CN103458710A - 具有α-HICA和瓜氨酸的营养组合物 - Google Patents
具有α-HICA和瓜氨酸的营养组合物 Download PDFInfo
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Abstract
本发明提供了用于使肌肉蛋白质合成最大化同时使肌肉蛋白质分解代谢最小化的营养组合物及其使用方法。以这种方式,所述营养组合物可提供保留瘦体重,其帮助避免丧失独立性和功能性,以及改善尤其是处于少肌症和脆弱风险中的老年人的生活质量。所述营养组合物包括α-羟基异己酸和瓜氨酸。该组合物可包括其他功能成分如,但不限于乳清蛋白质,包括乳清蛋白质胶束、益生元纤维、α-酮戊二酸、二十碳五烯酸、L-肉碱、核苷酸和氨基酸。还提供向有其需要的个体施用这种营养品的方法。
Description
发明背景
本公开内容一般涉及健康和营养。更具体地,本公开内容涉及具有α-羟基异己酸的营养组合物及其使用方法。
目前市场上存在许多类型的营养组合物。基于营养组合物的具体成分,营养组合物可以针对某些消费者类型,例如年轻人、老年人、运动员等。例如,老年人和患有某些疾病的个体经常经受瘦体重减少,这至少部分是由于肌肉蛋白质合成减少(如sarconpenia),由于疾病或存在炎症而减少的摄入或增加的需求。瘦体重的减少可导致代谢稳定性(葡糖耐量、胰岛素敏感)、独立性、功能性和生活质量的丧失,以及认知能力的减退。因此,这些个体通过施用针对使肌肉组织的合成代谢最大化并使其分解代谢最小化的饮食显著受益。所述饮食还会通过将不同类型的功能化合物(其提供不同类型的生理优势)组合到营养组合物中以向所述个体提供其他益处。
因此,营养支持的一个目标是为需要提高肌肉性能和/或维持瘦体重和肌肉强度/力量的个体提供营养组合物,其为所述个体提供生理益处。
发明概述
本公开内容涉及具有α-羟基异己酸和瓜氨酸的营养组合物及其使用方法。在一个实施方案中,所述营养组合物包括有效量的α-羟基异己酸和有效量的瓜氨酸。
在一个实施方案中,所述α-羟基异己酸以约0.15至约10g,优选约2g至约10g的量存在。该α-羟基异己酸还可以以约0.5g至约5g,更优选约2g至5g,最优选约1.5g的量存在。
在一个实施方案中,所述营养组合物包括ω-3脂肪酸源,其中ω-3脂肪酸源选自鱼油、磷虾、含有ω-3脂肪酸的植物源、亚麻仁、油菜油、核桃、藻类或其组合。所述ω-3脂肪酸选自α-亚麻酸(“ALA”)、十八碳四烯酸(SDA)、二十二碳六烯酸(“DHA”)、二十碳五烯酸(“EPA”)或其组合。
在一个实施方案中,所述营养组合物包括至少一种核苷酸,其选自脱氧核糖核酸(“DNA”)的亚基、核糖核酸(“RNA”)的亚基、DNA和RNA的聚合形式、酵母RNA,或其组合。所述至少一种核苷酸可以是外源核苷酸。可以以每天约0.5g至3g的量提供核苷酸。
在一个实施方案中,所述营养组合物包括这样的植物营养素,其选自黄酮类化合物(flavanoids)、同源的酚类化合物、多酚类化合物、萜类化合物、生物碱、含硫化合物,或其组合。所述植物营养素可选自类胡萝卜素、植物甾醇、槲皮素、姜黄素、柠檬苦素,或其组合。
在一个实施方案中,所述营养组合物包括蛋白质源。蛋白质源可为该营养组合物提供至少10g高质量蛋白质或提供每天至少10g的蛋白质量。所述蛋白质源可选自基于乳制品的蛋白质、基于植物的蛋白质、基于动物的蛋白质、人工蛋白质,或其组合。所述基于乳制品的蛋白质可选自酪蛋白、胶束酪蛋白、酪蛋白酸盐、酪蛋白水解物、乳清、乳清水解物、乳清浓缩物、乳清分离物、乳蛋白质浓缩物、乳蛋白质分离物,或其组合。所述基于植物的蛋白质选自大豆蛋白质、豌豆蛋白质、油菜蛋白质、小麦和分级分离的小麦蛋白质、玉米蛋白质、玉米醇溶蛋白、稻蛋白质、燕麦蛋白质、马铃薯蛋白质、花生蛋白质、青豆粉、菜豆粉、螺旋藻、来自蔬菜、豆类、荞麦、小扁豆、干豆(pulses)的蛋白质、单细胞蛋白质,或其组合。
在一个实施方案中,所述营养组合物包括这样的益生元,其选自阿拉伯胶、α-葡聚糖、阿拉伯半乳聚糖、β-葡聚糖、葡聚糖、低聚果糖、岩藻糖基乳糖(fucosyllactose)、低聚半乳糖、半乳甘露聚糖、低聚龙胆糖、低聚葡萄糖、瓜尔豆胶、菊粉、低聚异麦芽糖、乳新四糖(lactoneotetraose)、乳蔗糖、乳果糖、果聚糖、麦芽糖糊精、乳低聚糖、部分水解的瓜尔豆胶、果胶低聚糖(pecticoligosaccharides)、防腐的淀粉、老化淀粉、唾液酸低聚糖(sialooligosaccharides)、唾液酰基乳糖(sialyllactose)、大豆低聚糖、糖醇、低聚木糖、其水解产物,或其组合。
在一个实施方案中,所述营养组合物包括这样的益生菌,其选自气球菌属(Aerococcus)、曲霉菌属(Aspergillus)、拟杆菌属(Bacteroides)、双歧杆菌属(Bifidobacterium)、假丝酵母属(Candida)、梭菌属(Clostridium)、德巴利酵母属(Debaromyces)、肠球菌属(Enterococcus)、梭杆菌属(Fusobacterium)、乳杆菌属(Lactobacillus)、乳球菌属(Lactococcus)、明串珠菌属(Leuconostoc)、蜜蜂球菌属(Melissococcus)、微球菌属(Micrococcus)、毛霉菌属(Mucor)、酒球菌属(Oenococcus)、片球菌属(Pediococcus)、青霉属(Penicillium)、消化链球菌属(Peptostrepococcus)、毕赤酵母属(Pichia)、丙酸杆菌属(Propionibacterium)、Pseudocatenulatum、根霉菌属(Rhizopus)、酵母菌属(Saccharomyces)、葡萄球菌属(Staphylococcus)、链球菌属(Streptococcus)、球拟酵母菌属(Torulopsis)、魏斯氏菌属(Weissella)、非复制性微生物,或其组合。
在一个实施方案中,所述营养组合物包括这样的氨基酸,其选自丙氨酸、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、鸟氨酸、色氨酸、酪氨酸、缬氨酸,或其组合。在一个实施方案中,所述氨基酸是瓜氨酸。在一个实施方案中,所述氨基酸是选自异亮氨酸、亮氨酸、缬氨酸或其组合的支链氨基酸。
在一个实施方案中,所述营养组合物包括这样的抗氧化剂,其选自虾青素、类胡萝卜素、辅酶Q10(“CoQ10”)、黄酮类化合物、谷胱甘肽、Goji(枸杞)、橙皮苷、lactowolfberry、木酚素、叶黄素、番茄红素、多酚、硒、维生素A、维生素C、维生素E、玉米黄质,或其组合。
在一个实施方案中,所述营养组合物包括这样的维生素,其选自维生素A、维生素B1(硫胺素)、维生素B2(核黄素)、维生素B3(烟酸或烟酰胺)、维生素B5(泛酸)、维生素B6(吡哆醇、吡哆醛、或吡哆胺、或盐酸吡哆醇)、维生素B7(生物素)、维生素B9(叶酸),和维生素B12(多种钴胺素;通常是维生素补充剂中的氰钴胺素)、维生素C、维生素D、维生素E、维生素K、K1和K2(即,MK-4、MK-7)、叶酸、生物素、胆碱或其组合。
在一个实施方案中,所述营养组合物包括这样的矿物质,其选自硼、钙、铬、铜、碘、铁、镁、锰、钼、镍、磷、钾、硒、硅、锡、钒、锌,或其组合。
在一个实施方案中,所述营养组合物包括选自α-酮戊二酸、L-肉碱,或其组合的化合物。
在一个实施方案中,所述营养组合物是这样的形式,其选自片剂、胶囊剂、液体剂、咀嚼剂、软胶囊、囊剂、粉剂、糖浆剂、液体混悬剂、乳剂、溶液剂,或其组合。在一个实施方案中,所述营养组合物是粉剂的形式。
在一个实施方案中,所述营养组合物是口服营养补充剂、管饲液,或其组合。
在一个实施方案中,所述营养组合物是完全营养源。在另一实施方案中,所述营养组合物是不完全营养源。
在又一实施方案中,提供了用于在有其需要的个体中刺激肌肉蛋白质合成的方法。所述方法包括向个体施用包含有效量的α-羟基异己酸和有效量的瓜氨酸的营养组合物。
在仍又一实施方案中,提供了用于在有其需要的个体中使肌肉蛋白质分解代谢最小化的方法。所述方法包括向个体施用包含有效量的α-羟基异己酸和有效量的瓜氨酸的营养组合物。
在另一实施方案中,提供了用于在有其需要的个体中保持瘦体重的方法。所述方法包括向个体施用包含有效量的α-羟基异己酸和有效量的瓜氨酸的营养组合物。
在又一实施方案中,提供了用于在有其需要的个体中减少去负荷诱导的骨质流失的方法。所述方法包括向个体施用包含有效量的α-羟基异己酸和有效量的瓜氨酸的营养组合物。
在仍又一实施方案中,提供了用于在有其需要的个体中缓解骨骼肌萎缩的方法。所述方法包括向个体施用包含有效量的α-羟基异己酸和有效量的瓜氨酸的营养组合物。
在另一实施方案中,提供了用于在有其需要的个体中减轻高尿毒症负荷的方法。所述方法包括向个体施用包含有效量的α-羟基异己酸和有效量的瓜氨酸的营养组合物。
在一个实施方案中,所述个体选自老年人、具有医学状况的那些人,或其组合。
在一个实施方案中,向所述个体施用营养组合物,以为该个体提供每天约0.15至约10g,优选每天约2g至约10g,更优选每天约150mg至2.5g的α-羟基异己酸。还可向所述个体施用营养组合物,以为该个体提供每天约0.5g至约5g,更优选每天约2g至5g,或优选约1.5g。
在一个实施方案中,所述营养组合物包括瓜氨酸。可向所述个体施用营养组合物,以为该个体提供每天约1g至约15g的瓜氨酸,更优选每天约2g至约15g的瓜氨酸,甚至更优选每天约2g至约7g,甚至更优选约2g至约5g的瓜氨酸。还可向所述个体施用营养组合物,以为该个体提供每天约4g至约7g的瓜氨酸。
在一个实施方案中,所述营养组合物还包括这样形式的α-酮戊二酸,其选自鸟氨酸α-酮戊二酸盐、精氨酸α-酮戊二酸盐、酮异己酸(KIC)或其组合。可向所述个体施用营养组合物,以为该个体提供每天约2g至约20g的α-酮戊二酸。还可向所述个体施用营养组合物,以为该个体提供每天约10g至约30g的α-酮戊二酸。
在一个实施方案中,所述营养组合物还包括二十碳五烯酸。可向所述个体施用营养组合物,以为该个体提供每天约0.25g至约5g,更优选约250mg至约3g,甚至优选约250mg至1.5g的二十碳五烯酸。
在一个实施方案中,所述营养组合物还包括至少一种核苷酸,其选自脱氧核糖核酸(“DNA”)的亚基、核糖核酸(“RNA”)的亚基、DNA和RNA的聚合形式、酵母RNA,或其组合。所述至少一种核苷酸可以是外源核苷酸。
在一个实施方案中,所述营养组合物还包括选自亮氨酸、异亮氨酸、缬氨酸或其组合的至少一种支链氨基酸。
在一个实施方案中,所述营养组合物还包括L-肉碱。
本公开内容的优势是提供改良的营养组合物。
本公开内容的另一优势是提供使骨骼肌蛋白质合成最大化的营养组合物。
本公开内容的另一优势是提供使骨骼肌蛋白质的分解代谢最小化的营养组合物。
本公开内容的又一优势是提供保持瘦体重的营养组合物。
本公开内容的仍又一优势是提供帮助改善从体力活动恢复的营养组合物。
本公开内容的另一优势是提供帮助减少健康护理费用的营养组合物。
本公开内容的又一优势是提供帮助减少去负荷诱导的骨质流失的营养组合物。
本公开内容的仍又一优势是提供在有其需要的个体中帮助缓解骨骼肌萎缩的营养组合物。
本公开内容的另一优势是提供帮助减轻高尿毒症负荷的营养组合物。
本文描述了其他特征和优势,并且根据下文的详细描述将变得显而易见。
发明详述
如本文所用,“约”应该理解为表示数值的范围。此外,本文的所有数值范围应理解为包括范围内的所有整数、全部或分数。
如本文所用,术语α-羟基异己酸应理解为还包含α-羟基异己酸的类似物,如酮异己酸(KIC)。
如本文所用,术语“氨基酸”应理解为包括一种或多种氨基酸。所述氨基酸例如可以是丙氨酸、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、鸟氨酸或其组合。
如本文所用,“动物”包括,但不限于哺乳动物,其包括但不限于啮齿类、水生哺乳动物、家畜如狗和猫、农场动物如羊、猪、奶牛和马,以及人。其中使用术语“动物”或“哺乳动物”或其复数时,应理解为其还适用于能够通过该段落上下文显示或预期显示效果的任何动物。
如本文所用,术语“抗氧化剂”应理解为包括任何一种或多种不同的物质,如β-胡萝卜素(维生素A前体)、维生素C、维生素E和硒,其抑制由活性氧类别(“ROS”)和其他基团和非基团类别引发的氧化或反应。此外,抗氧化剂是能够减缓或预防其他分子氧化的分子。抗氧化剂的非限制性实例包括虾青素、类胡萝卜素、辅酶Q10(“CoQ10”)、黄酮类化合物、谷胱甘肽、枸杞、橙皮苷、lactowolfberry、木酚素、叶黄素、番茄红素、多酚、硒、维生素A、维生素C、维生素E、玉米黄质,或其组合。
如本文所用,“完全营养”包括这样的营养品和组合物,其含有足够类型和水平的大量营养素(蛋白质、脂肪和碳水化合物)和微量营养素,以足以成为所施用的动物的唯一营养源。患者可从此类完全营养组合物中获得100%的他们的营养需求。
如本文所用,“有效量”是预防不足、在个体中治疗疾病或医疗状况,或更一般地减轻症状、控制疾病的进程或为所述个体提供营养、生理或医学益处的量。治疗可以是患者或医生相关的。
尽管术语“个体”和“患者”在本文中经常用于指人,但本发明不限于此。因此,术语“个体”和“患者”指具有可从该治疗中受益的医学状况或存在医学状况风险的任何动物、哺乳动物或人。
如本文所用,ω-3脂肪酸源包括,例如鱼油、磷虾、ω-3的植物源、亚麻仁、油菜油、核桃,和藻类。ω-3脂肪酸的实例包括,例如,α-亚麻酸(“ALA”)、二十二碳六烯酸(“DHA”)、十八碳四烯酸(SDA)、二十碳五烯酸(“EPA”),或其组合。
如本文所用,“食物级微生物”表示所用的并且在食物使用中一般被认为是安全的微生物。
如本文所用,“不完全营养”包括这样的营养品或组合物,其不含有足够水平的大量营养素(蛋白质、脂肪和碳水化合物)和微量营养素,足以成为施用的动物的唯一营养源。部分或不完全营养组合物可用作营养补充剂。
如本文所用,“长期施用”优选为连续施用超过6周。或者,如本文所用,“短期施用”是连续施用小于6周。
如本文所用,“哺乳动物”包括,但不限于啮齿类、水生哺乳动物、家畜如狗和猫、农场动物如羊、猪、奶牛和马,以及人。其中使用术语“哺乳动物”时,应理解还适用于能够由哺乳动物显示或预期显示效果的其他动物。
术语“微生物”意在包括细菌、酵母和/或真菌、具有微生物的细胞生长培养基、或其中培养微生物的细胞生长培养基。
如本文所用,术语“矿物质”应理解为包括硼、钙、铬、铜、碘、铁、镁、锰、钼、镍、磷、钾、硒、硅、锡、钒、锌,或其组合。
如本文所用,“非复制性”微生物表示可以通过经典的平板培养方法检测无活细胞和/或菌落形成单位。在微生物书James Monroe Jay,等,“Modern food microbiology,”第7版,Springer Science,New York,N.Y.第790页(2005)中概括了此类经典的平板培养方法。通常,没有活细胞可显示如下:用接种不同浓度的细菌制剂(‘非复制性’样品)并在适当条件(需氧和/或厌氧气氛中至少24小时)温育后,在琼脂平板上没有可见的菌落或在液体生长培养基中没有增加的混浊度。例如,可通过热处理,特别是低温/长时间热处理致使双歧杆菌如长双歧杆菌(Bifidobacteriumlongum)、乳双歧杆菌(Bifidobacterium lactis)和短双歧杆菌(Bifidobacterium breve)或乳杆菌如副干酪乳杆菌(Lactobacillusparacasei)或鼠李糖乳杆菌(Lactobacillus rhamnosus)变成非复制性。
如本文所用,“正常的骨生长”指儿童和青少年骨通过塑造而成型的过程,其允许新骨在一个位置上形成并旧骨在同一骨里面从另一个位置上去除。该过程允许个体骨正常生长并移入适合空间。在儿童期,骨骼生长,因为在骨里面发生再吸收(破骨过程),同时在其外部(骨膜)表面上发生新骨骼的形成。在青春期,骨骼变得更厚,因为可在外部和内部(骨内膜)表面上发生形成。重建过程贯穿整个生命并且在骨达到其最高峰时(通常到二十几岁)变成主导过程。在重建中,去除骨小梁表面上或皮质内部中的少量骨,然后在相同位置上进行置换。所述重建过程不改变骨的形状,然而却对骨健康极其重要。塑造和重建持续贯穿整个生命,以致大多数成人骨骼每隔约10年置换一次。尽管重建在早期成年期占主导地位,但塑造可以特别是在应答骨退化时出现。
如本文所用,“核苷酸”应理解为脱氧核糖核酸(“DNA”)、核糖核酸(“RNA”)、聚合RNA、聚合DNA或其组合的亚基。其为由含氮碱基、磷酸分子和糖分子(DNA中的脱氧核糖和RNA中的核糖)组成的有机化合物。将单个核苷酸单体(单一单元)连接在一起,以形成聚合物或长链。饮食补充剂尤其提供外源核苷酸。所述外源核苷酸可以是单体形式,如例如,5'-腺苷一磷酸(“5'-AMP”)、5'-鸟苷一磷酸(“5'-GMP”)、5'-胞苷一磷酸(“5'-CMP”)、5'-尿苷一磷酸(“5'-UMP”)、5'-肌苷一磷酸(“5'-IMP”)、5'-胸苷一磷酸(“5'-TMP”),或其组合。所述外源核苷酸还可以是聚合形式,如例如完整的RNA。具有多种来源的聚合形式,如例如酵母RNA。
如本文所用,“营养品”或“营养组合物”应理解为包括任意数量的任选额外的成分,包括传统食品添加物(合成的或天然的),例如一种或多种酸化剂、额外的增稠剂、缓冲液或用于pH调节的试剂、螯合剂、着色剂、乳化剂、赋形剂、调味剂、矿物质、渗透剂、药学上可接受的载体、防腐剂、稳定剂、糖、增甜剂、组织形成剂(texturizers),和/或维生素。可以以任何合适的量加入任选成分。所述营养品或组合物可以是完全营养的来源或可以是不完全营养的来源。
如本文所用,术语“患者”应理解为包括动物,尤其是哺乳动物,并更尤其是接受或预期接受治疗的人,如本文所定义。
如本文所用,“植物化学物”或“植物营养素”是在许多食物中发现的非营养化合物。植物化学物是具有除基本营养外的健康益处的功能性食物,是来自植物来源的促进健康的化合物,并且可以是天然的或纯化的。“植物化学物”和“植物营养素”指植物产生的任何化学品,其赋予使用者一种或多种健康益处。植物化学物和植物营养素的非限制性实例包括下面那些:
i)酚类化合物,其包括单苯酚(例如:芹菜脑、鼠尾草酚、香芹酚、莳萝脑、Rosemarinol);类黄酮(多酚),包括黄酮醇(例如:槲皮素、姜醇、堪非醇、杨梅树皮素、芦丁、异鼠李黄素)、黄烷酮类(例如:桔皮苷、柚皮素、水飞蓟素、圣草素)、黄酮(例如:芹菜配基、柑桔黄酮、毛地黄黄酮)、黄烷-3-醇(例如:儿茶素、(+)-儿茶素、(+)-没食子儿茶精、(-)-表儿茶酸、(-)-表没食子儿茶精(epigallocatechin)、(-)-表没食子儿茶精没食子酸酯(EGCG)、(-)-表儿茶酸3-没食子酸酯、茶黄素、茶黄素-3-没食子酸酯、茶黄素-3′-没食子酸酯、茶黄素-3,3′-二没食子酸酯、茶玉红精(thearubigin))、花色素苷(flavonals)和花色素(例如:花葵素、甲基花青素、花青素、翠雀素、二甲翠雀素、矮牵牛苷配基)、异黄酮(植物雌激素)(例如:大豆黄素(芒柄花素)、染料木黄酮(鸡豆黄素A)、黄豆黄素)、二氢黄酮醇(dihydroflavonol)、查耳酮、考米斯坦(coumestans)(植物雌激素)和香豆雌酚;酚酸(例如:鞣花酸、没食子酸、鞣酸、香草醛、姜黄素);羟基肉桂酸(例如:咖啡酸、氯原酸、肉桂酸、阿魏酸、香豆素)、木酚素(植物雌激素)、水飞蓟素、开环异落叶松脂素(secoisolariciresinol)、松脂醇和落叶松树脂醇(lariciresinol);酪醇酯(tyrosol esters)(例如:酪醇、羟基酪醇、橄榄油刺激醛(Oleocanthal)、橄榄苦苷);芪类化合物(stilbenoids)(例如:白藜芦醇、蝶芪、白皮杉醇(Piceatannol))和安石榴苷(punicalagin);
萜烯(类异戊二烯),其包括类胡萝卜素(四聚类萜)包含胡萝卜素(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:角黄素、隐黄素、玉米黄素、虾青素、黄体素、玉红黄质);单萜(例如:柠檬烯、紫苏子醇(perillyl alcohol));皂苷;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)和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、模绕酮酸(moronic acid));
iii)甜菜红碱(betalain),其包括β花青苷(betacyanin)(例如:甜菜苷、异甜菜甙、probetanin、新甜菜甙(neobetanin))和甜菜黄素(betaxanthin)(非糖苷型)(例如:梨果仙人掌黄质和仙人掌黄素(vulgaxanthin));
iv)有机硫化物,其包括二硫酚硫酮(异硫氰酸酯)(例如:莱菔子素(Sulphoraphane));和Thiosulphonate(葱属化合物)(例如:烯丙基甲基三硫化物和二烯丙基硫醚)、吲哚类、硫代葡萄糖酸盐(glucosinolate),其包括吲哚-3-甲醇;莱菔硫烷(sulforaphane);3,3′-二吲哚基甲烷;黑芥子苷;蒜素;蒜氨酸;异硫氰酸烯丙酯;胡椒碱;顺式-丙硫醛(propanethial)-S-氧化物;
v)蛋白质抑制剂,其包括,例如蛋白酶抑制剂;
vi)其他有机酸,其包括草酸、植酸(六磷酸肌醇酯);酒石酸;和漆树酸;或者
vii)它们的组合。
作为本说明书和待批权利要求中所用的,除非另有清楚地表述,否则单数形式“一种(a)”、“一种(an)”和“该(the)”包括复数指示物。因此,例如,所涉及的“多肽”包括两种或多种多肽类的混合物等。
本文所用的“益生元”是食品物质,其选择性地促进肠中有益菌生长或抑制肠中致病菌生长或粘膜粘着。它们在摄入其的人体的胃和/或上肠中失活或在胃肠道中吸收,但它们被胃肠微生物群落和/或益生菌发酵。例如,益生元由Glenn R.Gibson和Marcel B.Roberfroid在“Dietary Modulationof the Human Colonic Microbiota:Introducing the Concept of Prebiotics,”J.Nutr.,125:1401-1412(1995)中定义。益生元的非限制性实例包括阿拉伯胶、α葡聚糖、阿拉伯半乳聚糖、β-葡聚糖、右旋糖酐类、果糖寡聚体、墨角藻糖基乳糖、半乳糖低聚糖、半乳糖甘露聚糖、龙胆低聚糖、葡萄糖低聚糖、瓜尔胶、菊粉、异麦芽糖寡糖、lactoneotetraose、乳果糖、乳果糖、果聚糖、麦芽糖糊精、乳寡糖类、部分水解的瓜尔胶、果胶寡糖类、防腐的淀粉、老化淀粉、唾液酰寡糖类、唾液酰乳糖、大豆寡糖类、糖醇类、木寡糖类或其水解物或它们的组合。
本文所用的益生菌微生物(下文的“益生菌”)是食品级微生物(活的,包括半活的或弱的和/或无复制的)、代谢物、微生物细胞制品或微生物细胞成分,它们在以足量施用时可以对宿主提供健康有益性,更具体地,是通过改善其肠微生物平衡有益地影响宿主,导致对宿主健康或健康幸福产生效果。参见Salminen S,Ouwehand A.Benno Y.等人“Probiotics:howshould they be defined?,”Trends Food Sci.Technol.,10,107-10(1999)。一般而言,认为这些微生物抑制或影响肠道中的致病菌生长和/或代谢。益生菌还可以激活宿主的免疫功能。由于这一原因,所以存在许多不同的方法以将益生菌包括入食品。益生菌的非限制性实例包括气球菌属(Aerococcus)、曲霉属(Aspergillus)、拟杆菌属(Bacteroides)、双歧杆菌属(Bifidobacterium)、假丝酵母属(Candida)、梭菌属(Clostridium)、德巴利酵母属(Debaromyces)、肠球菌属(Enterococcus)、梭杆菌属(Fusobacterium)、乳杆菌属(Lactobacillus)、乳球菌属(Lactococcus)、明串珠菌属(Leuconostoc)、蜜蜂球菌属(Melissococcus)、微球菌属(Micrococcus)、毛霉属(Mucor)、酒球菌属(Oenococcus)、片球菌属(Pediococcus)、青霉属(Penicillium)、消化链球菌属(Peptostrepococcus)、毕赤酵母属(Pichia)、丙酸杆菌属(Propionibacterium)、假链状菌属(Pseudocatenulatum)、根霉属(Rhizopus)、酵母属(Saccharomyces)、葡萄球菌属(Staphylococcus)、链球菌属(Streptococcus)、球拟酵母属(Torulopsis)、魏斯氏菌属(Weissella)或它们的组合。
本文所用的术语“蛋白质”、“肽”、“寡肽类”或“多肽”应理解为是指任意的组合物,其包括单一氨基酸(单体)、两种或多种彼此通过肽键结合的氨基酸(二肽、三肽或多肽)、胶原蛋白、前体、同源物、类似物、模拟物、盐、前体药物、代谢物或其片段或它们的组合。为清楚起见,除非另有指定,否则任意上述术语的应用可互换。可以理解多肽类(或肽类或蛋白质或寡肽类)通常包含这样的氨基酸,其不是常称作20种天然存在的20种氨基酸的氨基酸,包括末端氨基酸,可以通过天然方法例如本领域技术人员众所周知的糖基化和其他翻译后修饰或通过化学修饰技术将它们修饰成指定的多肽。在可以存在于本发明多肽中的已知修饰中包括、但不限于乙酰化、酰化、ADP-核糖基化、酰胺化、类黄酮或血红素部分的共价结合、多核苷酸或多核苷酸衍生物的共价结合、脂质或脂质衍生物的共价结合、磷脂酰肌醇的共价结合、交联、环化、二硫键形成、去甲基化、共价交联形成、胱氨酸形成、焦谷氨酸形成、甲酰化、-羧化、糖化、糖基化、糖基磷脂酰肌醇(“GPI”)膜锚定形成、羟基化、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、硫酸化、转移-RNA介导的氨基酸添加到多肽类上例如精氨酰化和遍在蛋白化。术语“蛋白质”还包括“人造蛋白”,其指的是直链或非直链多肽类,它们由肽的交替重复单元组成。
蛋白质的非限制性实例包括基于乳制品的蛋白质、基于植物的蛋白质、基于动物的蛋白质和人工蛋白质。所述基于乳制品的蛋白质可选自酪蛋白、胶束酪蛋白、酪蛋白酸盐、酪蛋白水解物、乳清、乳清水解物、乳清浓缩物、乳清分离物、乳蛋白质浓缩物、乳蛋白质分离物,或其组合。基于植物的蛋白质包括例如大豆蛋白质(例如,所有形式,包括浓缩物和分离物)、豌豆蛋白质(例如,所有形式,包括浓缩物和分离物)、油菜蛋白质(例如,所有形式,包括浓缩物和分离物),可商购的其他植物蛋白质是小麦和分级分离的小麦蛋白质、玉米和其级分包括玉米醇溶蛋白质、稻、燕麦、马铃薯、花生以及衍生自豆、乔麦、小扁豆、干豆的任何蛋白质、单细胞蛋白质或其组合。基于动物的蛋白质可以选自牛肉、家禽肉、鱼肉、羊肉、海鲜或其组合。
本申请书中包括的所有剂量范围旨在包括所述范围内包括的所有数值,全部或分数。
如本文所用,“合生素”是指含有益生元和益生菌的补充剂,它们一起起作用改善肠道的微生物区系。
本文所用的术语“治疗”和“缓解”包括预防或预防性治疗(预防和/或减缓靶向病理学情况或障碍发生)和治愈、治疗或改善疾病的治疗,包括为治愈、减慢、减轻诊断的病理学情况或障碍症状和/或阻止其进展的治疗措施;和治疗染病或怀疑具有染病的风险中的患者和疾病或诊断为患有疾病或医学病症的患者。该术语不一定意味着受试者受到治疗至恢复。术语“治疗”还指维持和/或促进未患疾病、但可能倾向于发生不健康情况例如氮失衡或肌肉缺失的个体健康。术语“治疗”和“缓解”还预以包括强化、否则就是增强一种或多种主要的预防或治疗措施。术语“治疗”和“缓解”还预以包括疾病或病症的膳食处置或用于预防或防止疾病或病症的膳食处置。
本文所用的“管饲液”是全或不完全营养产品或组合物,其施用于动物胃肠系统,而不是通过口服施用,包括、但不限于经鼻胃管、口胃管、胃管、空肠造口术管(“J-管”)、经皮内镜胃造瘘术(“PEG”)、口例如提供胃、空肠的入口的胸壁口和其他适合的入口。
本文所用的术语“维生素”应理解为包括任意各种脂溶性或水溶性有机物(非限制性实例包括维生素A、维生素B1(硫胺)、维生素B2(核黄素)、维生素B3(烟酸或烟酰胺)、维生素B5(泛酸)、维生素B6(吡多辛、吡哆醛或吡哆胺或吡多辛的盐酸盐)、维生素B7(生物素)、维生素B9(叶酸)和维生素B12(各种钴胺类;在维生素补充剂中常用氰钴胺)、维生素C、维生素D、维生素E、维生素K、K1和K2(即MK-4,MK-7)、叶酸和生物素),其用量微小用于正常身体生长和活动,并且天然得自植物和动物食物或合成方式制备的前维生素、衍生物、胆碱、类似物。
本公开内容涉及具有营养素和食物成分的组合的营养组合物,以使肌肉蛋白质合成最大化,同时使肌肉蛋白质的分解代谢最小化,以便尽可能保持患者(包括,例如老年人和患有疾病的那些人)的瘦体重。
本公开内容的营养组合物包括α-羟基异己酸(“HICA”),其组合有其他化合物,以使肌肉组织的合成代谢最大化并使其分解代谢最小化。申请人已经发现,由于具有更好的味觉谱(提高柔软度,并因此提高功效)以及互补的代谢益处,与α-HICA的多种组合递送了较好的益处。例如,α-HICA是具有直接与蛋白质合成相关的代谢益处的亮氨酸代谢物,而其他化合物,如瓜氨酸递送辅助合成代谢过程的益处。
骨骼肌蛋白质合成的翻译控制包括起始、延伸和终止处的控制点。除涉及信使核糖核酸(“mRNA”)与40S核糖体亚基结合的翻译起始步骤外,调节可通过调整起始子甲硫氨酰-tRNA(“met-tRNAi”)与40S核糖体亚基的结合而发生,以形成43S起始前复合物。在此步骤中,eIF2–GTP–met-tRNAi复合物结合40S核糖体亚基,以形成三元复合物。结合eIF2的鸟苷三磷酸(“GTP”)随后被水解成鸟苷二磷酸(“GDP”),并且eIF2–GDP复合物从所述40S核糖体亚基释放。然后eIF2必须把GDP换成GTP,以参与下一轮的起始并形成新的三元复合物。第二种翻译起始因子eIF2B介导eIF2上的鸟苷酸交换,并且抑制eIF2B的活性减少了可用于形成三元复合物的eIF2-GTP的量。在某种程度上,eIF2B的活性受eIF2的α亚基磷酸化的调节,当在α亚基上被磷酸化时,其变成eIF2B的竞争性抑制剂。此外,α-HICA通过eIF2B活性增加和三元复合物形成而增强的翻译效率来介导其对总体蛋白质合成的急性作用。
可以以一个大丸剂或几次更小的剂量向个体或患者提供本公开内容的营养组合物。然而,本公开内容的营养组合物应该为所述个体提供每天约0.15至约10g,优选每天约2g至约10g,更优选每天约150mg至约2.5g的α-羟基异己酸的α-HICA量。在一个实施方案中,为该个体提供每天约0.5g至约5g,更优选每天约2g至5g,甚至更优选1.5g的α-HICA。
在一个实施方案中,向个体施用所述营养组合物,以为所述个体提供约。还可向该个体施用所述营养组合物,以为所述个体提供约。
在一个实施方案中,本公开内容的营养组合物包括α-HICA和瓜氨酸。瓜氨酸是仅在西瓜(Citrullus lanatus)中以巨大膳食量发现的非蛋白质氨基酸。摄入瓜氨酸可导致多胺的形成。已经报道多胺,如胍基丁胺、腐胺、亚精胺和精胺参与多种生理学和生物化学现象,包括蛋白质激酶C(“PKC”)、胞外信号调节的激酶(“ERK”)和转化生长因子β1(“TGF-β1”)的上调。
瓜氨酸的代谢命运是转化成精氨酸。实际上,瓜氨酸在提高血清精氨酸上非常有效,所述血清精氨酸是体内一氧化氮(“NO”)的来源。NO对舒张血管并向身体组织中递送血流是重要的。血流改善后,血液中的营养素和其他化合物可以更有效地被递送到骨骼肌组织。此外,NO是用于刺激蛋白质合成和释放生长因子(如上文提及的多胺)的合成代谢信号和促进剂。NO还导致胰岛素和IGF-1的释放,导致合成代谢底物的增强吸收以及底物的生物利用。
Guadagni和Biolo指出,具有炎症的个体(如老年人或患有疾病的个体)中可能需要额外的蛋白质,以部分维持精氨酸和谷氨酰胺的水平。参阅,Guadagni和Biolo,Effects of inflammation and/or inactivity on theneed for dietary protein,第12卷,第6期,第617-622页(2009)。瓜氨酸可作用于维持精氨酸水平。此外,其可帮助维持谷氨酰胺水平,因为来自外源提供的瓜氨酸的反馈信号将减少小肠中谷氨酰胺至瓜氨酸的转化。这将减少进行肌肉分解代谢以为躯体功能提供精氨酸和谷氨酰胺的需求。
还可能的是,α-HICA与瓜氨酸的组合将协同改善老年人瘦体重的维持,所述老年人进行有限量的运动和/或物理治疗。已经显示瓜氨酸在营养不良的年老动物中具有合成代谢作用。老年人群体中的合成代谢信号通常是下调的。α-HICA和瓜氨酸的添加将为该信号提供强的加强作用。这种从体力活动改善的恢复将允许从由于疾病或创伤而从而被迫静止中加速恢复。基于减少数量的物理治疗阶段和更快回到完全独立的生活并返回工作,还可以实现护理费用的减少。
如上文所提及,可以以一个大丸剂或几次更小的剂量向个体或患者提供本公开内容的营养组合物。然而,本公开内容的营养组合物应该为个体提供每天约1g至约15g的瓜氨酸,更优选每天约2g至约15g的瓜氨酸,甚至更优选每天约2g至约7g,甚至更优选约2g至约5g的瓜氨酸的量。在一个实施方案中,为所述个体提供每天约4g至约7g的瓜氨酸。
本公开内容的营养组合物还可包括α-HICA和α-酮戊二酸(“AKG”)(其为谷氨酰胺的前体)的协同组合。在施用脂多糖(“LPS”)对小猪施压的小猪模型中,AKG增加了肠内雷帕霉素的哺乳动物靶标(“mTOR”)的磷酸化,导致蛋白质合成和抗炎症应答增加。同样,AKG增加了绒毛高度并减少了隐窝深度,并因而具有增加吸收能力(氨基酸的增强吸收)的可能。申请人已经发现,包括α-HICA和AKG的营养组合物的这些可能益处(例如,氧化损伤,吸收)可导致营养素递送增强,促进特别是炎症状况中进一步的合成代谢。
如上文所提及,可以以一个大丸剂或几次更小的剂量向个体或患者提供本公开内容的营养组合物。然而,本公开内容的营养组合物应该为所述个体提供每天约2g至约20g的α-酮戊二酸或每天约10g至30g的AKG量。所述AKG可以是鸟氨酸AKG、精氨酸AKG,或其组合的形式。
加入外源核苷酸可通过两种机制使得AKG更有效:(i)通过减少使用谷氨酰胺在肠道中产生核苷酸来维持AKG水平,和(ii)利用核苷酸增强维持如先前研究中显示的绒毛高度。由于营养不良或仅与年龄增长相关的减少的一般合成代谢,核苷酸提供的肠健康在老年人中尤为重要。
已知支链氨基酸(“BCAA”)是必需的(indispensible)氨基酸。必须外源提供BCAA以及其他必需氨基酸,以允许肌肉蛋白质合成。BCAA,尤其是亮氨酸还可用作信号分子,以刺激肌肉蛋白质合成。这可以通过两种机制。第一种机制是刺激胰岛素释放,因为亮氨酸是强的促分泌素。第二种机制更直接,因为亮氨酸可刺激开启肌肉蛋白质合成的真核诱导因子。
在任何制剂中提供所有三种BCAA(即,亮氨酸、异亮氨酸和缬氨酸)是重要的,因为一种BCAA的大量增加可引起其他两种BACC的相对缺乏。因为BCAA以其不希望的感觉谱出名,添加类似物如α-HICA以及designer或高质量蛋白质如,例如乳清蛋白质胶束是递送益处的有效途径,同时提高患者的依从性,并因而改善临床结果,得到更好的生活质量以及健康经济优势。此外,与免疫调节剂如lactowolfberry的组合可为具有轻度炎症、抑制的合成代谢和免疫衰老的患者(例如,老年人或患有疾病的那些人)带来协同益处。
在另一实施方案中,本公开内容的营养组合物可包括α-HICA和ω-3脂肪酸。ω-3脂肪酸的实例包括例如,括二十二碳六烯酸(“DHA”)、二十碳五烯酸(“EPA”)和α-亚麻酸(“ALA”)。已经显示,EPA(ω-3多不饱和脂肪酸)通过使核因子-κβ(“NF-κβ”)的激活最小化的常见细胞信号途径来缓解癌恶病质以及脓毒症中的骨骼肌萎缩,并减少去负荷诱导的骨质流失。申请人已经发现,具有α-HICA和EPA的营养组合物通过靶向抑制NFkβ衰减丢失瘦体重和骨矿物质密度来协同影响肌肉骨骼的健康。此外,α-HICA和EPA可分别在分解代谢、废用和老化条件下增强骨骼肌蛋白质合成(如通过mTOR途径介导)并减少内源肌肉蛋白水解(如通过遍在蛋白-蛋白酶体途径介导)。营养治疗将产生保持的瘦体重,其将向下面的骨提供增强的负荷并作为成骨刺激物起作用,用于骨更新并减小骨折风险。
瘦体重提高的保持将帮助维持代谢稳态和功能灵活性。此外,骨量密度的保持将减少骨折的风险,因此导致生活质量提高以及健康护理费用节省。
可以以一个大丸剂或几次更小的剂量向个体或患者提供本公开内容的营养组合物。然而,本公开内容的营养组合物应该为所述个体提供每天约0.25g至约5g,更优选约250mg至约3g,甚至更优选约250mg至1.5g二十碳五烯酸的EPA量。在一个实施方案中,为所述个体提供每天约750mg的EPA。
可通过(i)包装(例如,提供UV-屏障和/或O2清除内层);(ii)制备(例如,提供无菌生产,减少“顶部空间”,并减少热暴露),和(iii)封装含有α-HICA和EPA的脂质乳液(例如,在制备和初始消化过程中保护组合物)改善具有α-HICA和EPA的营养组合物的递送和生物利用率。此外,EPA的素食源提供了具有改善的感官特性的长链多不饱和脂肪酸(“LC-PUFA”)的可持续源。
本公开内容的营养组合物可提供有效量的α-HICA,以防止肌肉萎缩。肌肉萎缩在患有慢性肾病的个体中通常值得注意。然而,申请人已经发现向肾病患者部分应用α-HICA具有若干益处。例如,向肾病患者部分施用具有α-HICA的营养组合物可提供氮或蛋白质节约效应并在慢性肾衰竭,尤其在显示尿毒症的患者中改善氮平衡。支链α-酮酸和α-HICA可从尿毒症患者的升高的含氮环境中吸收胺基团,并因此减少整体氮负荷。该取代还部分地减少患者的总蛋白质摄入,由此在尿毒症患者中减少氮负荷的进一步增加,其减轻与升高的尿素水平相关的毒性。通过利用α-HICA和/或其他酮酸进行取代提供部分蛋白质需求可提高患者的总蛋白质摄入,其支持肌肉蛋白质。
此外,像其前体亮氨酸,α-HICA可刺激肌肉蛋白质合成和/或限制肌肉蛋白质分解,这对该患者群体有益。美国专利号4,752,619支持上述产品在与20-30g/天混合质量蛋白质饮食,和微生物及矿物质补充剂的结合中的用途。
申请人还已经惊奇地发现,具有α-HICA和L-肉碱组合的本公开内容的营养组合物在慢性肾病患者,并且尤其在遭受尿毒症的患者中展示协同作用。L-肉碱是在肝和肾中从氨基酸赖氨酸和甲硫氨酸生物合成的季铵化合物。发现其在肾病中不足,这是由于透析患者中由透析引起的受损的生物合成、减少的蛋白质摄入和损失。L-肉碱补充剂在肾病患者中的益处可包括促红细胞生成素抗性贫血、肌肉症状、心脏性能和功能能力的改善、还可支持肌肉功能的益处。α-HICA和L-肉碱的组合将提供在某种程度上减少尿毒症负荷,同时提供至少部分支持肌肉功能的贫乏产物L-肉碱的双重益处,这是由于其作为长链脂肪酸到达线粒体的转运子用于产能氧化的主要功能。
用于老年人和具有不足的肌肉合成代谢和过量的肌肉分解代谢的患者的现有营养支持溶液缺少功效。此外,在老年人个体中,存在显著的瘦体重丧失,导致独立性、功能性和生活质量的丧失。此外,老年人患者的认知能力下降,并且与这些发病相关的健康护理费用高。对瘦体重丧失的常规应答已经为患者提供了增加水平的蛋白质。
申请人已经发现,额外有益成分的使用允许更有效地使用所施用的蛋白质,用于保持瘦体重。因此,本公开内容的营养组合物通过增加肌肉合成代谢同时减少肌肉分解代谢来改善老年人个体或具有肌肉丧失风险(例如少肌症、恶病质、固定)的患者中的瘦体重的保持。可将提供增加合成代谢和降低分解代谢益处的成分掺入到适合通过口腔或管饲施用来完全喂养的口服补充剂和完全喂养产品。还可将本公开内容的营养组合物装配并包装成粉剂,用于在使用时溶解。
在其中营养组合物是口服补充剂的实施方案中,所述补充剂可含有活性成分加含有10克或更多克高质量蛋白质的适当营养谱,其可作为乳清蛋白质胶束、具有EPA和DHA的脂质,和碳水化合物提供用于能量和风味。还可包括维生素如维生素D和矿物质和成分如lactowolfberry,以及核苷酸。
完全喂养产品可具有维持生活所必需的全部营养素加上增强的合成代谢和降低的分解代谢所必需的活性成分(例如,α-HICA和/或其他有益成分如L-肉碱、瓜氨酸、AKG、EPA等)。
可以通过任意适合于人体施用且特别是为胃肠道任意部分施用的任意方式施用本说明书的营养组合物。肠施用、口服施用和通过管或导管施用均被本说明书所覆盖。还可以通过选自口服、直肠、舌下、唇下、口含、局部等的方式施用该营养组合物。
如果配制用于口服施用的营养组合物,则该组合物可以是液体口服营养补剂(例如不完全饲喂剂)或完全饲喂剂。按照这种方式,可以任意公知的形式施用营养组合物,包括,例如,便利剂型的片剂、胶囊、液体、咀嚼片、软胶囊、小药囊、粉剂、糖浆剂、液体混悬液、乳剂和溶液。在软胶囊中,优选将活性成分溶于或混悬于适合的液体,例如脂肪油、石蜡油或液体聚乙二醇。任选地,可以加入稳定剂。
本说明书的适合的营养组合物形式包括,例如婴儿配方、溶液、方便消费的组合物(例如方便饮料组合物或速溶饮料)、液体食品、软饮料、果汁、运动饮料、乳品饮料、冷冻牛奶、酸乳饮料、汤等。在另一个实施方案中,可以制备营养组合物并且以浓缩物、粉末或颗粒(例如泡腾颗粒)形式销售,将它们用水或其他液体例如乳品或果汁稀释,得到方便消费的组合物(例如方便饮料组合物或速溶饮料)。
营养组合物还可以包括ω-3和/或ω-6脂肪酸源。ω-3脂肪酸源的实例包括,例如鱼油、磷虾、ω-3的植物来源、亚麻子、胡桃和藻类。ω-3脂肪酸的非限制性实例包括α-亚麻酸(“ALA”)、二十二碳六烯酸(“DHA”)、十八碳四烯酸(SDA)和二十碳五烯酸(“EPA”)。ω-6脂肪酸的非限制性实例包括亚油酸(“LA”)、花生四烯酸(“ARA”)。
在优选的实施方案中,以每天约0.25g至5.0g,优选每天约1.0至3.0g的量提供所述ω-3脂肪酸。
在一个实施方案中,营养组合物包括植物化学品源。植物化学品是在许多水果和蔬菜等食物中发现的非营养性化合物。一般可以将数以千计的植物化学品分类成三个主要组。第一组是类黄酮和同源的酚类化合物和多酚类化合物。第二组是萜类化合物,例如类胡萝卜素类和植物甾醇类。第三组是生物碱类和含硫的化合物。植物化学品在体内具有活性,一般而言,以与抗氧化剂类似地其作用。它们还显然地在炎症过程、血块形成、哮喘和糖尿病中起有益作用。
在一个实施方案中,营养组合物包括蛋白质源。所述蛋白质源可以是膳食蛋白,包括、但不限于动物蛋白(例如乳蛋白、肉蛋白或卵蛋白)、植物蛋白(例如大豆蛋白、小麦蛋白、稻米蛋白和豌豆蛋白)或它们的组合。在一个实施方案中,蛋白质选自乳清、鸡肉、玉米、酪氨酸盐、小麦、亚麻、大豆、角豆胶、豌豆或它们的组合。
在一个实施方案中,包括植物蛋白以进一步增强配方中净碱性物质的分布和增加大量营养物源种类。基于具体植物蛋白(例如豌豆蛋白分离物)营养特性,对可以包括在配方中的植物蛋白源的量有限制。例如,豌豆蛋白的氨基酸分布包括所有必不可少的氨基酸。豌豆蛋白相对地富含精氨酸,但在含硫的氨基酸甲硫氨酸和半胱氨酸中有限。然而,例如,能够将豌豆蛋白分离物与具有足够含硫的氨基酸的全白质源掺合(例如乳蛋白或全植物蛋白)以补偿这种缺乏。芸苔蛋白(即分离物、水解物和浓缩物)是一种这样的植物蛋白,其可以提供适量的含硫的氨基酸以进一步增加氨基酸分布,从而为患者递送必需的蛋白质质量。另外,动物来源的蛋白质典型地比植物蛋白质更富含含硫的氨基酸。
本说明书的营养组合物还可以包括碳水化合物源。任意适合的碳水化合物可以用于本发明的营养组合物,包括、但不限于蔗糖、乳糖、葡萄糖、果糖、玉米糖浆固体、麦芽糖糊精、改性淀粉、直链淀粉、木薯淀粉、玉米淀粉或它们的组合。
营养组合物还可以包括谷物。所述谷物可以包括,例如可以获自不同来源的全谷物。不同的来源可以包括粗面粉、松果、粗碾玉蜀黍、面粉和微粉化谷物(微粉化面粉)且可以来源于谷类或假谷类。在一个实施方案中,所述谷物是水解全谷物成分。本文所用的“水解全谷物成分”是酶促消化的全谷物成分或通过使用至少一种阿法淀粉酶消化的全谷物成分,所述的阿法淀粉酶在活性状态下对膳食纤维不显示水解活性。可以通过使用蛋白酶进一步消化水解全谷物成分,所述蛋白酶在活性状态下对膳食纤维不显示水解活性。水解全谷物成分可以以液体、浓缩物、粉末、果汁、菜泥或它们的组合形式提供。
本发明营养组合物中还可以包括脂肪源。脂肪源可以包括任意适合的脂肪或脂肪混合物。例如,脂肪源可以包括、但不限于植物脂肪(例如橄榄油、玉米油、向日葵油、高油酸向日葵、亚麻子油、菜籽油、油菜油、高油酸油菜油、榛子油、大豆油、棕榈油、椰子油、黑醋栗种子油、琉璃苣油、卵磷酯类等)、动物脂肪(例如乳脂)或它们的组合。脂肪源还可以是上述举出的脂肪的精制度较低形式(例如多酚内含物的橄榄油)。
在一个实施方案中,营养组合物还包括一种或多种益生元。益生元的非限制性实例包括阿拉伯胶、α葡聚糖、阿拉伯半乳聚糖、β-葡聚糖、右旋糖酐类、果糖寡聚体、墨角藻糖基乳糖、半乳糖低聚糖、半乳糖甘露聚糖、龙胆低聚糖、葡萄糖低聚糖、瓜尔胶、菊粉、异麦芽糖寡糖、lactoneotetraose、乳果糖、乳果糖、果聚糖、麦芽糖糊精、乳寡糖类、部分水解的瓜尔胶、果胶寡糖类、防腐的淀粉、老化淀粉、唾液酰寡糖类、唾液酰乳糖、大豆寡糖类、糖醇类、木寡糖类、其水解物或它们的组合。
营养组合物还可以包括一种或多种益生菌。益生菌的非限制性实例包括气球菌属(Aerococcus)、曲霉属(Aspergillus)、拟杆菌属(Bacteroides)、双歧杆菌属(Bifidobacterium)、假丝酵母属(Candida)、梭菌属(Clostridium)、德巴利酵母属(Debaromyces)、肠球菌属(Enterococcus)、梭杆菌属(Fusobacterium)、乳杆菌属(Lactobacillus)、乳球菌属(Lactococcus)、明串珠菌属(Leuconostoc)、蜜蜂球菌属(Melissococcus)、微球菌属(Micrococcus)、毛霉属(Mucor)、酒球菌属(Oenococcus)、片球菌属(Pediococcus)、青霉属(Penicillium)、消化链球菌属(Peptostrepococcus)、毕赤酵母属(Pichia)、丙酸杆菌属(Propionibacterium)、假链状菌属(Pseudocatenulatum)、根霉属(Rhizopus)、酵母属(Saccharomyces)、葡萄球菌属(Staphylococcus)、链球菌属(Streptococcus)、球拟酵母属(Torulopsis)、魏斯氏菌属(Weissella)、无复制微生物或它们的组合。
一种或多种氨基酸也可以存在于营养组合物中。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、缬氨酸或它们的组合。
在优选的实施方案中,可以以每天约10g至40g的量提供谷氨酰胺。
一种或多种抗氧化剂也可以存在于营养组合物中。抗氧化剂的非限制性实例包括虾青素、类胡萝卜素、辅酶Q10(“CoQ10”)、类黄酮、谷胱甘肽、枸杞子(薄叶西方雪果)、桔皮苷、lactowolferry、木酚素、叶黄素、番茄红素、多酚、硒、维生素A、维生素C、维生素E、玉米黄素或它们的组合。
营养组合物还包括纤维或不同类型纤维的掺合物。所述纤维掺合物可以包含可溶性和不溶性纤维的混合物。可溶性纤维可以包括,例如果糖寡聚体、阿拉伯胶、菊粉等。不溶性纤维可以包括,例如豌豆外纤维。
本说明书的营养组合物可以是不完全或全营养物来源。可以通过口服施用或管饲施用营养组合物。如果配制用于口服施用的营养组合物,则该组合物可以是液体口服营养补剂或饲喂液。营养组合物还可以用于短期或长期管饲。
在仍另一实施方案中,提供施用本公开内容的营养组合物的方法。例如,在一个实施方案中,提供用于在有其需要的个体中刺激肌肉蛋白质合成的方法。在另一实施方案中,提供用于在有其需要的个体中使肌肉蛋白质的分解代谢最小化的方法。在仍另一实施方案中,提供用于在有其需要的个体中保持瘦体重的方法。在仍又一实施方案中,提供用于在有其需要的个体中减少去负荷诱导的骨质流失的方法。在仍另一实施方案中,提供用于在有其需要的个体中缓解骨骼肌萎缩的方法。在另一实施方案中,提供用于在有其需要的个体中减轻高尿毒症负荷的方法。所述方法包括向个体施用包含有效量的α-羟基异己酸的营养组合物。本公开内容的营养组合物还可以包括如上文讨论的其他活性或非活性成分。
应理解,本文所述的目前优选的实施方案的各种改变和变型对本领域技术人员而言显而易见。可以在不脱离本发明主题和不减少其指定优点的情况下进行这种改变和变型。因此,指定这种改变和变型被待批权利要求所覆盖。
Claims (50)
1.营养组合物,其包含有效量的α-羟基异己酸和有效量的瓜氨酸。
2.权利要求1的营养组合物,其中所述α-羟基异己酸以约2g至约10g的量存在。
3.权利要求1的营养组合物,其中所述组合物为个体提供每天约0.15g至约10g的α-羟基异己酸,优选每天约2g至10g,更优选每天约0.5g至约5g。
4.权利要求1的营养组合物,其中所述α-羟基异己酸以约1.5g的量存在。
5.权利要求1-4任一项的营养组合物,其中所述瓜氨酸以约4g至约7g的量存在。
6.权利要求1-5任一项的营养组合物,其中所述组合物为个体提供每天约1g至约15g的瓜氨酸,更优选每天约2g至约15g的瓜氨酸,甚至更优选每天约2g至约7g,甚至更优选每天约2g至约5g的瓜氨酸。
7.前述权利要求任一项的营养组合物,其还包含ω-3脂肪酸源,其中ω-3脂肪酸源选自鱼油、磷虾、含有ω-3脂肪酸的植物源、亚麻仁、核桃、藻类及其组合。
8.权利要求7的营养组合物,其中所述ω-3脂肪酸选自α-亚麻酸(“ALA”)、二十二碳六烯酸(“DHA”)、十八碳四烯酸(SDA)、二十碳五烯酸(“EPA”)及其组合。
9.权利要求7或8的营养组合物,其中以每天约0.25g至5.0g,优选每天约1.0至3.0g的量提供所述ω-3脂肪酸。
10.前述权利要求任一项的营养组合物,其还包括选自脱氧核糖核酸(“DNA”)的亚基、核糖核酸(“RNA”)的亚基、DNA和RNA的聚合形式、酵母RNA,及其组合的至少一种核苷酸。
11.权利要求10的营养组合物,其中所述至少一种核苷酸是外源核苷酸。
12.权利要求10或11的营养组合物,其中以每天约0.5g至3g的量提供所述核苷酸。
13.前述权利要求任一项的营养组合物,其还包含选自黄酮类化合物、同源的酚类化合物、多酚类化合物、萜类化合物、生物碱、含硫化合物,及其组合的植物营养素。
14.权利要求13的营养组合物,其中所述植物营养素选自类胡萝卜素、植物甾醇、槲皮素、姜黄素、柠檬苦素,及其组合。
15.前述权利要求任一项的营养组合物,其还包括蛋白质源。
16.权利要求15的营养组合物,其中所述蛋白质源为所述营养组合物提供至少10g的高质量蛋白质。
17.权利要求15的营养组合物,其中所述蛋白质源为个体提供每天至少10g的高质量蛋白质。
18.权利要求15至17任一项的营养组合物,其中所述蛋白质源选自基于乳制品的蛋白质、基于植物的蛋白质、基于动物的蛋白质、人工蛋白质,及其组合。
19.权利要求18的营养组合物,其中所述基于乳制品的蛋白质选自酪蛋白、胶束酪蛋白、酪蛋白酸盐、酪蛋白水解物、乳清、乳清水解物、乳清浓缩物、乳清分离物、乳清蛋白质胶束、乳蛋白质浓缩物、乳蛋白质分离物,及其组合。
20.权利要求18的营养组合物,其中所述基于植物的蛋白质选自大豆蛋白质、豌豆蛋白质、油菜蛋白质、小麦和分级分离的小麦蛋白质、玉米蛋白质、玉米醇溶蛋白、稻蛋白质、燕麦蛋白质、马铃薯蛋白质、花生蛋白质、青豆粉、菜豆粉、螺旋藻、来自蔬菜、豆类、荞麦、小扁豆、干豆的蛋白质、单细胞蛋白质,及其组合。
21.前述权利要求任一项的营养组合物,其还包括选自阿拉伯胶、α-葡聚糖、阿拉伯半乳聚糖、β-葡聚糖、葡聚糖、低聚果糖、岩藻糖基乳糖、低聚半乳糖、半乳甘露聚糖、低聚龙胆糖、低聚葡萄糖、瓜尔豆胶、菊粉、低聚异麦芽糖、乳新四糖、乳蔗糖、乳果糖、果聚糖、麦芽糖糊精、乳低聚糖、部分水解的瓜尔豆胶、果胶低聚糖、防腐的淀粉、老化淀粉、唾液酸低聚糖、唾液酰基乳糖、大豆低聚糖、糖醇、低聚木糖、其水解产物,及其组合的益生元。
22.前述权利要求任一项的营养组合物,其还包括这样的益生菌,其选自气球菌属、曲霉菌属、拟杆菌属、双歧杆菌属、假丝酵母属、梭菌属、德巴利酵母属、肠球菌属、梭杆菌属、乳杆菌属、乳球菌属、明串珠菌属、蜜蜂球菌属、微球菌属、毛霉菌属、酒球菌属、片球菌属、青霉属、消化链球菌属、毕赤酵母属、丙酸杆菌属、Pseudocatenulatum、根霉菌属、酵母菌属、葡萄球菌属、链球菌属、球拟酵母菌属、魏斯氏菌属,非复制性微生物,及其组合。
23.前述权利要求任一项的营养组合物,其还包含选自丙氨酸、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,及其组合的氨基酸。
24.权利要求23的营养组合物,其中所述氨基酸是选自异亮氨酸、亮氨酸、缬氨酸及其组合的支链氨基酸。
25.前述权利要求任一项的营养组合物,其还包含选自虾青素、类胡萝卜素、辅酶Q10(“CoQ10”)、黄酮类化合物、谷胱甘肽、Goji(枸杞)、橙皮苷、lactowolfberry、木酚素、叶黄素、番茄红素、多酚、硒、维生素A、维生素C、维生素E、玉米黄质,及其组合的抗氧化剂。
26.前述权利要求任一项的营养组合物,其还包含选自维生素A、维生素B1(硫胺素)、维生素B2(核黄素)、维生素B3(烟酸或烟酰胺)、维生素B5(泛酸)、维生素B6(吡哆醇、吡哆醛、吡哆胺、或盐酸吡哆醇)、维生素B7(生物素)、维生素B9(叶酸),和维生素B12(多种钴胺素;通常是维生素补充剂中氰钴胺素)、维生素C、维生素D、维生素E、维生素K、K1和K2(即,MK-4、MK-7)、叶酸、生物素及其组合的维生素。
27.前述权利要求任一项的营养组合物,其还包含选自硼、钙、铬、铜、碘、铁、镁、锰、钼、镍、磷、钾、硒、硅、锡、钒、锌,及其组合的矿物质。
28.前述权利要求任一项的营养组合物,其还包括选自α-酮戊二酸、L-肉碱,及其组合的化合物。
29.前述权利要求任一项的营养组合物,其中所述营养组合物是选自片剂、胶囊剂、液体剂、咀嚼剂、软胶囊、囊剂、粉剂、糖浆剂、液体混悬剂、乳剂、溶液剂,及其组合的形式。
30.前述权利要求任一项的营养组合物,其中所述营养组合物是口服营养补充剂或管饲液。
31.前述权利要求任一项的营养组合物,其中所述营养组合物是完全营养或不完全营养的来源。
32.营养组合物,其包含有效量的α-羟基异己酸和瓜氨酸,其用于:
i)在有其需要的个体中刺激肌肉蛋白质合成,或
ii)在有其需要的个体中使肌肉蛋白质分解代谢最小化,或
iii)在有其需要的个体中保持瘦体重,或
iv)在有其需要的个体中减少去负荷诱导的骨质流失,或
v)在有其需要的个体中缓解骨骼肌萎缩,或
vi)在有其需要的个体中减轻高尿毒症负荷。
33.权利要求32的营养组合物,其中所述个体选自老年人、具有医学状况的那些人,及其组合。
34.权利要求33的营养组合物,其中所述老年人包括由于少肌症、脆弱处于无能风险中的那些人。
35.权利要求32至34任一项的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约0.15g至约10g的α-羟基异己酸,优选每天约2g至10g,更优选每天约0.5g至约5g。
36.权利要求32至34任一项的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约150mg至约2.5g的α-羟基异己酸,优选每天约1.5g的α-羟基异己酸。
37.权利要求32至36的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约1g至约15g的瓜氨酸,更优选每天约2g至约15g的瓜氨酸,甚至更优选每天约2g至约7g,甚至更优选每天约2g至约5g的瓜氨酸。
38.权利要求32至36的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约2g至约15g的瓜氨酸,优选每天约4g至约7g的瓜氨酸。
39.前述权利要求任一项的营养组合物,其中所述营养组合物还包括选自鸟氨酸α-酮戊二酸盐、精氨酸α-酮戊二酸盐及其组合的形式的α-酮戊二酸。
40.权利要求39的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约2g至20g的α-酮戊二酸。
41.权利要求39的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约10g至约30g的α-酮戊二酸。
42.前述权利要求任一项的营养组合物,其还包括ω-3脂肪酸源,其中所述ω-3脂肪酸源选自鱼油、磷虾、含有ω-3脂肪酸的植物源、亚麻仁、核桃、藻类及其组合。
43.权利要求42的营养组合物,其中所述ω-3脂肪酸选自α-亚麻酸(“ALA”)、二十二碳六烯酸(“DHA”)、十八碳四烯酸(SDA)、二十碳五烯酸(“EPA”),及其组合。
44.权利要求7或8的营养组合物,其中以每天约0.25g至5.0g,优选每天约1.0至3.0g的量提供所述ω-3脂肪酸。
45.权利要求43的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约0.25g至约5g,更优选约250mg至约3g的二十碳五烯酸。
46.权利要求43的营养组合物,其中向所述个体施用所述营养组合物,以为该个体提供每天约250mg至约1.5g的二十碳五烯酸。
47.前述权利要求任一项的营养组合物,其中所述营养组合物还包括选自脱氧核糖核酸(“DNA”)的亚基、核糖核酸(“RNA”)的亚基、DNA和RNA的聚合形式、酵母RNA,及其组合的至少一种核苷酸。
48.权利要求47的营养组合物,其中所述至少一种核苷酸是外源核苷酸。
49.前述权利要求任一项的营养组合物,其中所述营养组合物还包括选自亮氨酸、异亮氨酸、缬氨酸及其组合的至少一种支链氨基酸。
50.前述权利要求任一项的营养组合物,其中所述营养组合物还包括L-肉碱。
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CN107809916A (zh) * | 2015-06-26 | 2018-03-16 | 维塔尔奈克斯特有限责任公司 | 用于治疗营养不良的组合物和方法 |
CN109982585A (zh) * | 2016-11-16 | 2019-07-05 | 费森尤斯卡比德国有限公司 | 用于患有肌少症和/或衰弱症的患者或肌少症前期和/或衰弱症前期患者的疗法中的用途的营养组合物 |
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CN107242572A (zh) * | 2017-07-06 | 2017-10-13 | 广州彤博士健康科技有限公司 | 营养补充剂及制备方法 |
CN107616505A (zh) * | 2017-10-24 | 2018-01-23 | 精晶药业股份有限公司 | 一种含有鸟氨酸酮戊二酸的保健品及其制备方法 |
CN114029085A (zh) * | 2021-12-06 | 2022-02-11 | 中触媒新材料股份有限公司 | 一种烯烃环氧化催化剂及其制备方法和应用 |
CN114029085B (zh) * | 2021-12-06 | 2024-02-27 | 中触媒新材料股份有限公司 | 一种烯烃环氧化催化剂及其制备方法和应用 |
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