CN102781258A - 包含外源性维生素k2的用于调节炎症的营养组合物 - Google Patents
包含外源性维生素k2的用于调节炎症的营养组合物 Download PDFInfo
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- CN102781258A CN102781258A CN2010800504018A CN201080050401A CN102781258A CN 102781258 A CN102781258 A CN 102781258A CN 2010800504018 A CN2010800504018 A CN 2010800504018A CN 201080050401 A CN201080050401 A CN 201080050401A CN 102781258 A CN102781258 A CN 102781258A
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Abstract
提供了营养组合物以及制备和使用所述营养组合物的方法。在通用实施方案中,本公开内容提供了包含外源性维生素K2的营养组合物。营养组合物还可以包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的另外组分。
Description
相关申请
本申请要求于2009年9月14日提交的美国临时申请序列号61/242,087(代理人案卷编号10358-US-P1)、于2009年10月12日提交的美国临时申请序列号61/250,847(代理人案卷编号10358-US-P2)、于2010年5月25日提交的美国临时申请序列号61/347,945(代理人案卷编号10358-US-P3)和于2010年8月9日提交的美国临时申请序列号61/371,846(代理人案卷编号10358-US-P4)的权益,并且与在本申请的同时提交的题为“包含外源性维生素K2的营养组合物”的另一项申请相互依赖。
背景
概括而言,本公开内容涉及健康和营养。更具体而言,本公开内容涉及包含外源性维生素K2的营养组合物以及制备和使用所述营养组合物的方法。
目前有许多类型的营养组合物上市。营养组合物可以根据营养组合物的特定成分而针对某些消费者类型,例如年轻者、年长者、运动员等。营养组合物还可以根据意欲使用营养组合物来治疗或改善的某些生理状况而进行配制。
营养支持的一个目的是通过增加骨密度和强度以及降低骨折风险的发生率来改善骨健康。由于在儿童的正常生长和发育过程中骨密度改变迅速或者由于潜在的医学病症,儿童可能需要营养组合物来改善骨健康指数以及促进骨生长和骨质量。
概述
提供了含有外源性维生素K2的营养组合物以及制备和使用所述营养组合物的方法。在一般的实施方案中,本公开内容提供了包含外源性K2的营养组合物。营养组合物可以是完全营养物或者作为口服营养补充剂(不完全营养物)。营养组合物可以是为任意哺乳动物、例如人或动物设计的配制物。营养组合物中的活性成分还可以作为组件产品(modular product)被提供。组件产品可以被定义为递送一种或多种作为补充剂的特定营养素的方法,并且不意欲用于唯一营养源。
在一项实施方案中,营养组合物还包含一种或多种益生元(prebiotics)。益生元可以是低聚果糖、菊粉、乳果糖、低聚半聚糖(galactooligosaccharides)、阿拉伯胶、大豆低聚糖(soyoligosaccharides)、低聚木糖、低聚异麦芽糖、低聚龙胆糖、低聚乳果糖(lactosucrose)、低聚葡萄糖(glucooligosaccharides)、果胶低聚糖(pecticoligosaccharides)、瓜尔胶、部分水解的瓜尔胶、糖醇、α葡聚糖、β葡聚糖或其组合。
在一项实施方案中,营养组合物还包含一种或多种益生菌(probiotics)。益生菌可以是酵母属(Saccharomyces)、德巴利酵母属Debaromyces)、念珠菌属(Candida)、毕赤酵母属(Pichia)、球拟酵母属(Torulopsis)、曲霉属(Aspergillus)、根霉属(Rhizopus)、毛霉属(Mucor)、青霉属(Penicillium)、双岐杆菌属(Biifidobacterium)、拟杆菌属(Bacteroides)、梭菌属(Clostridium)、梭杆菌属(Fusobacterium)、蜜蜂球菌属(Melissococcus)、丙酸杆菌属(Propionibacterium)、链球菌属(Streptococcus)、肠球菌属(Enterococcus)、乳球菌属(Lactococcus)、葡萄球菌属(Staphylococcus)、消化链球菌属(Peptostrepococcus)、芽胞杆菌属(Bacillus)、片球菌属(Pediococcus)、微球菌属(Micrococcus)、明串珠菌属(Leuconostoc)、魏斯氏菌属(Weissella)、气球菌属(Aerococcus)、酒球菌属(Oenococcus)、乳杆菌属(Lactobacillus)或其组合。
在另一项实施方案中,营养组合物还包含一种或多种氨基酸。氨基酸可以是丙氨酸、精氨酸、天冬酰胺、天冬氨酸、瓜氨酸、半胱氨酸、谷氨酸、谷氨酰胺、甘氨酸、组氨酸、羟脯氨酸、羟丝氨酸、羟酪氨酸、羟赖氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、牛磺酸、苏氨酸、色氨酸、酪氨酸、缬氨酸、HICA(α-羟基异己酸)、HIVA(α-羟基异戊酸)、HIMVA(α-羟基甲基戊酸)或其组合。
在一项实施方案中,营养组合物还包含一种或多种蛋白质。
在一项实施方案中,营养组合物还包含一种或多种核苷酸。
在一项实施方案中,营养组合物还包含一种或多种合生元(synbiotics)、鱼油、含非海洋ω-3脂肪酸的饮食脂肪源、植物营养素(phytonutrients)和/或抗氧化剂。抗氧化剂可以例如是维生素A、维生素B1、维生素B6、维生素B12、维生素C、维生素D、维生素E、类胡萝卜素、硒、类黄酮、Lactowolfberry、枸杞(wolfberry)、多元酚、番茄红素、叶黄素、木酚素、辅酶Q10(“CoQ10”)、橙皮苷(hesperidine)和谷胱甘肽。
在一项实施方案中,营养组合物是可施用的形式,例如药物制剂、营养配制物、管饲配制物、膳食补充剂、功能食品、饮料产品或其组合。
在另一项实施方案中,本公开内容提供了制备营养组合物的方法。该方法包括将外源性维生素K2和选自磷、镁、钙、维生素D、骨桥蛋白或其组合的组分加入营养组合物中。
在一项供选的实施方案中,本公开内容提供了制备营养组合物的方法。该方法包括将外源性维生素K2和选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白或其组合的组分加入营养组合物中。
在另一项实施方案中,本公开内容提供了改善儿科患者的骨健康(即生长、矿物化、微结构、骨有机基质成分、密度、弹性和强度)的方法。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于需要其的儿童。营养组合物还可以包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白或其组合的组分。
在另一项实施方案中,本公开内容提供了在具有潜在医学病症的儿科患者中促进骨生长和骨质量的方法。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于具有潜在医学病症的儿科患者。
在另一项实施方案中,本公开内容提供了降低儿科患者的骨折风险的方法。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于有骨折风险的儿科患者。
在另一项实施方案中,本公开内容提供了改善骨骼肌健康(即代谢功能、瘦体重和活动性)的方法。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于可以受益于骨骼肌健康改善的患者。
本公开内容的优点是提供了改善的含有外源性维生素K2的营养组合物。
本公开内容的另一个优点是提供了制备改善的营养组合物的方法。
本公开内容的另一个优点是提供了促进骨健康的营养组合物。
本公开内容的另一个优点是提供了在具有潜在医学病症的患者中促进骨生长和骨质量的营养组合物。
本公开内容的另一个优点是提供了使骨折风险最低的营养组合物。
本文描述了另外的特征和优点,它们将从以下详述中清楚地看出。
详述
骨健康的维持对于运动性而言是必需的,骨基质是关键矿物质的重要储库。平均而言,女性在18岁、男性在20岁获得骨量峰值的90%。因此,在这些年龄之前,在儿童的正常生长和发育过程中促进恰当的骨健康和骨生长以及骨质量是重要的。鉴于在青春期过程中骨增长速度加快,提供必需营养素可确保骨形成过程的最佳功能性。而且,在此关键时期未能促进骨矿物质密度可以导致骨强度降低和骨组织微结构退变,这可以在儿童群体中引起脆性骨折的发生。
在儿童期,骨由于在骨内部发生吸收(分解骨的过程)、在其外(骨膜)表面上发生新骨形成而生长。在青春期,骨由于可以在外及内(骨内膜)表面上发生形成而变得更厚。重建过程在整个生命过程中发生,并且在骨达到其骨量峰值的时候(通常在刚20多岁时)成为优势过程。在重建中,骨小梁表面上或骨皮质内部的少量骨被除去,然后在相同位置被替换。重建过程不改变骨的形状,但是它对于骨健康而言仍然是至关重要的。构建和重建在整个生命过程中继续进行,结果大部分成人骨骼约每隔10年被替换。虽然重建在成年期早期占优势,但是构建仍然可以发生,特别是响应于骨减弱而发生。
虽然钙和维生素D是骨无机基质发育的重要营养素,但是骨有机基质的正常发育也需要数种营养素。具体而言,非胶原蛋白如骨钙蛋白、骨桥蛋白的正常代谢需要足够的维生素K和微量矿物质如锌、铜、铁营养。在快速生长期间提供这些营养素可以预防生命后期的骨软化和骨质疏松症。这改善了生活质量,并且还将节省与髋骨折有关的医疗保健费用。
维生素K表示一组具有共同的化学环结构(萘醌)的亲脂性、疏水性和必需的维生素。维生素K的两种最重要的形式是维生素K1(称为叶绿醌或植物甲萘醌的单一化合物)和维生素K2(称为甲萘醌或四烯甲萘醌的一系列类维生素)。还有数种合成形式的维生素K,包括例如维生素K3、K4和K5。
维生素K1是正常饮食中维生素K的主要形式,它由植物、包括例如某些植物油如低芥酸菜子油(canola)和大豆油和在绿叶蔬菜如菠菜、叶甜菜(swiss chard)、花茎甘蓝、甘蓝、花椰菜、羽衣甘蓝和抱子甘蓝中合成。
维生素K2是一组称为甲萘醌(“MK”)的化合物,其具有由可变数目的不饱和类异戊二烯残基组成的侧链,通常指定为MK-n,其中n规定了类异戊二烯的数目。最常见的MK是MK-4和MK-7。MK-4通常由动物器官和肌肉合成,而MK-7通常由细菌在发酵过程中合成。因此,MK-7在发酵产品、包括干酪、凝乳干酪和纳豆(发酵大豆)中特别丰富,并且与维生素K1相比具有特别长的半衰期。
在美国,1至18岁儿童对维生素K的估计平均需要量是基于成人对维生素K的摄入中值的。这些水平被设计成满足正常血液凝固而不是其它维生素K依赖性蛋白质如骨钙蛋白所需要的维生素K水平。羧基化不足(即无活性)骨钙蛋白与羧基化骨钙蛋白的比例可以是维生素K状况的替代标记物。近来的证据表明:相对于成人而言,6至18岁儿童的羧基化不足骨钙蛋白的水平升高。维生素K2允许在不负面影响抗凝参数的情况下施用更有效形式的维生素K,而不是尝试通过摄入较多的维生素K1来增加摄入水平。
与维生素K1相比,维生素K2提供了更好的吸收并通过更长的半衰期提供了更稳定的血清水平。在肝外组织中维生素K2的生物利用度改善还可以允许在正常的生长和发育过程中更大地影响骨健康(即矿物化、微结构和强度)。因此,维生素K2提供了更有效形式的维生素,其中其提高的生物利用度可以在正常的生长和发育过程中影响骨健康。
此外,还存在其中儿科患者的骨生长和骨质量可受到损害的数种医学病症。这类病症可以包括例如发育迟缓、长势不能(failure-to-thrive)、神经肌肉功能障碍、严重的食物变态反应和炎性肠病(例如节段性回肠炎或溃疡性结肠炎)。例如,在患有炎性肠病(“IBD”)的儿童中低骨量的发生率在约30-50%的范围。在该群体中维生素K是被引证的营养缺乏,其有限的生物利用度可以减少骨钙蛋白羧基化以及降低骨强度、骨矿物化和使骨微结构退变。因此,患有任意上述医学病症的儿童可以受益于更有效的维生素K的给予。
维生素K2允许在不负面影响抗凝参数的情况下更有效形式的维生素K,而不是尝试通过摄入较多的维生素K1来增加摄入水平。具体而言,与叶绿醌(维生素K1)相比,维生素K2提供了更好的吸收并通过更长的半衰期提供了更稳定的血清水平。在肝外组织中维生素K2的生物利用度改善还可以允许在炎性肠病(IBD)(节段性回肠炎和结肠炎)患者、尤其是儿科患者中对于改善肌肉骨骼健康(musculoskeletal health)而言产生更大的影响。在患有IBD的儿童中低骨量的发生率在30-50%的范围。在该群体中维生素K是被引证的营养缺乏,其有限的生物利用度可以减少骨钙蛋白羧基化以及降低骨强度、骨矿物化和使骨微结构退变。此外,低的维生素K状态在与节段性回肠炎有关的骨质减少中可以是致病因素。在一些节段性回肠炎患者中注意到的骨质减少和骨吸收速度增加是多因素过程,维生素K缺乏当然仅仅是该过程中的一个因素。低的维生素K水平可以导致骨吸收速度增加,而骨形成速度没有代偿性地增加。在节段性回肠炎患者中,骨转换速度增加伴有骨丢失的风险增加。就骨质减少的营养相关性病因学因素而言,有迹象表明:在患有长期节段性回肠炎的患者中,维生素K缺乏对骨转换的影响比血清25(OH)维生素D浓度更大。维生素K2可以用作用于使该目标群体的骨调控最佳化的关键性微量营养素。
此外,维生素K2对于正在同时进行药物治疗、包括例如皮质类固醇、二膦酸药物或抗凝固药物的儿科患者的骨健康而言也是有效的。类似地,正在进行生物学治疗或患有胃肠(“GI”)受损病症、包括例如短肠综合征、溃疡性结肠炎、乳糜泻、囊性纤维化、肾功能障碍和雄激素缺乏、谷蛋白耐受不良、节段性回肠炎或严重变态反应的儿科患者也可以受益于施用含有外源性维生素K2的营养组合物。
申请人已经出人意料地发现:施用作为营养配制物一部分的外源性维生素K2将在儿童的正常生长和发育过程中改善骨钙蛋白羧基化和改善骨健康指数。此外,补充维生素K2还可以在具有其中骨生长和骨质量可受到损害的潜在医学病症的儿科患者中促进骨生长和骨质量。因此,申请人已经发现:施用外源性维生素K2可在儿科患者中增加骨密度和改善骨组织微结构,由此降低骨折风险的发生率。维生素K2的作用可以在骨质量方面直接看到,从而这种形式的维生素K调节在微结构形态学、矿物化、密度、弹性和机械刚度中涉及的骨有机基质中的蛋白质形成,如通过外周定量计算机体层摄影(“pQCT”)或双能X-射线吸收仪(“DEXA”)所测定的那样。维生素K2对于正在同时进行药物治疗的患者的骨健康而言也可以是有效的。
一般而言,骨密度表示为骨量(表示为穿过骨的光子衰减程度或骨矿物质含量(BMC))与胶片上骨成像(即面积)之间的关系(表示为BMC/cm2)。此外,pQCT是在三维上评价外周骨的方法(测定体积),它常应用于前臂或胫骨。放射源(通常为x-射线)和传感器围绕所检查的骨进行旋转,所检查的骨是在计算机屏幕上以三维(3-D)图像重新构建的那些。pQCT是评价骨几何形状的最佳技术,尽管灵敏度随着评价的位置而改变。与大多数其它技术不同,pQCT测定了真实的骨密度(体积矿物质骨密度),因为它使不是由投影面积、而是由所检查的骨的体积推导的骨矿物质含量正态化。pQCT还可用于计算SSI(骨抗扭转指数)。该指数考虑了骨几何形状和骨矿物质特征。参见Geometry and bone density,Radetti,G.等人,Panminerva Med 2006;48:181-6。
DEXA基于x-射线光谱测定法,其基本原理基于由2种不同能量源发射的x-射线的衰减程度。DEXA通常用于评价腰部或近侧股骨矿物化。DEXA的准确度为4-10%,变异系数为1-1.5%。参见Id。
因此,本公开内容涉及包含外源性K2的营养组合物以及制备和使用所述营养组合物的方法。本公开内容还涉及使用pQCT和DEXA来测定骨密度和骨组织微结构。本公开内容的营养组合物的实施方案可促进骨密度、矿物化和机械刚度的增加以及改善的骨组织微结构,同时使对血液凝固和骨折风险的潜在负面作用最低。因此,使用外源性维生素K2可以允许在儿科患者中增进骨健康以及与之相关的益处。采用如上所述的pQCT和DEXA,能够准确地测定骨密度和骨微结构以证明本申请所要求的营养组合物的作用。
在通用实施方案中,本公开内容提供了包含外源性维生素K2的营养组合物。该营养组合物还可以包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。
如本文所用的术语“营养组合物”包括但不限于完全营养组合物、部分或不完全营养组合物和对疾病或病症特定的营养组合物。完全营养组合物(即含有所有必需的常量和微量营养素的那些)可以用作患者的唯一营养源。患者可以从该完全营养组合物中接受其营养需求的100%。部分或不完全营养组合物不含有所有必需的常量和微量营养素,不能用作患者的唯一营养源。部分或不完全营养组合物可以用作营养补充剂。对疾病或病症特定的营养组合物是递送营养素或药物的组合物,它可以是完全或部分营养组合物。
外源性维生素K2可以与其它成分组合用于促进骨生长和骨质量。例如,当与选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分组合使用时,外源性维生素K2可以更有效地工作以支持儿科患者的骨健康。当与氨基酸(例如亮氨酸)、具有低的含硫氨基酸含量的蛋白质、脂质(n3:n6)、生物活性肽、蛋白酶抑制剂、肌酸等组合使用时,外源性维生素K2也可以更有效地工作以支持骨健康。
在一项实施方案中,营养组合物还包含一种或多种益生元。如本文所用的益生元是选择性发酵的成分,其允许胃肠道微生物区系的组成和/或活性发生特定的改变,这些改变给宿主的安康和健康带来益处。益生元的非限制性实例包括低聚果糖、菊粉、乳果糖、低聚半聚糖、阿拉伯胶、大豆低聚糖、低聚木糖、低聚异麦芽糖、低聚龙胆糖、低聚乳果糖、低聚葡萄糖、果胶低聚糖、瓜尔胶、部分水解的瓜尔胶、糖醇、α葡聚糖、β葡聚糖或其组合。
在一项实施方案中,营养组合物还包含一种或多种益生菌。如本文所用的益生微生物(下文称为“益生菌”)优选是这样的微生物(活的,包括半活的或弱化的和/或非复制的)、代谢物、微生物细胞制备物或微生物细胞组分:当以足够的量施用时可以给宿主带来健康益处,更具体而言,可以通过改善其肠道微生物平衡而有益地影响宿主,从而对宿主的健康或安康产生作用。通常,人们认为这些微生物可抑制或影响肠道中致病菌的生长和/或代谢。益生菌还可以激活宿主的免疫功能。因为这个原因,已经有许多不同的方法将益生菌包含到食品中。益生菌的非限制性实例包括酵母属、德巴利酵母属、念珠菌属、毕赤酵母属、球拟酵母属、曲霉属、根霉属、毛霉属、青霉属、双岐杆菌属、拟杆菌属、梭菌属、梭杆菌属、蜜蜂球菌属、丙酸杆菌属、链球菌属、肠球菌属、乳球菌属、葡萄球菌属、消化链球菌属、芽胞杆菌属、片球菌属、微球菌属、明串珠菌属、魏斯氏菌属、气球菌属、酒球菌属、乳杆菌属或其组合。
在另一项实施方案中,营养组合物还包含一种或多种氨基酸。氨基酸的非限制性实例包括丙氨酸、精氨酸、天冬酰胺、天冬氨酸、瓜氨酸、半胱氨酸、谷氨酸、谷氨酰胺、甘氨酸、组氨酸、羟脯氨酸、羟丝氨酸、羟酪氨酸、羟赖氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、牛磺酸、苏氨酸、色氨酸、酪氨酸、缬氨酸、HICA(α-羟基异己酸)、HIVA(α-羟基异戊酸)、HIMVA(α-羟基甲基戊酸)或其组合。在优选的实施方案中,氨基酸的非限制性实例包括脯氨酸、羟脯氨酸、羟酪氨酸、羟赖氨酸和羟丝氨酸及其组合。
在一项实施方案中,营养组合物还包含一种或多种蛋白质。
在一项实施方案中,营养组合物还包含一种或多种核苷酸。
在一项实施方案中,营养组合物还包含一种或多种合生元、鱼油、含非海洋ω-3脂肪酸的饮食脂肪源、鲍曼-伯克(Bowman Birk)抑制剂、植物营养素和/或抗氧化剂。如本文所用的合生元是含有一起工作以改善肠道微生物区系的益生元和益生菌的补充剂。鱼油的非限制性实例包括二十二碳六烯酸(“DHA”)和二十碳五烯酸(“EPA”)。植物营养素的非限制性实例包括槲皮素、姜黄素和柠檬苦素。抗氧化剂是能够延缓或阻止其它分子氧化的分子。抗氧化剂的非限制性实例包括维生素A、类胡萝卜素、维生素C、维生素E、硒、类黄酮、Lactowolfberry、枸杞(wolfberry)、多元酚、番茄红素、叶黄素、木酚素、辅酶Q10(“CoQ10”)、橙皮苷和谷胱甘肽。
在另一项实施方案中,本公开内容提供了制备营养组合物的方法。该方法包括将有效量的外源性K2和选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白或其组合的组分加入营养组合物中,例如以改善儿科患者的骨健康。营养组合物可以是可施用的形式,例如药物制剂、营养配制物、管饲配制物、膳食补充剂、功能食品、饮料产品或其组合。
在另一项实施方案中,本公开内容提供了给患者定制治疗或剂量的方法,该方法是基于当决定维生素K2影响骨健康的可能性时作为评价参数的遗传素质而进行的。在带有独特基因型的个体中,补充维生素K2可以是更有效的。
如本文所用的“管饲”配制物优选是施用于动物胃肠道系统的完全或不完全营养产品,除通过口服施用外,包括但不限于鼻胃管、口胃管、胃管、空肠造口术置管(J-管)、经皮内镜胃造口术(PEG)、孔、例如提供到达胃、空肠的通路的胸壁孔和其它适宜的孔。
如本文所用的“有效量”优选是这样的量:其在个体中预防缺乏、治疗疾病或医学病症,或者更概括而言,其减轻症状、控制疾病进程或给个体提供营养的、生理学的或医学的益处。治疗可以是与患者或与医师有关的。此外,虽然术语“个体”和“患者”在本文中常用于指人,但是本发明不受该限制。因此,术语“个体”和“患者”指患有可得益于所述治疗的医学病症或处于该医学病症的风险中的任意动物、哺乳动物或人。
如本文所用的动物包括但不限于哺乳动物,其包括但不限于啮齿动物、水生哺乳动物、家养动物如犬和猫、农场动物如羊、猪、牛和马以及人。当使用术语动物或哺乳动物或其复数时,可以理解,其还应用于能够具有本段落上下文中所呈现的或意欲呈现的作用的任意动物。
如本文所用的“完全营养”优选是这样的营养产品:其含有对正在使用其的动物而言足以作为唯一营养源的足够类型和水平的常量营养素(蛋白质、脂肪和碳水化合物)和微量营养素。
如本文所用的“不完全营养”优选是这样的营养产品:其不含有对正在使用其的动物而言足以作为唯一营养源的足够水平的常量营养素(蛋白质、脂肪和碳水化合物)或微量营养素。
如本文所用的“长期施用”优选是连续施用6周以上。
如本文所用的哺乳动物优选包括但不限于啮齿动物、水生哺乳动物、家养动物如犬和猫、农场动物如羊、猪、牛和马以及人。当使用术语哺乳动物时,可以理解,其还应用于能够具有该哺乳动物所呈现的或意欲呈现的作用的其它动物。
术语“微生物”意欲包括细菌、酵母和/或真菌、含微生物的细胞生长培养基或者其中培养有微生物的细胞生长培养基。
如本文所用的“益生元”优选是在肠道中选择性地促进有益细菌生长或抑制致病菌生长的食物物质。它们在摄入其的人的胃和/或上肠道内不被灭活或者在GI道内不被吸收,但是它们被胃肠道微生物区系和/或益生菌发酵。益生元例如在如下文献中进行了定义:Glenn R.Gibson和Marcel B.Roberfroid,Dietary Modulation of the Human Colonic Microbiota:Introducing the Concept of Prebiotics,J.Nutr.1995 125:1401-1412。
如本文所用的“短期施用”优选是连续施用6周以下。
如本文所用的术语“治疗”和“减轻”优选是预防性或防止性治疗(阻止和/或减缓目标病理学病症或紊乱的发展)以及治愈性、治疗性或疾病调整性治疗,包括治愈、减缓、减轻所诊断病理学病症或紊乱的症状和/或使其发展停止的治疗性措施;以及治疗处于患病风险或被怀疑已经患病的患者以及患病或已经被诊断为患有疾病或医学病症的患者。术语“治疗”还指在未患疾病、但是易发生不健康状态如氮失衡或肌肉损失的个体中维持和/或促进健康。术语“治疗”和“减轻”还意欲包括增强或另外地增进一种或多种原来的预防性或治疗性措施。
如本文所用的合生元是含有一起工作以改善肠道微生物区系的益生元和益生菌的补充剂。
如本文所用的“正常骨生长”优选包括:在儿童期和青春期,骨通过构建而成形,这允许在一个位置形成新骨和在相同骨内的另一个位置除去旧骨。该过程允许各块骨在尺寸上生长(长度生长和周围生长)和在空间上转移。在儿童期,骨由于在骨内部发生吸收(分解骨的过程)、在其外(骨膜)表面上发生新骨形成而生长。在青春期,骨由于可以在外及内(骨内膜)表面上发生形成而变得更厚。重建过程在整个生命过程中发生,并且在骨达到其骨量峰值的时候(通常在刚20多岁时)成为优势过程。在重建中,骨小梁表面上或骨皮质内部的少量骨被除去,然后在相同位置被替换。重建过程不改变骨的形状,但是它对于骨健康而言仍然是至关重要的。构建和重建在整个生命过程中继续进行,结果大部分成人骨骼约每隔10年被替换。虽然重建在成年期早期占优势,但是构建仍然可以发生,特别是响应于骨减弱而发生。
如本文所用的“核苷酸”优选被理解为是脱氧核糖核酸(“DNA”)或核糖核酸(“RNA”)的亚单位。它是由含氮碱基、磷酸分子和糖分子(在DNA中为脱氧核糖,在RNA中为核糖)组成的有机化合物。单个核苷酸单体(单个单位)连接在一起形成聚合体或长链。外源性核苷酸特别地由膳食补充剂提供。外源性核苷酸可以是单体形式,例如5'-单磷酸腺苷(“5'-AMP”)、5'-单磷酸鸟苷(“5'-GMP”)、5'-单磷酸胞嘧啶(“5'-CMP”)、5'-单磷酸尿嘧啶(“5'-UMP”)、5'-单磷酸肌苷(“5'-IMP”)、5'-单磷酸胸腺嘧啶(“5'-TMP”)或其组合。外源性核苷酸还可以是聚合形式,例如完整的RNA。可以有多种来源的聚合形式,例如酵母RNA。
营养产品优选被理解为还包含任意数目的另外成分,包括例如一种或多种维生素、矿物质、糖、可药用载体、赋形剂、调味剂或着色剂。
如本文所用的术语“蛋白质”、 “肽”、 “寡肽”或“多肽”优选被理解为指包括单一氨基酸(单体)、通过肽键连接在一起的两个或多个氨基酸(二肽、三肽或多肽)、胶原蛋白、前体、同系物、类似物、模拟物、盐、前药、代谢物或其片段或者它们的组合的任意组合物。为了清楚目的,任意以上术语可以互换使用,另有说明除外。应当理解:多肽(或肽或蛋白质或寡肽)通常含有除常称为20种天然存在的氨基酸的20种氨基酸以外的氨基酸,并且很多氨基酸、包括末端氨基酸可以在给定的多肽中通过自然过程如糖基化和其它翻译后修饰或者通过本领域熟知的化学修饰技术进行修饰。可以在本发明的多肽中存在的已知修饰包括但不限于乙酰化、酰化、ADP-核糖基化、酰胺化、黄烷类或血红素部分的共价连接、多核苷酸或多核苷酸衍生物的共价连接、脂质或脂质衍生物的共价连接、磷脂酰肌醇的共价连接、交联、环化、二硫键形成、脱甲基、共价交联的形成、胱氨酸的形成、焦谷氨酸的形成、甲酰化、γ-羧基化、糖化、糖基化、糖基磷脂酰肌醇(GPI)膜锚着点形成、羟化、碘化、甲基化、肉豆蔻酰化、氧化、蛋白酶解加工、磷酸化、异戊烯化、外消旋化、硒酰化(selenoylation)、硫酸化、转移-RNA介导的氨基酸与多肽的加成如精氨酰化以及遍在蛋白化。术语“蛋白质”还包括“人工蛋白质”,后者指由交替重复的肽组成的直链或非直链多肽。
如本文所用的“植物化学物”或“植物营养素”是在许多食物中发现的无营养化合物。植物化学物是具有超过基本营养的健康益处的功能食品,它们是来自植物来源的促进健康的化合物。如本文所用的“植物化学物”和“植物营养素”指给使用者带来一种或多种健康益处的由植物产生的任意化学物质。植物化学物可以通过任意方式、包括局部、肠内和/或胃肠道外施用。如本文所用的植物化学物和植物营养素的非限制性实例包括以下那些:
1.酚类化合物,包括单酚(例如:芹菜脑、鼠尾草酚、香芹酚、莳萝油脑(Dillapiole)、Rosemarinol);类黄酮(多元酚),包括黄酮醇(例如:槲皮素、姜酚、山柰酚、杨梅黄酮、芦丁、异鼠李亭)、黄烷酮(例如:橙皮苷、柚苷配基、水飞蓟宾、圣草酚)、黄酮(例如:芹菜素、柑橘黄酮、四羟黄酮)、黄烷-3-醇(例如:儿茶素、(+)-儿茶素、(+)-棓儿茶素、(-)-表儿茶素、(-)-表棓儿茶素、(-)-表棓儿茶素棓酸酯(EGCG)、(-)-表儿茶素3-棓酸酯、茶黄素、茶黄素-3-棓酸酯、茶黄素-3'-棓酸酯、茶黄素-3,3'-二棓酸酯、茶红素(Thearubigins))、花色素苷(flavonals)和花色素(例如:花葵素、芍药素、矢车菊色素、翠雀色素、锦葵色素、矮牵牛素)、异黄酮(植物雌激素)(例如:黄豆苷元(芒柄花黄素)、染料木黄酮(生原禅宁A)、黄豆黄素)、二氢黄酮醇、查耳酮、配糖(=Coumestans)(植物雌激素)和考迈斯托醇;酚酸(例如:鞣花酸、棓酸、鞣酸、香兰素、姜黄素);羟基肉桂酸(例如:咖啡酸、绿原酸、肉桂酸、阿魏酸、香豆素);木酚素(植物雌激素)、水飞蓟素、Secoisolariciresinol、松脂酚和落叶松树脂醇);酪醇酯(例如:酪醇、羟基酪醇、Oleocanthal、齐墩果苷);Stilbenoids(例如:白藜芦醇、蝶茋(pterostilbene)、四羟反式茋(Piceatannol))和Punicalagins;
2.萜类(类异戊二烯),包括类胡萝卜素(类四萜)、包括胡萝卜素(例如:α-胡萝卜素、β-胡萝卜素、γ-胡萝卜素、δ-胡萝卜素、番茄红素、链孢红素、六氢番茄红素、八氢番茄红素)和叶黄素(例如:斑蝥黄、隐黄质、玉米黄质、虾青素、叶黄素、玉红黄质);一帖类(例如:苧烯、紫苏子醇);皂草苷;脂质,包括:植物甾醇(例如:菜油甾醇、β-谷甾醇、γ-谷甾醇、豆甾醇)、生育酚(维生素E)以及ω-3、6和9脂肪酸(例如:γ-亚麻酸);三萜系化合物(例如:齐墩果酸、熊果酸、桦木酸、Moronic acid);
3.甜菜红,包括β-花青素(例如:甜菜苷、异甜菜苷、probetanin、新甜菜苷(neobetanin));和甜菜黄素(非糖苷型)(例如:梨果仙人掌黄素和仙人掌黄素(Vulgaxanthin));
4.有机硫化物,包括Dithiolthiones(异硫氰酸盐)(例如:Sulphoraphane);和Thiosulphonates(葱属化合物)(例如:烯丙基甲基三硫和二烯丙基硫醚)、吲哚化合物、硫代葡萄糖酸盐(glucosinolates)、包括吲哚-3-甲醇;萝卜硫烷;3,3'-二吲哚基甲烷;黑芥子苷;蒜素;蒜氨酸;异硫氰酸丙烯酯;胡椒碱;顺式-丙硫醛-S-氧化物;
5.蛋白质抑制剂,包括蛋白酶抑制剂;
6.其它有机酸,包括草酸、植酸(六磷酸肌醇);酒石酸;和漆树酸;以及
7.它们的组合。
如本文所用的术语“抗氧化剂”优选被理解为包括任意一种或多种抑制由活性氧簇(ROS)和其它基团和非基团种类促进的氧化或反应的各种物质(如β-胡萝卜素(维生素A前体)、维生素C、维生素E和硒)。
如本文所用的术语“维生素”优选被理解为在少量的情况下对于身体的正常生长和活动而言是必需的并且由植物和动物食物天然获得或者通过合成制得的各种脂溶性或水溶性有机物质中的任一种(非限制性的实例包括维生素A、维生素B1、维生素B6、维生素B12、维生素C、维生素D、维生素E),包括它们的维生素原、衍生物和类似物。
如本说明书和所附权利要求书中所用的单数形式包括复数指示物,上下文另有清楚说明除外。因此,例如,称谓“多肽”包括两种或多种多肽的混合物,等等。
如本文所用的“约”优选被理解为指在数字范围内的数。而且,本文的所有数字范围应理解为包括该范围内的所有整数或分数。
在供选的实施方案中,本公开内容提供了制备营养组合物的方法。该方法包括将外源性维生素K2和选自磷、镁、锌、铁、铜、锰、钙、维生素D、维生素类似物、骨桥蛋白或其组合的组分加入营养组合物中。在另一项实施方案中,本公开内容提供了改善儿科患者的骨健康(即生长、矿物化、微结构、骨有机基质成分、密度、弹性和强度)的方法。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于需要其的儿童。营养组合物还可以包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白或其组合的组分。在另一项实施方案中,本公开内容提供了在具有潜在医学病症的儿科患者中促进骨生长和骨质量的方法。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于具有潜在医学病症的儿科患者。在另一项实施方案中,本公开内容提供了降低儿科患者的骨折风险的方法。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于有骨折风险的儿科患者。
营养组合物可以包含施用量为约1μg/日至约100μg/日的外源性维生素K2。外源性维生素K2还可以以如下量施用:约10μg/日至约95μg/日,或约20μg/日至约90μg/日,或约30μg/日至约85μg/日,或约50μg/日至约80μg/日,或1μg/日、5μg/日或10μg/日或15μg/日或20μg/日或25μg/日或30μg/日或35μg/日或40μg/日或45μg/日或50μg/日或55μg/日或60μg/日或65μg/日或70μg/日或75μg/日或80μg/日或85μg/日或90μg/日、95μg/日或100μg/日。
通过使用本公开内容的实施方案中的营养组合物,在儿童的正常生长和发育过程中改善骨钙蛋白羧基化和改善骨健康指数将有助于降低骨折风险。类似地,施用本营养组合物还可以提高维生素K的生物利用度,这可导致增加骨钙蛋白羧基化、骨强度、骨矿物化和改善骨微结构。
在另一项实施方案中,本发明提供了改善骨骼肌健康(即代谢功能、瘦体重和活动性)的方法。肌酸激酶的骨骼肌同功酶对维生素K缺乏敏感。肌酸激酶是厌氧能量产生所必需的反应物。维生素K状态的改善可以将肌肉疲劳降到最低并使能量产生最佳化以支持合成代谢过程如蛋白质合成用于肌肉量增加。瘦体重的保持可有助于维持功能活动性。该方法包括将包含有效量的外源性维生素K2的营养组合物施用于可以受益于骨骼肌健康改善的患者。
在另一项实施方案中,本发明提供了通过施用维生素K2减轻炎症的方法。
K2和炎症
蛋白质合成总体速率的急剧控制主要在翻译起始的水平上通过调节各种真核起始因子(eIF)来实行。被称为哺乳动物雷帕霉素靶标(mTOR)的蛋白激酶充当通过生长因子和氨基酸向翻译起始的mRNA结合步骤进行信号传导的会聚点,它参与调节真核起始因子4E的结合蛋白、即4E-BP1的磷酸化。它还用于控制70-kDa核糖体蛋白S6激酶(S6K1)的磷酸化状态。这些翻译起始事件的调节允许更立即地控制蛋白质合成,并且对与急剧的代谢或营养改变有关的变化作出响应。
规范NF-κB途径涉及p65-p50异二聚体的核转运。当IκB被IκB激酶复合物所磷酸化时,则发生NF-κB的激活,从而导致IκB的遍在蛋白化和降解以及NF-κB二聚体的核易位。细胞因子如TNF-α是规范NF-κB异二聚体的有效激活剂,该激活与肌肉蛋白损失相关。
方法
将雄性Sprague-Dawley大鼠(175g)在12小时光:暗循环条件下饲养,自由取食(Harlan-Teklad啮齿动物饲料,麦迪逊,WI)和饮水。通过口服管饲给动物施用日剂量的维生素K2(MK-7)或盐水(对照)达7天。制备维生素K2的储备液,其含有在缓冲液A(0.15M NaCl,0.05M Tris-HCl,pH7.5)中的3.5g/L HCO-60和1g/L M&-7。通过超声处理、在振幅为6pm的5组5个脉冲过程中使K2溶解。由此得到的溶液是澄清、均匀和稳定的。在临近施用维生素K时,将储备液用缓冲液A稀释5倍,产生0.7g/L的最终HCO-60浓度。用0.7g/L HCO-60在缓冲液A中进行另外的稀释(按要求)。在每个稀释步骤之后如上所述进行超声处理。在所有情况中,将维生素K2以0.5mL样品(含有25或50微克口服剂量)施用于大鼠。
在最后一天(第7天),给啮齿动物施用维生素K2,2小时后经腹膜内(0.5mg/kg体重)给予IP剂量的LPS(大肠杆菌(Escherichia coli)血清型O111:B4,L2630,西格玛(Sigma)公司)。4小时后处死动物。
蛋白质合成的测定——采用血清苯丙氨酸的比放射性作为前体库的指示,由放射性苯丙氨酸进入总混合肌肉蛋白的速率估计了合成的分步速率(fractional rate)(Ks)。采用放射性标记的苯丙氨酸掺入蛋白质的真实时间作为从注射开始直至肌肉在液氮中冷冻所经过的时间。
mTOR向eIF进行信号传导的分析——将腓肠肌称重,在7体积的缓冲液中匀化,所述缓冲液含有20mM HEPES(pH7.4)、100mM氯化钾、0.2mM EDTA、2mM EGTA、50mM氟化钠、50mM磷酸甘油、0.1mM苯甲磺酰氟、1mM苄脒、1mM二硫苏糖醇(DTT)和0.5mM钒酸钠。将剩余的匀化物于4°C以10,000×g离心10分钟。将所得上清液与等体积的SDS样品缓冲液合并,然后进行蛋白免疫印迹分析。对样品的4E-BP1(Thr37)和核糖体蛋白S6(Ser 235/236)的磷酸化状况进行了分析,抗-磷酸特异性抗体由Cell Signaling Technology(Beverly,MA)获得。此外,还对样品的磷酸化IKKα/β(Ser176/180;Cell Signaling Technology)和磷酸化p65(Ser536;Cell Signaling Technology)进行了分析。
结果
与用LPS治疗的动物相比,用K2治疗啮齿动物导致血浆TNF-α的升高显著降低。此外,与LPS治疗相比,维生素K2还导致对IKKα/β和NFκBp65诱导而言的磷酸化下降显著减弱。最后,与LPS治疗相比,K2消除了4E-BP1(Thr-37)和核糖体蛋白S6磷酸化的下降,并且在炎性脓毒病条件下混合肌肉蛋白合成的分步速率被更大地保持。
在另一项实施方案中,本发明提供了减轻炎症的方法,该方法包括:将包含外源性维生素K2的营养组合物施用于需要其的患者。在另一项实施方案中,该营养组合物还包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。在另一项实施方案中,该营养组合物还包含至少一种抗氧化剂。在另一项实施方案中,该营养组合物还包含至少一种植物营养素。在另一项实施方案中,患者是儿童。
在另一项实施方案中,本发明提供了减轻炎症的作用的方法,该方法包括:将包含外源性维生素K2的营养组合物施用于需要其的患者。在另一项实施方案中,该营养组合物还包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。在另一项实施方案中,该营养组合物还包含至少一种抗氧化剂。在另一项实施方案中,该营养组合物还包含至少一种植物营养素。在另一项实施方案中,患者是儿童。
在另一项实施方案中,本发明提供了阻止炎症的作用的方法,该方法包括:将包含外源性维生素K2的营养组合物施用于需要其的患者。在另一项实施方案中,该营养组合物还包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。在另一项实施方案中,该营养组合物还包含至少一种抗氧化剂。在另一项实施方案中,该营养组合物还包含至少一种植物营养素。在另一项实施方案中,患者是儿童。
在另一项实施方案中,本发明提供了降低在炎症条件下血浆TNF-α升高的方法,该方法包括:将包含外源性维生素K2的营养组合物施用于需要其的患者。在另一项实施方案中,该营养组合物还包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。在另一项实施方案中,该营养组合物还包含至少一种抗氧化剂。在另一项实施方案中,该营养组合物还包含至少一种植物营养素。在另一项实施方案中,患者是儿童。
在另一项实施方案中,本发明提供了减弱在炎症条件下对IKKα/β和NFκB p65诱导而言的磷酸化下降的方法,该方法包括:将包含外源性维生素K2的营养组合物施用于需要其的患者。在另一项实施方案中,该营养组合物还包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。在另一项实施方案中,该营养组合物还包含至少一种抗氧化剂。在另一项实施方案中,该营养组合物还包含至少一种植物营养素。在另一项实施方案中,患者是儿童。
在另一项实施方案中,本发明提供了消除在炎症条件下4E-BP1(Thr-37)和核糖体蛋白S6磷酸化降低的方法,该方法包括:将包含外源性维生素K2的营养组合物施用于需要其的患者。在另一项实施方案中,该营养组合物还包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。在另一项实施方案中,该营养组合物还包含至少一种抗氧化剂。在另一项实施方案中,该营养组合物还包含至少一种植物营养素。在另一项实施方案中,患者是儿童。
在另一项实施方案中,本发明提供了在炎症条件下保持混合肌肉蛋白合成的分步速率的方法,该方法包括:将包含外源性维生素K2的营养组合物施用于需要其的患者。在另一项实施方案中,该营养组合物还包含选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分。在另一项实施方案中,该营养组合物还包含至少一种抗氧化剂。在另一项实施方案中,该营养组合物还包含至少一种植物营养素。在另一项实施方案中,患者是儿童。
应当理解,对本文所述的目前优选的实施方案进行各种改变和变通将是本领域技术人员显而易见的。在不背离本主题的宗旨和范围的情况下以及在不减少其预期优点的情况下可以进行这类改变和变通。因此,预期这类改变和变通应包括在所附权利要求内。
Claims (20)
1.调节炎症的作用的方法,该方法包括:将包含有效量的外源性维生素K2的营养组合物施用于需要其的患者。
2.权利要求1的方法,其中外源性维生素K2选自MK-4、MK-7及其组合。
3.权利要求1的方法,其中外源性维生素K2是MK-7。
4.权利要求1的方法,其中外源性维生素K2的有效量为约1μg至约100μg。
5.权利要求1的方法,其中外源性维生素K2的有效量为约20μg至约90μg。
6.权利要求1的方法,其中外源性维生素K2的有效量为约50μg至约80μg。
7.权利要求1的方法,其中营养组合物是选自药物制剂、营养配制物、管饲配制物、膳食补充剂、功能食品和饮料产品的可施用的形式。
8.权利要求1的方法,其中营养组合物还包含至少一种益生元、益生菌、合生元、氨基酸、蛋白质、核苷酸、鱼油、含非海洋ω-3脂肪酸的饮食脂肪源、植物营养素、抗氧化剂及其组合中。
9.权利要求7的营养组合物,其中氨基酸选自脯氨酸、羟脯氨酸、羟酪氨酸、羟赖氨酸和羟丝氨酸及其组合。
10.权利要求1的方法,其中所述的调节炎症的作用是减轻炎症的作用。
11.权利要求1的方法,其中所述的调节炎症的作用是阻止炎症的作用。
12.权利要求1的方法,其中所述的调节炎症的作用是降低在炎症条件下血浆TNF-α的升高。
13.权利要求1的方法,其中所述的调节炎症的作用是减弱在炎症条件下对IKKα/β和NFκB p65诱导而言的磷酸化下降。
14.权利要求1的方法,其中所述的调节炎症的作用是消除在炎症条件下4E-BP1(Thr-37)和核糖体蛋白S6磷酸化降低。
15.权利要求1的方法,其中所述的调节炎症的作用是在炎症条件下保持混合肌肉蛋白合成的分步速率。
16.权利要求1的方法,还包括如下步骤:
a)确定患者的遗传素质以确定用外源性维生素K2治疗的可能功效;和
b)如果被确定为有效,则将包含有效量的外源性维生素K2和选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的组分的营养组合物施用于需要其的儿童。
17.权利要求16的方法,其中所述的遗传素质是确定基因型。
18.权利要求16的方法,其中所述的遗传素质被用于确定所述外源性维生素K2的剂量。
19.权利要求1的方法,其中患者是儿童。
20.权利要求1的方法,其中患者患有发育迟缓、长势不能、炎性肠病、节段性回肠炎、与节段性回肠炎有关的骨质减少、结肠炎、溃疡性结肠炎、乳糜泻、谷蛋白耐受不良、神经肌肉功能障碍、囊性纤维化、肾功能障碍、雄激素缺乏、严重的食物变态反应、短肠综合征或其组合中的至少一种。
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