖尿病相比,该疾病的长期并发症通常是预期寿命减少、神经病变和失明率提高(约25倍)、肾脏疾病发病率提高(约17倍)和心脏疾病发病率提高(约2倍)。I型和II型糖尿病常伴有高胆固醇血症和高脂血症。
如上所述,可用胰岛素、有时可通过饮食控制来控制糖尿病。但是,接受胰岛素或饮食治疗的患者血糖水平仍然会变波动(有时波动很大)。而且,在严重的糖尿病病例,患者必须持续监测血葡萄糖水平以防止相关的疾病。糖尿病患者被迫注射胰岛素,最终导致某些区域皮肉受损。此外,别的医学并发症常常起因于糖尿病,如动脉粥样硬化、高脂血症、视网膜受损、神经损害、疲劳和衰弱。
因此,有必要寻找副作用最小、无侵袭性过程(如注射)的安全有效的治疗糖尿病方法。而且,有必要寻找针对常伴随糖尿病出现的其它疾病的治疗方法,以保证患者处于可能的最佳健康状况。本发明满足了这些及其它需求。
发明的概述
在某些情况下,糖尿病的常规治疗是在监测血葡萄糖水平下每天注射一次或几次各种形式的胰岛素。即使并非不可能,但用常规的治疗方法难以获得接近正常的血糖水平。极需对糖尿病作附加治疗以控制血清葡萄糖水平。本发明者惊人地发现,摄入稳定的米糠衍生物能控制哺乳动物血清葡萄糖水平。这样,本发明一方面涉及通过摄入稳定的米糠衍生物(如酶处理的稳定的米糠,可溶性部分和不溶性部分及其混合物)降低哺乳动物血清葡萄糖水平的方法。在一个实施方案中,每天摄入米糠衍生物总量约为10克至约100克,以至少二次剂量为佳。
在另一个实施方案中,本发明涉及通过摄入稳定的米糠衍生物(如酶处理的稳定的米糠,可溶性部分和不溶性部分及其混合物)控制哺乳动物高血糖症的方法。
在另一个实施方案中,本发明涉及糖尿病食物补充盒,包括稳定的米糠衍生物(如酶处理的稳定的米糠、可溶性部分和不溶性部分及其混合物);非稻米消费品;及盒内成分的使用说明书。
参照下面的详细描述,其它实施方案对于本领域技术人员来说是不言自明的。
最佳实施方案的描述
I.术语表
本文所用的术语“载脂蛋白B”(″apolipoprotein B″或″apoprotein B″或″Apo B″)指胆固醇运输蛋白质的蛋白成分。再合成的胆固醇以脂蛋白的形式从肝和肠运输到外周组织。载脂蛋白B极大部分以极低密度脂蛋白(VLDL)分泌到循环系统。
本文所用的术语“动脉粥样硬化”是因泡沫细胞和主动脉条斑的形成而引起的动脉壁变性使动脉狭窄。它限制了血液循环,使机体易发生血栓形成。
本文所用的术语“酶处理的稳定的米糠衍生物”指用如下方法制备的酶处理的稳定的米糠:将稳定的米糠与约15%-35%水性浆状物(w/w)的水性溶液混合;加酶到该水性米糠浆状物中将淀粉转变为糊精,然后直接干燥糊精溶液,得到酶处理的稳定的米糠衍生物。酶处理的稳定的米糠衍生物包含约20%-约30%总食用纤维。
本文所用的术语“GRAS”表示关于食物添加剂一般认为是安全的。
本文所用的术语“高胆固醇血症”,如成人高胆固醇检测、治疗评价的国家胆固醇教育计划(NCEP)专家小组报告的方针所述(见Arch.Int.Med.(1988)148,36-39),是伴循环中总胆固醇、LDL-胆固醇和VLDL-胆固醇水平升高的状态。
本文所用的术语“高血糖症”指血流中葡萄糖过量。它可见于因血流中胰岛素不足和单纯的碳水化合物摄入过量引起的各种疾病。
本文所用的术语“低血糖症”指血流中葡萄糖缺乏。如果严重的话,可导致低血糖昏迷。
本文所用的术语“高脂血症”(hyperlipidemia或hyperlipemia)是血液中血脂参数升高的状态。该状态出现异常的高浓度脂肪。循环血液中的脂类是总胆固醇、低密度脂蛋白、极低密度脂蛋白和甘油三酯。
本文所用的术语“脂蛋白”,如极低密度脂蛋白(VLDL)、低密度脂蛋白(LDL)和高密度脂蛋白(HDL),指在血清、血浆和淋巴液中发现的一组蛋白质,它们对脂类转运具有重要性。各脂蛋白的化学组成不同,HDL的蛋白质/脂类比例高,而VLDL蛋白质/脂类比例较低。
本文所用的术语“稳定的米糠衍生物不溶性部分”指分离过程中的一部分。具体地说,稳定的米糠水性浆状物经酶处理后泵入卧式离心机,不溶性部分从水溶液中析出沉淀,收集不溶性部分,然后干燥,继而研成粉末,此粉末即不溶性部分。组成成分及其百分比列于表I和IV。
本文所用的术语“稳定的米糠衍生物可溶性部分”指分离过程中的一部分。具体地说,稳定的米糠水性浆状物经酶处理后泵入卧式离心机,不溶性部分从水溶液中析出沉淀,水性物质泵入干燥器干燥,干燥的水性部分产生可溶性部分。组成成分及其百分比列于表I和V。
本文所用的术语“甘油三酯”指甘油与三个脂肪酸分子组成的脂类或中性油脂。
II.详细描述
在收获的稻(也称作粗稻)中,仁完全被稻壳包裹。碾轧的过程除去稻壳,得到棕色的稻米。然后通过研磨过程除去外面的棕色层,得到白米。分离到的棕色层称作米糠。
米糠是中果皮,即通过碾轧或磨光棕色稻米得到的壳和米粒之间的部分。它占粗稻的约10%,它一般用作动物饲料,除了几种有效的微量元素外,含约18-24%脂肪、约25%食用纤维、约14%蛋白质和约45%总碳水化合物。除了几种有效的抗氧化剂外,它富含复合维生素B、维生素E及其异构体、钾和镁和磷等矿物质。
稳定的米糠有市售或可用各种方法制备。多数米糠稳定方法导致现存脂肪酶的失活、过氧化物酶的失活和微生物的失活,而米糠中仍保留高水平抗氧化剂。关于稳定化和处理的一般讨论见W.E.Marshall & James I Wadswoth编著的Rice Science and Technology(1994),第390-404页。
棕色稻米研磨成米时,在正常情况下,米糠中的油和米糠中的脂肪酶相互接触,导致米油迅速降解为游离脂肪酸和甘油。米糠变得味道差,不再适合于食用。然而,如果脂肪酶失活,米糠因而稳定,其对米糠的不良效应则可避免。
有很多合适的方法用于米糠中脂肪酶的稳定或失活,但是大多数商业系统利用加水或干燥挤压法。由于这些系统能量需求较低、资金花费少和操作容易,因而被选用。干燥挤压稳定化利用剪切、摩擦和压力以产生灭活脂肪酸所需要的热。米糠的温度必须达到最低130-140℃,达3秒钟,以确保脂肪酶失活。
通过加水或蒸汽可在不太严格的条件下达到可接受的挤压稳定化。在较高的湿度下脂肪酶对热更敏感,因此可在略低的挤压温度下灭活。
残余过氧化物酶活性通常用作确定稳定化米糠中脂肪酶活性已确被灭活的标准手段。过氧化物酶通常被认为比脂肪酶对热更稳定,过氧化物酶活性测定比脂肪酶的测定更容易和可靠。灭活过氧化物酶及脂肪酶所需处理条件也可引起米糠中抗氧化剂的改变或丧失。这可导致脂肪酸较低,但米糠可受到氧化而腐败恶臭。此外,由于米糠对霉菌、酵母和细菌敏感,因此稳定化处理必须有效地降低米糠的微生物含量。
除了加水分和用于稳定化的挤压技术外,米糠的冷冻和冷藏产生经济上可行的稳定米糠的方法。用于稳定米糠的方法最好能使脂肪酸含量最低,而保持高水平抗氧化剂。食物级稳定的米糠典型地是细颗粒、浅棕黄色的,具有相当柔和的坚果味、烤过的色彩。
稳定的米糠可购自Producers Rice Mill Inc.(阿肯色州斯图加特)、Riceland Foods(阿肯色州斯图加特)、Riviana Foods,Inc.(得克萨斯州休斯顿)、Uncle Ben’s Inc.(得克萨斯州休斯顿)和The RiceX Company(加利福尼亚州E1 Dorado Hills)。由于稳定方法不同,从不同的制造商得到的稳定的米糠在组成和稳定特性上会有所不同。
为了使米糠衍生物用于本发明,首先将米糠稳定化,然后再分离成至少两部分,它们包括(但不限于)稳定的米糠可溶性衍生物和稳定的米糠不溶性衍生物。分离成米糠衍生物的方法以包括非化学方法即酶学方法为佳。在此方法中,分离或分筛最好按下文概述的进行。
用饮用水将稳定的米糠制成约15%-约35%的浆状物,较佳为20-25%浆状物。加酶到配料量中将淀粉转化为糊精,所述酶可包括(但不限于)葡聚糖酶、麦芽糖酶、α-淀粉酶和各种其它碳水化合物裂解酶。用蒸汽注入蒸煮器、热交换器或其它加热方法,将浆状物加热到约150-约200°F。然后将浆状物泵入卧式离心机,在此分离出不溶性部分。收集不溶性部分,在带式干燥器上干燥,接着磨成粉末。此粉末即稳定的米糠不溶性部分。将水性物质泵入转鼓式干燥机进行干燥。此干燥的水性部分产生稳定的米糠可溶性部分。
如上所述,用米糠浆状物可产生酶处理的稳定的米糠。这样,另一方面本发明涉及酶处理的稳定的米糠衍生物的制备方法,包括:将稳定的米糠与水溶液混合,形成约15%-约35%的水性米糠浆状物,较佳为约20%-约30%水性米糠浆状物(w/w);加酶到此水性米糠浆状物中将淀粉转化为糊精,从而形成酶处理的浆状物,然后直接干燥酶处理的浆状物,形成酶处理的稳定的米糠衍生物。
在上述方法的一个优选实施方案中,在将酶加到浆状物中后,将浆状物加热到约100-约200°F,较佳为将浆状物加热到约150-约200°F。然后将浆状物干燥,干燥采用诸如带式干燥、喷雾干燥、转鼓式干燥和空气干燥等方法进行,以转鼓式干燥为佳。
这些稳定的米糠衍生物也可购自加利福尼亚的RiceX公司。为了本发明的目的,购得的稳定的米糠是RiceXTM稳定的米糠。从加利福尼亚E1 DoradoHills的RiceX公司购得的不溶性衍生物是RiceXTM纤维复合物,购得的可溶性衍生物是RiceX RicelinTM。
稳定的米糠衍生物可取各种形式。它们可以是粉末、食物、食物添加剂、药膳、液体、饮料、乳剂或其混合物。此外,它们可掺入其它食用材料中。为了将米糠衍生物掺入哺乳动物的饮食中,各种供选择的方法包括(但不限于)简单地将该衍生物撒布在作为多种谷类即食食品(multigrain ready to eatcereal)主要成分的另一种食用物质(即沙拉、面包、谷类食物等)上;将其掺入烘焙产物(面包、脆皮松饼、华夫饼干等)、面制食品、保健点心和快餐(运动员排、保健饮料等)和高纤维食物中。
稳定的米糠包含约18-23%脂肪、约23-35%膳食纤维、约12-16%蛋白质、约8-36%总碳水化合物和很多有效的微量成分。米糠可溶性部分含有约15-40%脂肪(较佳为23-30%脂肪);约0-25%膳食纤维(较佳为约0-20%膳食纤维);约0-15%蛋白质(较佳为6-9%蛋白质)和约25-80%碳水化合物(较佳为约27-66%简单碳水化合物),是水溶性部分。稳定的米糠不溶性衍生物包含约5-20%脂肪(较佳为11-16%脂肪);约40-65%膳食纤维(较佳为40-60%膳食纤维)和约10-30%蛋白质(较佳为18-22%蛋白质)(见表I)。
表I组成(est.)
RiceXTM稳定的米糠 | |
脂肪 | 18-23% |
蛋白质 | 12-16% |
总膳食纤维 | 23-35% |
可溶性纤维 | 2-6% |
碳水化合物 | 8-36% |
灰分 | 7-10% |
水分 | 4-8 |
表I(续)
RiceX RicelinTM | |
脂肪 | 23-30% |
蛋白质 | 6-9% |
总膳食纤维 | 0-20% |
碳水化合物 | 27-66% |
灰分 | 3-7% |
水分 | 2-7% |
表I(续)
RiceXTM纤维复合物 | |
脂肪 | 11-16% |
蛋白质 | 18-22% |
总膳食纤维 | 40-60% |
可溶性纤维 | 0-12% |
碳水化合物 | 0-12% |
灰分 | 8-12% |
水分 | 1-6% |
关于实施例4中的表IV、V、VI和VII,显示这些衍生物至少有75个有效的抗氧化剂。主要的抗氧化剂维生素E及其异构体(称作生育酚(T)和生育三烯酚(T3))总称为母育酚。富含母育酚的物质是含有选自生育酚(T)、生育三烯酚(T3)和生育三烯酚样(T3样)化合物中一种或多种化合物的混合物。
稳定的米糠衍生物中的抗氧化剂包括(但不限于)γ-谷维素、β-胡萝卜素、几种已知的黄酮类化合物、植物甾醇、硫辛酸和阿魏酸。这些化合物中有几种的浓度很高,比任何天然来源的均高。据信,抗氧化剂(特别是母育酚类化合物),如下面所讨论的那样单独或协同使用,在明显纠正某些代谢障碍上起着至关重要的作用。
稳定的米糠可溶性衍生物是可溶性稳定的米糠和胚芽的粉状乳剂,容易消化和被机体吸收。它可与少量水同服,在口中溶解。它也可混入液体如果汁或热饮料中。此外,它适用于上面讨论的烘焙制品和其它食品。有为数众多的营养物质在米糠可溶物(稳定的米糠可溶性衍生物)中被发现。
稳定的米糠不溶性衍生物结合胆酸,降低血清胆固醇水平和甘油三酯水平,从而有助于胆固醇代谢。它主要包含许多高强度抗氧化剂,如β-胡萝卜素、α、β、γ和δ生育酚和生育三烯酚、植酸盐、谷维素、糖苷和各种植物甾醇和多元酚。米糠不溶性衍生物也可混入液体如果汁或热饮料中。此外,如上面所讨论的,它适合用于烘焙制品和其它食品。
酶处理的稳定的米糠衍生物还可混合在液体如果汁或热饮料中。此外,如上面所讨论的,它适合用于烘焙制品和其它食品。
另一方面,本发明涉及控制哺乳动物血清葡萄糖水平的方法,包括摄入稳定的米糠衍生物,如酶处理的稳定的米糠,可溶性部分、不溶性部分或其混合物。哺乳动物以人类个体为佳。在一个优选实施例中,由于糖尿病症如I型和II型糖尿病而葡萄糖水平升高。每天共摄入总量约10克至约100克的米糠衍生物,较佳为至少2次剂量。较佳的为每天共摄入总量约10克至约40克的米糠衍生物,更佳的为每天共摄入总量约15克至约30克。
目前较佳的是口服稳定的米糠衍生物。最适剂量由医生根据患者年龄、体重和一般健康状况来决定。如上面所讨论的,每天剂量还可用持续一段时间的一次或几次给药的方式摄入,例如每天通过一次或多次剂量或从缓释组合物中释放。
本发明基于如下发现:罹患I型和II型糖尿病的患者摄入含米糠衍生物的产物,这种产物是得自米糠的任何物质,包括(但不限于)酶处理的稳定的米糠、米糠可溶物和米糠不溶物,患者明显地降低血清葡萄糖水平,从而控制血葡萄糖水平。
另一方面,本发明涉及控制哺乳动物高血糖的方法。该方法包括摄入稳定的米糠衍生物,如酶处理的稳定的米糠、可溶性部分和不溶性部分及其混合物。米糠衍生物可单独或更经常的是以含治疗有效量的活性剂与惰性GRAS结合的食品形式给予。
在还有一个方面,本发明涉及糖尿病食物补充盒。该盒包含稳定的米糠衍生物,如酶处理的稳定的米糠、可溶性部分和不溶性部分及其混合物;非稻米消费品;及摄入衍生物的说明书。非稻米消费品可以是稳定的米糠衍生物的载体。此外,该盒还包含使用说明书。
非稻米消费品可以是将米糠衍生物掺入哺乳动物饮食的很多方法之一。它们包括(但不限于)简单地将该衍生物撒布在作为多种谷类即食食品(multigrain ready to eat cereal)主要成分的另一种食用物质(即沙拉、面包、谷类食物等)上;将其掺入烘焙产物(面包、脆皮松饼、华夫饼干等)、面制食品、保健点心和快餐(运动员排、保健饮料等)和高纤维食物中。非稻米消费品也可是包含(但不限于)载体和赋形剂的各种食物配方。米糠衍生物还可与包括抗生素或抗病毒剂在内的其它治疗剂合用。
高血糖糖尿病症相关疾病的控制
稳定的米糠衍生物是极有效的降血糖剂,因此作为营养补充剂有助于糖尿病症(I型和II型)、高血糖和相关状态的控制。这些生物效应是由于在稳定的米糠衍生物中存在的多种生物活性成分的协同效应所致(见表IV-VII)。这种影响葡萄糖维持的机制显示其不同于影响葡萄糖吸收、利用和排泌的效应。不受特定任何理论的束缚,据信,稳定的米糠衍生物中各生物活性成分的作用机制包括(但不限于)以下几种:
1.B族维生素的作用;
a.烟酸大量存在于稳定的米糠衍生物中。烟酸通过胰脏β-细胞中烟酰胺腺嘌啉二核苷酸(辅酶I)的利用而与细胞内能量供应有关,从而影响血葡萄糖水平。
b.吡多醇是预防糖尿病神经病变的必不可少的要素成分。
c.硫胺素和生物素是葡萄糖控制中极重要的代谢因子。
d.因此,稳定的米糠衍生物中的B族维生素在全身水平改善葡萄糖吸收和/或改善葡萄糖的外周利用,从而有助于餐后血糖的控制。
2.肌醇在胰岛素胞吐作用的调控上具有调节作用,因此有助于胰岛素分泌过程。
3.存在于稳定的米糠衍生物中的非淀粉多糖和ligins提高免疫复合物、激活红细胞上的胰岛素受体,从而促进外周葡萄糖的利用。
4.稳定的米糠衍生物富含半纤维素,它提高外周血中的淋巴细胞,从而降低糖尿病的神经病学的并发症。
5.存在于稳定的米糠衍生物中的诸如生育酚、生育三烯酚类、γ-谷维素、多元酚类(特别是阿魏酸和硫辛酸)之类抗氧化剂和其它微量抗氧化剂是自由基清除剂,可改善糖尿病并发症,如动脉硬化、高血脂、视网膜病、非酶促糖基化、糖氧化(glycoxidation)、肾脏损害和神经病变。γ-谷维素改善毛细血管血液循环,并具有神经调节效应。
6.存在于稳定的米糠衍生物的可溶性部分的非淀粉多糖在肠内形成胶束,后者可有利于葡萄糖的缓慢吸收和释放到循环中,从而帮助维持餐后葡萄糖水平。
7.稳定的米糠衍生物的蛋白质、纤维和脂肪也帮助控制高血糖和相关状态,这些是糖尿病患者重要的保健管理问题。
III.实施例
实施例1
本实施例阐述稳定的米糠衍生物在糖尿病患者上的临床评估。而且,评估了RiceX稳定的米糠、RiceX Ricelin(稳定的米糠可溶性衍生物)和RiceX纤维复合物(稳定的米糠不溶性衍生物)对糖尿病病人(I型)和非胰岛素依赖性糖尿病(II型)人类受治疗者血液葡萄糖和脂类的效应。这一临床评估在威斯康辛州麦迪逊的高级医学研究中心和巴基斯坦拉瓦尔品第军队病理研究所进行。
材料和方法
A.产物描述
RiceX稳定的米糠、RiceX Ricelin和RiceX纤维复合物是富含纤维,非淀粉多糖、复合碳水化合物、蛋白质、脂肪、B族复合维生素和强抗氧化剂,如β-胡萝卜素、维生素E(生育酚和生育三烯酚)、γ-谷维素、植物甾醇和多元酚。
B.产物编码
产物A:RiceX稳定的米糠
产物B:RiceX Ricelin
产物C:RiceX纤维复合物
C.受治疗者
所选的受治疗者是经临床确证的糖尿病(I型或II型)病例,男性或女性,年龄在20-65岁之间,理想的体重(+20%),未诊断有并发症。用口服降糖药或胰岛素治疗或两者兼用,对受治疗者进行血糖控制。所有受治疗者接受国家胆固醇教育计划(NCEP)第一步饮食。
D.剂量和疗程
先筛选受治疗者并随机分配到RiceX产物治疗方案中。给每一受治疗者分开提供两次同样剂量试验产品,每次10克,一次在早餐前,一次在正餐前,用牛奶/果汁/水饮料送服。每个受治疗者每天总剂量20克,共8周。
E.研究方案
相继或分别随机给予产物8周。当受治疗者作一种以上产物的评价时,在转到下一种产物前有4周清除阶段,用纤维素安慰剂替代治疗。在每个产物治疗方案前采起始空腹血样,在每个产物治疗方案末采最终空腹血样、这些血样用于测量血糖和脂类参数。对每个受治疗者进行物理参数的测量和记录,如体重、体重指数(body mass index)、高度、药物治疗和饮食。每天早上早餐前和每天傍晚正常前,对受治疗者采毛细血管血,用糖量计监测血液葡萄糖水平。如研究医生所推荐的,通过减少药物和受治疗者维持量米糠产物来控制任何明显的变化,如突然低血糖发作。
F.生化分析
所有受治疗者在每种产物治疗前和治疗后随机起始和最终血样,储存于-80℃直至分析。对这些血样作糖基化血红蛋白、葡萄糖、胰岛素、总胆固醇、低密度脂蛋白-胆固醇、高密度脂蛋白-胆固醇、载脂蛋白B和甘油三酯分析。所用的所有方法都是AOAC批准的方法。
G.数据的统计分析
按照方差分析(Yanagava等,Biometrics,40:301-311,1984),用从基线值(0时间)至研究结束时的变化对所有参数作统计分析。比较三种产物之间的这些数据。
结果
表II总结了I型受治疗者血糖和血脂参数的研究,而表III提供II型受治疗者的数据。
H.I型研究
如上所述,将总数45个临床确证为I型糖尿病的受治疗者随机用RiceX米糠产物作相继或单独治疗。共22个受治疗者用产物A、26个用产物B、20个用产物C进行治疗。三个产物血糖和脂类参数的合并平均值见表II。
I.II型研究
如研究方案中所述,将总数41个临床确证为II型糖尿病的受治疗者随机用RiceX米糠产物作单独或相继治疗。共23个受治疗者用产物A、31个用产物B、26个用产物C进行治疗。三个产物血糖和脂类参数的合并平均值见表III。
J.血糖控制
结果表明,在糖基化血红蛋白上有统计学意义上的显著(p=0.05)降低,对I型受治疗者8周使用RiceX Ricelin时为11%,使用RiceX纤维复合物时为10%。在II型受治疗者的糖基化血红蛋白上显示类似的统计学意义上的显著(p=0.05)降低。RiceX Ricelin消耗8周导致糖基化血红蛋白降低10%,而RiceX纤维复合物消耗8周导致降低1 1%。与起始值相比,I型和II型受治疗者消耗8周RiceX Ricelin后,空腹血清葡萄糖均显示统计学意义上的(p<0.5)显著降低33%。与起始值相比,RiceX纤维复合物对I型和II型也显示静脉血分析中空腹葡萄糖水平分别降低19%和22%。
消耗8周RiceX Ricelin的I型受治疗者空腹葡萄糖和餐前半小时测得的葡萄糖(用糖量计检测)分别降低16%和14%。而消耗8周RiceX纤维复合物空腹血清葡萄糖和餐前半小时测得的葡萄糖(用糖量计检测)分别降低10%和17%。
对于II型受治疗者,消耗8周RiceX Ricelin观察到空腹葡萄糖和餐前半小时测得的葡萄糖(用糖量计检测)分别降低8%和5%。消耗RiceX纤维复合物观察到这两个参数均降低10%。
血糖参数的这些数据表明,RiceX产物明显地控制和调节糖尿病患者的血葡萄糖水平。更具体地说,这些受治疗者糖基化血红蛋白的降低表明,RiceXRicilin和RiceX纤维复合物的消耗有助于加强血葡萄糖的控制。
K.脂类参数
消耗8周RiceX纤维复合物的I型受治疗者其总胆固醇、低密度脂蛋白-胆固醇、载脂蛋白B和甘油三酯与零时间值相比分别降低10%、16%、10%和7%。高密度脂蛋白-胆固醇无改变。
与I型受治疗者见到脂类参数相比,在II型受治疗者见到脂类参数的更大降低。与零时间值相比,总胆固醇、低密度脂蛋白-胆固醇、载脂蛋白B和甘油三酯分别降低12%、15%、10%和8%。在消耗RiceX纤维复合物后高密度脂蛋白-胆固醇浓度无变化。这些结果表明RiceX纤维复合物显著地控制高血脂症。
表II
I型(胰岛素依赖型糖尿病,IDDM)受治疗者的效果
产物 A(n=22) 产物 B(n=26) 产物 C(n=20)
前 后 %变化 前 后 %变化 前 后 %变化血糖参数静脉采血数据糖基化血红蛋白(%) 10.91 10.92 0 11.25 10.06 -11 11.32 10.23 -10空腹血清葡萄糖 172.00 157.99 -9 174.16 116.97 -33 162.78 131.56 -19(mg/dl)血清胰岛素 49.36 49.71 0 52.75 54.86 4 52.03 51.99 0(微单位/毫升)糖量计数据空腹葡萄糖 159.45 154.95 -3 162.5 137.23 -16 164.95 147.85 -10(mg/dl)餐前半小时葡萄糖 175.00 165.91 -5 168.12 145.35 -14 175.35 144.95 -17(mg/dl)脂类参数血清总胆固醇 181.91 180.07 -1 174.27 166.14 -5 185.52 167.74 -10(mg/dl)血清低密度脂蛋白-胆固醇 137.71 134.16 -3 130.79 122.35 -6 134.41 113.55 -16(mg/dl)血清载脂蛋白B 88.15 86.15 -2 85.69 81.708 -5 84.37 75.96 -10(mg/dl)血清甘油三脂 135.36 134.85 0 134.07 130.13 -3 129.76 120.58 -7(mg/dl)血清高密度脂蛋白-胆固醇 37.65 37.62 0 38.73 38.07 -2 39.29 39.57 0(mg/dl)
表III
II型(非胰岛素依赖型糖尿病,NIDDM)受治疗者的效果
产物 A(n=23) 产物 B(n=31) 产物 C(n=26)
前 后 %变化 前 后 %变化 前 后 %变化血糖参数静脉采血数据糖基化血红蛋白(%) 10.22 10.63 4 10.69 9.65 -10 10.700 9.51 -11空腹血清葡萄糖 158.11 142.28 -10 158.18 106.52 -33 145.42 113.65 -22(mg/dl)血清胰岛素 49.42 49.98 0 48.48 50.31 4 49.45 49.94 0(微单位/毫升)糖量计数据空腹葡萄糖 120.13 121.71 1 128.45 118.16 -8 129.12 115.73 -10(mg/dl)餐前半小时葡萄糖 120.17 129.91 8 129.68 123.61 -5 134.54 120.96 -10(mg/dl)脂类参数血清总胆固醇 182.81 172.79 -5 181.14 171.1 -6 186.04 164.58 -12(mg/dl)血清低密度脂蛋白-胆固醇 146.02 134.97 -8 143.18 131.48 -8 146.46 124.77 -15(mg/dl)血清载脂蛋白B 95.56 94.23 -1 94.92 92.27 -3 95.00 85.62 -10(mg/dl)血清甘油三脂 143.75 139.13 -3 138.85 135.47 -2 143.01 131.24 -8(mg/dl)血精高密度脂蛋白-胆固醇 36.23 36.21 0 34.42 34.33 0 33.64 33.54 0(mg/dl)
实施例2
本实施例阐述酶处理的稳定的米糠的合成。
将1200磅稳定的米糠与570加仑水混合,形成水提取物。混合物搅拌30分钟。加入240克α-淀粉酶,混合10分钟。然后,将混合物抽吸通过一个约190°F的热交换器,使其经过盘管25分钟。然后,将混合物在转鼓式干燥器上干燥至水分在5%以下。
实施例3
本实施例阐述酶处理的稳定的米糠不溶性和可溶性衍生物的合成。
将1200磅稳定的米糠与570加仑水混合,形成水提取物。混合物搅拌30分钟。在混合物中加入240克α-淀粉酶,混合10分钟。
然后,将混合物抽吸通过一个约190°F的热交换器,使其经过盘管25分钟。再将混合物抽吸到置于3,6000 RPM的卧式倾析式离心机中,以每分钟2加仑的速度送入。在离心机中,米糠的可溶性部分与不溶性部分分离。
将可溶性部分在转鼓式干燥器上干燥至水分为2.8%。不溶性部分也在转鼓式干燥器上干燥至水分为4%。本方法得到550磅干燥的米糠不溶物和420磅干燥的米糠可溶性浓缩物。两种产物的化学组成分别列于表IV和V。
实施例4
本实施例将稳定米糠衍生物的成份列表于表IV-VII。
表IV RiceXTM纤维复合物
常量营养素 | |
蛋白质 | 20.5% |
脂肪 | 13.4% |
总膳食纤维(可溶性纤维0-1%) | 49.5% |
碳水化合物 | 3.0% |
灰分 | 10.0% |
水分 | 3.5% |
表IV RiceXTM纤维复合物 (续)
微量营养素 | |
水溶性维生素(mg/100g) | 平均值 |
硫胺素 | 2.00 |
核黄素 | 0.19 |
烟酸 | 30.55 |
泛酸 | 1.90 |
维生素B6 | 1.67 |
生物素 | 0.011 |
矿物质(mg/100g) | 平均值 |
钠 | 16.0 |
钙 | 92.5 |
镁 | 1223.3 |
钾 | 1670.0 |
维生素E和其它“母育酚”(mg/100g) | 平均值 |
α-生育酚 | 0.74 |
γ-生育酚 | 0.40 |
δ-生育酚 | 0.43 |
总生育酚 | 1.19 |
生育酚类 | |
α-生育酚 | 0.59 |
β-胡萝卜素 | 1.55 |
γ-生育酚 | 1.60 |
δ-生育酚 | 0.19 |
总生育酚 | 2.54 |
总母育酚 | 3.73 |
表IV RiceXTM纤维复合物 (续)
维生素A和其它类胡萝卜素(mg/100g) | 平均值 |
α-胡萝卜素 | TBD |
β-胡萝卜素 | TBD |
番茄红素 | TBD |
前叶黄素 | TBD |
叶黄素 | TBD |
玉米黄质 | TBD |
前隐黄质 | TBD |
隐黄质 | TBD |
β-隐黄质 | TBD |
总类胡萝卜素 | TBD |
γ-谷维素(mg/100g) | 平均值 |
174.1 |
植物甾醇(mg/100g) | 平均值 |
谷固醇 | 146.46 |
菜子固醇 | 13.20 |
菜油固醇 | 90.40 |
豆固醇 | 67.15 |
总植物甾醇 | 317.2 |
表V RiceX RICELINTM
常量营养素 | |
蛋白质 | 7.5% |
脂肪 | 26.5% |
总膳食纤维 | 3.0% |
碳水化合物 | 54.5% |
灰分 | 5.0% |
水分 | 3.0% |
微量营养素 | |
水溶性维生素(mg/100g) | 平均值 |
硫胺素 | 3.64 |
核黄素 | 0.46 |
烟酸 | 76.6 |
泛酸 | 5.82 |
维生素B6 | 5.81 |
生物素 | 0.015 |
矿物质(mg/100g) | 平均值 |
钠 | 15.75 |
钙 | 8.33 |
镁 | 170.8 |
钾 | 1562.0 |
维生素E和其它“母育酚”(mg/100g) | 平均值 |
α-生育酚 | 6.80 |
γ-生育酚 | 1.13 |
δ-生育酚 | 0.07 |
总生育酚 | 8.00 |
表V RiceX RICELINTM (续)
α-生育三烯酚 | 4.90 |
β-生育三烯酚 | 0.36 |
γ-生育三烯酚 | 4.48 |
δ-生育三烯酚 | 0.30 |
总生育三烯酚 | 10.0 |
总母育酚 | 18.0 |
维生素A和其它类胡萝卜素(mg/100g) | 平均值 |
α-胡萝卜素 | TBD |
β-胡萝卜素 | TBD |
番茄红素 | TBD |
前叶黄素 | TBD |
叶黄素 | TBD |
玉米黄质 | TBD |
前隐黄质 | TBD |
隐黄质 | TBD |
β-隐黄质 | TBD |
总类胡萝卜素 | TBD |
γ-谷维素(mg/100g) | 平均值 |
248.1 |
植物甾醇(mg/100g) | 平均值 |
谷固醇 | 211.90 |
菜子固醇 | 15.20 |
菜油固醇 | 117.32 |
豆固醇 | 68.69 |
总植物甾醇 | 385.0 |
表VI RiceXTM稳定的米糠
常量营养素 | |
蛋白质 | 14.5% |
脂肪 | 20.5% |
总膳食纤维(可溶性纤维2-6%) | 29.0% |
碳水化合物 | 22.0% |
灰分 | 8.0% |
水分 | 6.0% |
微量营养素 | |
水溶性维生素(mg/100g) | 平均值 |
硫胺素 | 2.65 |
核黄素 | 0.28 |
烟酸 | 46.87 |
泛酸 | 3.98 |
维生素B6 | 3.17 |
生物素 | 0.014 |
矿物质(mg/100g) | 平均值 |
钠 | 8.0 |
钙 | 39.7 |
镁 | 727.0 |
钾 | 1573.0 |
维生素E和其它“母育酚”(mg/100g) | 平均值 |
α-生育酚 | 10.60 |
γ-生育酚 | 1.34 |
δ-生育酚 | 0.07 |
总生育酚 | 11.97 |
表VI RiceXTM稳定的米糠 (续)
α-生育三烯酚 | 7.56 |
β-生育三烯酚 | 0.41 |
γ-生育三烯酚 | 5.36 |
δ-生育三烯酚 | 0.31 |
总生育三烯酚 | 13.60 |
总母育酚 | 25.61 |
维生素A和其它类胡萝卜素(mg/100g) | 平均值 |
α-胡萝卜素 | 0.4 |
β-胡萝卜素 | 37.0 |
番茄红素 | 2.3 |
前叶黄素 | ND |
叶黄素 | 63.8 |
玉米黄质 | 18.4 |
前隐黄质 | 7.4 |
隐黄质 | ND |
β-隐黄质 | ND |
总类胡萝卜素 | 129.3 |
γ-谷维素(mg/100g) | 平均值 |
245.15 |
植物甾醇(mg/100g) | 平均值 |
谷固醇 | 151.47 |
菜子固醇 | 14.61 |
菜油固醇 | 91.57 |
豆固醇 | 58.59 |
总植物甾醇 | 302 |
表VII
RiceXTM稳定的米糠中的抗氧化剂A. γ-谷维素:(ppm) D. 氨基酸:(ppm)
(2206-3000) 色氨酸(2100)
阿魏酸环阿屯酯 组氨酸(3800)
阿魏酸24-亚甲基环阿屯酯 甲硫氨酸(2500)
阿魏酸菜油固醇酯 胱氨酸(336-448)
阿魏酸β-谷固醇酯 半胱氨酸(3200)
阿魏酸豆固醇酯 精氨酸(10800)B. 生育酚和生育三烯酚: E. 多元酚:
(220-320ppm) α-硫辛酸
α-生育酚 阿魏酸
β-生育酚 阿魏酸甲酯
γ-生育酚 P-香豆酸
δ-生育酚 P-芥子酸
α-生育三烯酚 F. 黄酮类和前花色素类:
β-生育三烯酚 异牡荆葡(基)黄酮(Iso Vitexin)
γ-生育三烯酚 黄酮糖苷
生育三烯酚(矫作物) OlegomericC. 植物甾醇类:(2230-4400pp) 前花色素
4-去甲基甾醇类、4-甲基甾醇和 G. 其它抗氧化剂:(ppm)
Brassino Steriods 肌醇
β-谷固醇 (1200-1880)
菜油固醇 肌醇六磷酸
豆固醇 (1500-1710)
△5 Avinsterol 生物素(0.1-0.22)
△7豆固醇 胆碱(930-1150)
Isofucosterol H. 类胡萝卜素:(0.9-1.6ppm)
β-香树素 α-胡萝卜素
Gramisterol β-胡萝卜素
α1-谷甾醇 番茄红素
Obtusifoliol 叶黄素
Branosterol 玉米黄质
28-Homotyphasterol I. 磷脂类:
28-Homosteasternoic Acid 磷脂酰胆碱
6-Deoxycastasterone 磷脂酰乙醇胺
溶血卵磷脂J. 酶类: L. 金属螯合剂:(ppm)
谷胱苷肽过氧化物酶 镁(6250-8440)
甲硫氨酸还原酶 钙(303-500)
超氧化物岐化酶 亚磷(14700-17000)
多元醇氧化酶 M 复合维生素B:(ppm)
天冬氨酸氨基转移酶 硫胺素(22-31)
同工酶 核黄素(2.2-3.5)
AAT-1 烟酸(370-600)
AAT-2 泛酸(36-50)
辅酶Q10 吡哆醇(29-42)K. 多糖类
环阿屯阿魏酸
葡糖苷
二阿魏酸复合物
二阿魏酸+3
葡萄糖+2
钙离子复合物
本说明书中所引用的所有出版物、专利和专利申请,为了各种目的,均在此全部并入本说明书作为参考。
本发明虽然参照优选实施方案及其实施例进行了描述,但本发明的范围并不仅仅限于所描述的那些实施方案。本领域技术人员会明了,对上述发明可作修改和改写,但不背离由所附的权利要求所定义和限制的本发明的精神和范围。
Claims (31)
1.控制哺乳动物血清葡萄糖水平的方法,所述方法包括:摄入选自可溶性部分、不溶性部分、酶处理的稳定的米糠及其混合物的稳定的米糠衍生物,从而降低所述哺乳动物血清葡萄糖水平。
2.如权利要求1所述的方法,其中所述哺乳动物是人。
3.如权利要求1所述的方法,其中所述血清葡萄糖水平的升高系糖尿病所致。
4.如权利要求3所述的方法,其中所述糖尿病是I型。
5.如权利要求3所述的方法,其中所述糖尿病是II型。
6.如权利要求1所述的方法,其中所述稳定的米糠衍生物是可溶性部分。
7.如权利要求6所述的方法,其中所述可溶性部分包含约0%-20%重量比的总膳食纤维素。
8.如权利要求6所述的方法,其中所述可溶性部分包含约35%-75%重量比的非纤维总碳水化合物含量。
9.如权利要求6所述的方法,其中所述可溶性部分包含约20%-35%重量比的总脂肪含量。
10.如权利要求6所述的方法,其中所述可溶性部分包含约5%-15%重量比的总蛋白质含量。
11.如权利要求1所述的方法,其中所述米糠衍生物是不溶性部分。
12.如权利要求11所述的方法,其中所述米糠衍生物是包含约40%-60%重量比的总膳食纤维素含量的不溶性部分。
13.如权利要求11所述的方法,其中所述米糠衍生物是包含约1%-20%重量比非纤维总碳水化合物含量的不溶性部分。
14.如权利要求11所述的方法,其中所述米糠衍生物是包含约10%-20%重量比总脂肪含量的不溶性部分。
15.如权利要求11所述的方法,其中所述米糠衍生物是包含约15%-25%重量比总蛋白质含量的不溶性部分。
16.如权利要求1所述的方法,其中所述米糠衍生物是酶处理的稳定的米糠。
17.如权利要求16所述的方法,其中所述酶处理的稳定的米糠包含约20%-30%重量比的总膳食纤维素含量。
18.如权利要求2所述的方法,其中所述衍生物的摄入量是每天共约10克至约100克。
19.如权利要求18所述的方法,其中所述量以每天至少两次剂量摄入。
20.如权利要求18所述的方法,其中所述量是每天共约10克至约40克。
21.如权利要求18所述的方法,其中所述量是每天共约15克至约30克。
22.如权利要求1所述的方法,其中所述稳定的米糠衍生物选自粉末、食物、食物添加剂、药膳、液体、饮料、乳剂及其混合物组成的组中的一种。
23.控制哺乳动物高血糖的方法,所述方法包括:摄入选自可溶性部分、不溶性部分及其混合物的稳定的米糠衍生物,从而控制所述哺乳动物的高血糖。
24.如权利要求23所述的方法,其中所述米糠衍生物是可溶性部分。
25.如权利要求23所述的方法,其中所述米糠衍生物是不溶性部分。
26.如权利要求23所述的方法,其中所述衍生物以每天共约10克至约100克的量摄入。
27.糖尿病食盒,包括:
(a)选自可溶性部分、不溶性部分及其混合物的稳定的米糠衍生物;
(b)非稻米消费品;及
(c)摄入盒内所述食物的使用说明书。
28.如权利要求27所述的糖尿病食盒,其中所述米糠衍生物是可溶性部分。
29.如权利要求27所述的糖尿病食盒,其中所述米糠衍生物是不溶性部分。
30.如权利要求27所述的糖尿病食盒,其中所述米糠衍生物是粉末、食物、食物补充品、药膳、液体、饮料、乳剂或其混合物。
31.如权利要求27所述的糖尿病食盒,其中所述非稻米消费品选自食用物质、沙拉、面包、食物补充品、药膳、液体、饮料、谷类、酱、运动员排、饮料和高纤维食物组成的组中的一种。
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1998
- 1998-08-28 JP JP2000507391A patent/JP2001513571A/ja active Pending
- 1998-08-28 US US09/143,429 patent/US6303586B1/en not_active Expired - Lifetime
- 1998-08-28 BR BR9811426-3A patent/BR9811426A/pt not_active Application Discontinuation
- 1998-08-28 AU AU92109/98A patent/AU751704B2/en not_active Expired
- 1998-08-28 WO PCT/US1998/017953 patent/WO1999010002A1/en active IP Right Grant
- 1998-08-28 KR KR1020007002174A patent/KR100583211B1/ko not_active IP Right Cessation
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- 1998-08-28 NZ NZ503648A patent/NZ503648A/xx not_active IP Right Cessation
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100356983C (zh) * | 2005-11-18 | 2007-12-26 | 山东大学 | 胃肠造影剂用生物质的生物技术处理方法 |
CN101156679B (zh) * | 2006-10-02 | 2011-07-20 | 何建国 | 米糠营养原液及其制作方法 |
Also Published As
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CA2305665C (en) | 2011-12-06 |
AU751704B2 (en) | 2002-08-22 |
CA2305665A1 (en) | 1999-03-04 |
CN1114438C (zh) | 2003-07-16 |
US6303586B1 (en) | 2001-10-16 |
EP1011702A1 (en) | 2000-06-28 |
AU9210998A (en) | 1999-03-16 |
EP1011702A4 (en) | 2004-01-21 |
ATE531381T1 (de) | 2011-11-15 |
JP2001513571A (ja) | 2001-09-04 |
BR9811426A (pt) | 2002-02-13 |
WO1999010002A1 (en) | 1999-03-04 |
EP1011702B1 (en) | 2011-11-02 |
KR20010023528A (ko) | 2001-03-26 |
KR100583211B1 (ko) | 2006-05-24 |
MXPA00002122A (es) | 2003-06-09 |
NZ503648A (en) | 2002-10-25 |
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