CN104582506B - 用于促进患有炎症性肠病(ibd)的患者的肌肉骨骼健康的营养组合物 - Google Patents

用于促进患有炎症性肠病(ibd)的患者的肌肉骨骼健康的营养组合物 Download PDF

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CN104582506B
CN104582506B CN201380040258.8A CN201380040258A CN104582506B CN 104582506 B CN104582506 B CN 104582506B CN 201380040258 A CN201380040258 A CN 201380040258A CN 104582506 B CN104582506 B CN 104582506B
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acid
alimentation composition
vitamin
alimentation
patient
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CN104582506A (zh
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E·席夫林
V·布拉姆巴特
F-P·马丁
J·本雅各布
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Societe des Produits Nestle SA
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Societe dAssistance Technique pour Produits Nestle SA
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Abstract

公开了用于促进患有炎症性肠病患者的肌肉骨骼健康的营养组合物。营养组合物包含酪蛋白、维生素K1:K2的比率为3:1至1:3的维生素K且提供3.5‑20μg/100kcal营养组合物之间的维生素K、维生素D和α‑亚麻酸。还公开了包含营养组合物的药物制剂、营养制剂、管饲制剂、饮食补充剂、功能食品、饮料产品或其组合。还公开了用于改善肌肉骨骼健康的方法。

Description

用于促进患有炎症性肠病(IBD)的患者的肌肉骨骼健康的营 养组合物
发明领域
本公开涉及营养组合物、特别地是用于患有炎症性肠病的患者的营养组合物。本公开还涉及用于改善患者、特别地是患有炎症性肠病的患者的肌肉骨骼健康的方法。
发明背景
炎症性肠病是指牵涉胃肠道炎症的一组疾病。
局限性回肠炎是炎症性肠病的实例。局限性回肠炎可影响从口腔至肛门的整个胃肠道。
局限性回肠炎的确切病因尚不清楚。据信局限性回肠炎由与身体免疫系统相互作用的遗传、非遗传或环境因素(例如感染)的组合引起并且这影响胃肠道。
局限性回肠炎是其中身体免疫系统错误地袭击并破坏胃肠道的健康组织的慢性炎症性病症。局限性回肠炎的体征和症状牵涉发作和缓解的慢性复发期。
局限性回肠炎可导致胃肠道、肠外和全身并发症。胃肠道并发症可包括腹泻、腹痛、发烧和直肠出血。肠外并发症包括眼睛、骨骼、皮肤异常和血液异常的问题。此外，局限性回肠炎的肠外并发症导致造成骨质疏松症的骨密度减少或造成软骨病的骨软化增加。与局限性回肠炎有关的全身并发症包括儿童的生长延迟、由于食物摄入减少造成的重量减轻和进一步加剧重量减轻的碳水化合物或脂质的吸收不良。
没有针对局限性回肠炎的单一治疗。如果缓解局限性回肠炎是可能的，则可预防复发，并且症状通过药物治疗、改变生活方式、用营养组合物干预以及在一些情况下通过手术来控制。
对局限性回肠炎的治疗仅在症状活跃时是可能的。对局限性回肠炎的治疗通常牵涉首先治疗急性问题，然后保持缓解。
需要提供可校正患有局限性回肠炎患者的代谢变化并且预防并校正患有局限性回肠炎患者的局限性回肠炎相关改变的营养组合物。
需要能够监测患有局限性回肠炎的患者、能够在缓解期过程中预测局限性回肠炎在其发生之前的复发和缓解作用的可能性。用所谓的生物标记实现以这种方式监测患有局限性回肠炎的患者。生物标记允许可能进行早期营养干预以保持缓解状态。因此，需要鉴定可用作诊断工具的患有局限性回肠炎患者的生物标记。
已知营养组合物向患有炎症性肠病(例如局限性回肠炎)的患者提供单独营养组合物和/或补充营养组合物。营养组合物是炎症性肠病(例如局限性回肠炎)的首选疗法。营养组合物可能使炎症活动得以控制并且能使患者保持缓解状态。
由Nestlé制造的营养组合物-Modulen IBD是已知的。参见例如于2012年6月1日下载并浏览的产品信息单http://www.nestlenutrition.co.uk/healthcare/gb/products/Documents/Modu len％20IBD-nutritionpanel.pdf。Modulen IBD用于患有炎症性肠病(例如局限性回肠炎)的患者。已知Modulen IBD含有27μg/100g的量的维生素K。已知ModulenIBD含有4.9μg/100g的量的维生素D。已知Modulen IBD含有0.2g/100g的量的α-亚麻酸。Modulen IBD为基于酪蛋白的组合物。Modulen IBD中的酪蛋白提供抗炎症性细胞因子-转化生长因子-β2。已显示转化生长因子-β2在患有活跃炎症性肠病(例如局限性回肠炎)的儿童中诱导缓解。转化生长因子-β2因其控制炎症性活性而促进胃肠道的粘膜愈合。此外，转化生长因子-β2具有免疫调节性。
WO2011/031601公开了营养组合物以及制备和使用营养组合物的方法。营养组合物包括外源性维生素K2。营养组合物还可以包括选自磷、镁、锌、铁、铜、锰、钙、维生素D、骨桥蛋白及其组合的另外组分。
发明概述
需要提供促进患有炎症性肠病(例如局限性回肠炎)的患者的肌肉骨骼健康的营养组合物。
需要提供恢复患有炎症性肠病(例如局限性回肠炎)的患者的代谢特征的营养组合物。
患者可以为儿科或青少年患者。儿科患者为年龄为0至18岁、0至17岁或0至17岁的患者。0的年龄是指与出生是否为早产无关的出生时间。青少年患者为年龄为13至19、13至18、或13至17岁的患者。
第一方面，本公开涉及营养组合物。所述营养组合物包含酸性酪蛋白、维生素K1:K2的比率为3:1至1:3的维生素K且维生素K以17.5至100μg/100g营养组合物之间的量存在、以2.5至75μg/100g营养组合物的量存在的维生素D；和n6:n3脂肪酸的比率为5:1至1:5的n6/n3脂肪酸。
另一方面，本公开涉及包含营养组合物的药物制剂、营养制剂、管饲制剂、饮食补充剂、功能食品、饮料产品或其组合，所述营养组合物包含酸性酪蛋白、维生素K1:K2的比率为3:1至1:3的维生素K且维生素K以17.5至100μg/100g营养组合物之间的量存在、以2.5至75μg/100g营养组合物的量存在的维生素D；和n6:n3脂肪酸的比率为5:1至1:5的n6/n3脂肪酸。
另一方面，本公开涉及改善儿科患者的肌肉骨骼健康的方法。所述方法包括向需要其的儿科患者施用营养组合物，所述营养组合物包含酸性酪蛋白、维生素K1:K2的比率为3:1至1:3的维生素K且维生素K以17.5至100μg/100g营养组合物之间的量存在、以2.5至75μg/100g营养组合物的量存在的维生素D；和n6:n3脂肪酸的比率为5:1至1:5的n6/n3脂肪酸。
附图简述
图1示出当用根据本公开的营养组合物施用时年龄为6.6-17.7岁的患有局限性回肠炎的儿童的儿科局限性回肠炎活动指数(PCDAI)。
图2示出当向年龄为6.6-17.7岁的患有局限性回肠炎的儿童施用时本公开的营养组合物对骨密度和肌肉横截面积的影响。
详细描述
为了完全理解本公开及其优点，与附图结合参考下列详细描述。
应理解，本文公开的本发明的各个方面仅仅说明了制备并使用本公开的特定方法并且当考虑所附权利要求、详细描述和附图时不限制本公开的范围。
应理解，本领域技术人员根据本文公开的本公开的描述或实施例应明了本公开的一个方面的特征，并且那些特征可与本公开的其它方面/实施方案的特征组合。
如在本公开和所附权利要求中使用，除非上下文另外清楚指明，否则单数形式“一个/种”和“该”包括复数指示物。
本发明人已开发炎症性肠病(例如局限性回肠炎)的营养组合物。
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，和疾病或疾患特异性营养组合物。完全营养组合物(即含有所有必要常量和微量营养素的那些)可用作患者的单一营养来源。患者由此类完全营养组合物可接受100％的其营养需求。部分或不完全营养组合物不含所有必要的常量和微量营养素并且不能用作患者的单一营养来源。部分或不完全营养组合物可用作营养补充剂。疾病或疾患特异性营养组合物为递送营养素或药物的组合物并且可以为完全或部分营养组合物。
已发现，营养组合物当在炎症性肠病(例如局限性回肠炎)活跃期使用时：可诱导缓解(如通过PCDAI评分和内窥镜评估所指示)可下调炎症性响应，促进肠粘膜愈合，可促进重量增加，可促进线性生长且改善营养状况以及改善肌肉骨骼变化。
PCDAI评分为本领域熟知的且PCDAI是指儿科局限性回肠炎活动指数。PCDAI为可靠的、经验证的多参数测量，其分类儿童和青少年中的疾病活性。发现本公开的营养组合物在治疗的前两周内显著地减少PCDAI–在8周内减少至最小值，如图1中描述。
营养组合物包含酸性酪蛋白、维生素K1:K2的比率为3:1至1:3的维生素K且维生素K以17.5至100μg/100g营养组合物之间的量存在、以2.5至75μg/100g营养组合物的量存在的维生素D；和n6:n3脂肪酸的比率为 5:1至1:5的n6/n3脂肪酸。
酸性酪蛋白通过对乳酸化直至达到酪蛋白的等电点(pH 4.7)而生成。随后，所谓的酸性酪蛋白沉淀。此方法在本领域是充分确立的(参见US4397926的背景部分)。通常，在变酸乳清的影响下、酪蛋白从准确脱脂的乳持续凝聚的过程中获得酸性酪蛋白。然而，其他生成方法是可用的。
酸性酪蛋白在天然存在的转化生长因子β-2(TGF-β2)中是高含量的。转化生长因子β-2(TGF-β2)是在肠粘膜愈合中起重要作用的抗炎症性细胞因子。
维生素K指示一组具有常见化学环结构(萘醌)的亲脂性、疏水性必需维生素。维生素K1是被称为叶绿醌或植物甲萘醌的单个化合物，且维生素K2是被称为甲基萘醌类或四烯甲萘醌(menatetrenones)的一系列维生素。
正如所述，已知炎症性肠病(例如局限性回肠炎)损害骨生长、骨质量，并且最终损害骨密度。患有炎症性肠病(例如局限性回肠炎)的患者中低骨量的发生率为约30-50％范围。维生素K通常在患有炎症性肠病(例如局限性回肠炎)的患者中缺乏并且继发的有限生物利用度可在骨量形成期间减少骨钙素羧化作用以及减少骨强度、骨矿化和骨微架构。因此，具有炎症性肠疾病(例如局限性回肠炎)的患者受益于更有效剂量的维生素K。低维生素K水平可导致骨再吸收的速率增加，而骨形成速率没有代偿行增加。
维生素K2在没有负面影响抗凝参数的情况下允许更有效形式的维生素K，而不是经由更高的维生素K1摄入来增加摄入水平。与维生素K1比较，维生素K2通过比维生素K1更长的半衰期而提供增强的吸收和更稳定的血清水平。维生素K2至肝外组织的吸收增强允许对改善患有炎症性肠病(例如局限性回肠炎)患者的肌肉骨骼健康产生更大的影响。
本申请人已令人惊讶地发现，施用作为营养组合物的部分的、维生素K1:K2的比率为3:1至1:3的维生素K且维生素K以17.5至100μg/100g营养组合物之间的量存在，会在儿童的正常生长和发育期间改善骨钙素羧化并改善骨健康指数。此外，维生素K补充还促进患有炎症性肠疾病(例 如局限性回肠炎)患者的骨生长和骨质量。营养组合物当在患有炎症性肠疾病(例如局限性回肠炎)的患者中施用时增加骨密度并且改善骨组织微架构，从而减少骨折风险的发生率。维生素K的作用在骨质量方面被直接观察到，从而这种形式的维生素K调控在涉及微架构形态学、矿化、密度、弹性和机械刚度的骨的有机基质中的蛋白质形成，如通过外周定量计算机断层摄影术(“pQCT”)或双能X射线吸收测量术(“DEXA”)所测量。
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))与胶片上的骨图像(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)并且通常用于前臂或胫骨。辐射源(通常x射线)和传感器围绕所检查的骨旋转，然后在计算机屏幕上以三维图像重新构建。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测量真实的骨密度(体积矿物质骨密度)，因为它所归一化的骨矿物质含量不是由投影面积、而是由所检查的骨的体积推导的。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，其基本原理是基于由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骨矿化。DEXA的准确度为4-10％，且变异系数为1-1.5％。
在一个优选实施方案中，维生素K以维生素K1:K2的比率为2:1至1:2的维生素K的量存在。
在一个优选实施方案中，维生素K以维生素K1:K2的比率为1:1的维生素K的量存在。
在一个优选实施方案中，维生素K以20至50μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素K以20至40μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素K以22至30μg/100g营养组合物的 量存在。
在一个优选实施方案中，维生素K以25至30μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素K以26至28μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素K以27/100g营养组合物的量存在。
维生素D是用于骨无机基质发育的重要营养素。维生素D以2.5至75μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素D以7.5至70μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素D以7.5至15μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素D以10至13μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素D以11至12μg/100g营养组合物的量存在。
在一个优选实施方案中，维生素D以11.6μg/100g营养组合物的量存在。
图2示出通过肠道喂食施用营养组合物12周可显著地改善年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童的骨密度。
此外，由于n6/n3脂肪酸和/或其混合物的存在，营养组合物具有增强的用于粘膜愈合的抗炎症性活性。n6/n3脂肪酸以5:1至1:5的n6:n3脂肪酸的比率存在。因为营养组合物促进粘膜愈合，所以患有炎症性肠病(例如局限性回肠炎)的患者中营养素的吸收有所改善。
n3 ω-脂肪酸的实例为十六碳三烯酸(HTA)C16:3、α-亚麻酸(ALA)C18:3、十八碳四烯酸(SDA)C18:4、二十碳三烯酸(ETE)C20:3、二十碳四烯酸(ETA)C20:4、二十碳五烯酸(EPA)C20:5、二十一碳五烯酸(HPA)C21:5、二十二碳五烯酸(DPA)C22:5、二十二碳六烯酸(DHA)C22:6、二 十四碳五烯酸C24:5和二十四碳六烯酸C24:6。
在一个优选实施方案中，n3 ω-3-脂肪酸为二十碳五烯酸(EPA)C20:5和二十二碳六烯酸(DHA)C22:6。
n3 ω-3-脂肪酸可源自鱼油、藻油(algal oil)、鱿鱼油(squid oil)和植物油如蓝蓟油(echium oil)和亚麻籽油和/或其混合物。
n6、ω-6-脂肪酸的实例为亚麻酸(LA)C18:2、γ-亚麻酸(GLA)C18:3、二十碳二烯酸C20:2、二高-γ-亚麻酸(DGLA)C20:3、花生四烯酸(AA)C20:4、二十二碳二烯酸C22:2、肾上腺酸C22:4、二十二碳五烯酸C22:5、二十四碳四烯酸C24:4、二十四碳五烯酸C24:5和十八碳三烯酸C18:3。
n6 ω-6-脂肪酸可源自家禽、蛋、鳄梨、坚果、谷物、硬质小麦、全麦、蔬菜油、月见草油、琉璃苣油(borage oil)、黑醋粟(blackcurrant)籽油、亚麻/亚麻籽油、菜籽油、低芥酸菜子油、大麻油、大豆油、棉花籽油、葵花籽油、玉米油、红花油、南瓜籽、阿萨伊果(acaiberry)、腰果和螺旋藻属和/或其混合物。
在一个优选实施方案中，n3 ω-3-脂肪酸为α-亚麻酸(ALA)C18:3且n6 ω-6-脂肪酸为亚麻酸(LA)C18:2。
图2示出通过肠道喂食施用营养组合物12周可显著地改善年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童的肌肉横截面积。
营养组合物还可以包括一种或多种氨基酸。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、羟基丝氨酸、羟酪氨酸、羟赖氨酸、异亮氨酸、亮氨酸、赖氨酸、蛋氨酸、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。
在另一个实施方案中，营养组合物可以包含矿物质，如钠、钾、钙,磷、镁、氯化物、铁、锌、铜、锰、氟化物、铬、钼、硒、碘化物或其任何组合。
在另一个实施方案中，营养组合物还包含维生素，如维生素A、维生 素E、维生素C、维生素B1、维生素B2、泛酸、维生素B6、维生素B12、烟酸、叶酸、生物素和胆碱或其任何组合。
在另一个实施方案中，营养组合物还包括一种或多种益生元。如本文所使用，益生元为选择性发酵的成分，其允许在胃肠微菌群的组成和/或活性发生特定的改变，这些改变给宿主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、半乳低聚糖、阿拉伯树胶、大豆低聚糖(soyoligosaccharides)、低聚木糖(xylooligosaccharides)、低聚异麦芽糖(isomaltooligosaccharides)、低聚龙胆糖(gentiooligosaccharides)、低聚乳果糖(lactosucrose)、低聚葡萄糖、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。
在另一个实施方案中，营养组合物还包括一种或多种益生菌。如益生菌优选为微生物(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，据信这些益生菌抑制和/或影响致病菌在肠道中的生长和/或代谢。益生菌还可以激活宿主的免疫功能。益生菌的非限制性实例包括酵母属(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)、曲霉菌属(Aspergillus)、根霉菌属(Rhizopus)、毛霉菌属(Mucor)、青霉属(Penicillium)、双歧杆菌属(Bifidobacterium)、类杆菌属(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)、芽孢杆菌属(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。
另一个实施方案中，营养组合物还包含合生元(synbiotic)。合生元为含 有一种或多种益生元和一种或多种益生菌的补充剂。一种或多种益生元和一种或多种益生菌一起工作以改善肠道的微菌群。合生元包含上文提及的一种或多种益生元和一种或多种益生菌的任何组合。
在另一个实施方案中，营养组合物包含药学上可接受的载体和/或风味剂和/或着色剂。风味剂的使用向营养组合物提供使营养组合物对患有炎症性肠病(例如局限性回肠炎)的患者更可口的风味。
在一个优选实施方案中，营养组合物呈用液体重构的粉末形式。
营养组合物可以呈可施用形式，如药物制剂、营养制剂、管饲制剂、饮食补充剂、功能食品、饮料产品或其组合。
如本文所使用，“管饲”制剂优选为向患者胃肠道施用的完全或不完全营养产品，而不是通过口服施用，包括但不限于鼻胃管、口胃管、胃管、空肠造口术管(J-管)、经皮内镜胃造瘘术(PEG)、口(port)、如提供达到胃、空肠的胸壁口和其它适合的入口。
本公开的营养组合物在患有炎症性肠病(例如局限性回肠炎)的患者中是有利的，其希望避免用药物疗法的治疗以及避免与药物疗法相关的副作用。
本公开的营养组合物可作为药物疗法的补充剂用于患有炎症性肠病(例如局限性回肠炎)的患者中。
本公开的营养组合物在未能响应于药物治疗的患有炎症性肠病(例如局限性回肠炎)的患者中是有利的。
实施例
根据表1制造根据本公开的营养组合物。
“营养组合物的实例-成分/100g”这一列示出了当营养组合物呈粉末形式时，基于营养组合物成分/100g营养组合物的营养组合物的实例。
“每份公布值：20.4g营养组合物(粉末)/84ml水以形成100ml重构配方”这一列示出了当20.4g营养组合物实例用84ml水重构以形成100ml呈液体形式的营养组合物时，基于营养组合物成分的营养组合物。
表1：
(上表中的“,”为小数点，且由此在全世界“.”用于指示小数点的那些地区中如在USA中被解释为“.”)
在12周的时间内向年龄为6.6-17.7的患有炎症性肠病(例如局限性回肠炎)的儿童施用重构的营养制剂。
记录基线特征后，向年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童施用作为单独营养支持物的营养组合物4周，以实现临床缓解。然后继续施用8周。
在第一次访问后4周和12周随访年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童。在第一次访问和在12周时测量肌肉横截面积和骨密度。
在第一次访问时和在用代谢组学(metabonomics)方法营养干预4周后获得年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童的血浆代谢特征。代谢组学方法包括根据制造商说明使用Biocrates Life Sciences AbsoluteIDQTM试剂盒。用多变量统计处理年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童的血浆代谢特征，以鉴定代谢信息(生物标记)。代谢信息(生物标记)指示年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童响应于营养组合物干预的生理状态。观察到血浆代谢特征随着时间推移的代谢轨迹，这与循环氨基酸和脂质的不同差异相关。
观察到显著性差异。
观察到，用营养组合物干预4周，能够部分恢复年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童的代谢特征。与年龄匹配的对照相比，在第一次访问时年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童的氨基酸和脂质的最初概括分析表明许多代谢物的显著性减少。
用营养组合物干预4周不仅能够诱导炎症性肠病急性发作影响的缓解，而且令人惊讶地恢复氨基酸苏氨酸、组氨酸和色氨酸的水平。而且，还观察到恢复氨基酸脯氨酸和谷氨酰胺的明确趋势。因此，营养组合物还可以包含氨基酸，以反映处于炎症性肠病急性发作影响的缓解状态的患者中发现的氨基酸水平的恢复。
除蛋白质分解代谢响应之外，当与年龄匹配的对照比较时，也观察到第一次访问时各个脂质种类的减少。与氨基酸响应类似，营养干预在4周后能够恢复多种脂质代谢物的合成代谢响应。结果指示营养组合物可使分解代谢响应转换为合成代谢响应。
还已发现，本公开的营养组合物在治疗的前四周内显著地减少PCDAI(儿科局限性回肠炎活动指数)–在8周内减少至最小值，如图1中描述。
此外，由于肌肉分解被认为有助于血浆氨基酸的浓度，所以如上所述恢复这些氨基酸的营养干预将减少肌肉分解代谢应激。为了表明这种效应，建立了第一次访问和在12周后肌肉横截面积的Z评分。Z评分测量了肌肉横截面积相比于参照群体的变化。如图2中所示，用营养组合物干预4周能够减轻肌肉横截面积损失并在12周内增进肌肉横截面积。
因此，表明年龄为6.6-17.7岁的患有炎症性肠病(例如局限性回肠炎)的儿童中的营养干预能够校正代谢中断，从而减轻肌肉的分解代谢响应以及减轻炎症性肠病(例如局限性回肠炎)相关的肌肉骨骼改变。
此外，注意到，维持疗法中施用营养组合物，导致显著更长地延迟复发。因此，营养组合物促进更长的缓解期，在缓解期过程中在患有炎症性肠病(例如局限性回肠炎)的患者的肌肉横截面积和骨密度得以改善。
已令人惊讶地发现，以在上述范围内的比率使用的组分的量起重要的作用，并且当在患有炎症性肠病的患者中使用组合物时是有利的。在患有炎症性肠病的患者中，营养组合物促进并改善肌肉横截面积和骨密度，营养组合物还导致显著更长地延迟复发。
鉴于已详细地描述本公开及其优点，应理解，上述的本公开的详细描述不旨在限制本文公开的范围。
本领域技术人员通过组合各个方面和实施方案能够实施本公开。本公开不限于详细描述和/或实施例。

Claims (25)

1.营养组合物，包含：
酸性酪蛋白，
维生素K1:K2的比率为3:1至1:3的维生素K，且维生素K以17.5至100μg/100g所述营养组合物的量存在，
以2.5至75μg/100g所述营养组合物的量存在的维生素D；和
n6:n3脂肪酸的比率为5:1至1:5的n6/n3脂肪酸及其混合物。
2.权利要求1的营养组合物，其中所述n6,ω-6-脂肪酸选自下组：亚麻酸C18:2、γ-亚麻酸C18:3、二十碳二烯酸C20:2、二高-γ-亚麻酸C20:3、花生四烯酸C20:4、二十二碳二烯酸C22:2、肾上腺酸C22:4、二十二碳五烯酸C22:5、二十四碳四烯酸C24:4、二十四碳五烯酸C24:5和十八碳三烯酸C18:3或其混合物。
3.权利要求1的营养组合物，其中n3,ω-3-脂肪酸选自下组：十六碳三烯酸C16:3、α-亚麻酸C18:3、十八碳四烯酸C18:4、二十碳三烯酸C20:3、二十碳四烯酸C20:4、二十碳五烯酸C20:5、二十一碳五烯酸C21:5、二十二碳五烯酸C22:5、二十二碳六烯酸C22:6、二十四碳五烯酸C24:5和二十四碳六烯酸C24:6或其混合物。
4.权利要求2的营养组合物，其中n3,ω-3-脂肪酸选自下组：十六碳三烯酸C16:3、α-亚麻酸C18:3、十八碳四烯酸C18:4、二十碳三烯酸C20:3、二十碳四烯酸C20:4、二十碳五烯酸C20:5、二十一碳五烯酸C21:5、二十二碳五烯酸C22:5、二十二碳六烯酸C22:6、二十四碳五烯酸C24:5和二十四碳六烯酸C24:6或其混合物。
5.权利要求1至4中任一项的营养组合物，还包含一种或多种氨基酸，所述氨基酸选自包含以下的组：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、羟基丝氨酸、羟酪氨酸、羟赖氨酸、异亮氨酸、亮氨酸、赖氨酸、蛋氨酸、苯丙氨酸、脯氨酸、丝氨酸、牛磺酸、苏氨酸、色氨酸、酪氨酸、缬氨酸或其组合。
6.权利要求1至4中任一项的营养组合物，还包含α-羟基异己酸、α-羟基异戊酸、α-羟基-β-甲基戊酸或其组合。
7.权利要求1至4中任一项的营养组合物，还包含一种或多种选自下组的矿物质：钠、钾、钙、磷、镁、氯化物、铁、锌、铜、锰、氟化物、铬、钼、硒、碘化物或其任何组合。
8.权利要求1至4中任一项的营养组合物，还包含一种或多种另外的维生素，所述维生素选自维生素A、维生素E、维生素C、维生素B1、维生素B2、泛酸、维生素B6、维生素B12、烟酸、叶酸、生物素和胆碱或其任何组合。
9.权利要求1至4中任一项的营养组合物，还包含一种或多种益生元，所述益生元选自包含以下的组：低聚果糖、菊粉、乳果糖、半乳低聚糖、阿拉伯树胶、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。
10.权利要求1至4中任一项的营养组合物，还包含一种或多种益生菌，所述益生菌选自包含以下的组：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)、曲霉菌属(Aspergillus)、根霉菌属(Rhizopus)、毛霉菌属(Mucor)、青霉属(Penicillium)、双歧杆菌属(Bifidobacterium)、类杆菌属(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)、芽孢杆菌属(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。
11.权利要求1至4中任一项的营养组合物，还包含药学上可接受的载体、风味剂和着色剂或其任何组合。
12.包含权利要求1至11中任一项的营养组合物的药物制剂。
13.包含权利要求1至11中任一项的营养组合物的管饲制剂。
14.包含权利要求1至11中任一项的营养组合物的功能食品。
15.权利要求14的功能食品，其为营养制剂或饮食补充剂。
16.包含权利要求1至11中任一项的营养组合物的饮料产品。
17.根据权利要求11的营养组合物，用于改善肌肉骨骼健康。
18.权利要求1至11任一项的营养组合物在制备用于改善患者的肌肉骨骼健康的药物中的用途，其中所述患者可任选地为儿科或青少年患者。
19.权利要求18的用途，其中所述患者患有发育延迟、发育不良、炎症性肠病、局限性回肠炎、局限性回肠炎相关的骨质减少、营养失调或其任何组合中的至少一种。
20.权利要求18至19中任一项的用途，其中所述改善的肌肉骨骼健康为改善的骨密度。
21.权利要求18至19中任一项的用途，其中所述改善的肌肉骨骼健康为改善的肌肉横截面积。
22.权利要求18至19中任一项的用途，其中所述营养组合物呈可施用形式，选自药物制剂、功能食品或其组合。
23.权利要求18至19中任一项的用途，其中所述营养组合物呈可施用形式，为管饲制剂。
24.权利要求18至19中任一项的用途，其中所述营养组合物呈可施用形式，为饮料产品。
25.权利要求22的用途，其中所述功能食品选自营养制剂或饮食补充剂。
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