CN101370395A - 用于改善膜组成的包含多不饱和脂肪酸的组合物 - Google Patents
用于改善膜组成的包含多不饱和脂肪酸的组合物 Download PDFInfo
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Abstract
现在已经发现,在对患者或处于形成这样的疾病危险中的人给予保健或药物组合物之后,这些人的健康得到改善,其中该保健或药物组合物包括:包含二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)中的至少一种的脂质成分;包含提供至少半胱氨酸和/或牛磺酸的来自非人类来源的蛋白类物质的蛋白质成分;以及包含锰和钼中的至少一种的矿物成分。多种类型的哺乳动物细胞的膜功能得到改善,这允许有效治疗免疫相关的失调,例如变态反应、自身免疫性疾病、癌症、认知功能障碍和神经系统的其他疾病,神经病变,例如糖尿病神经病变和神经病理性疼痛、胰岛素抵抗期间的神经元损伤,以及消化道疾病,并支持在成长或恢复期间消化道和肺功能的形成。
Description
技术领域
本发明涉及保健品和药物组合物,更具体地涉及可改善细胞的膜组成和功能(机能)的组合物以及通过其改善整个细胞功能的组合物。
背景技术
已知活细胞中的(细胞)膜具有许多重要的功能。质膜充当对细胞外成分(例如化合物、抗原和细胞)的屏障;膜(细胞内的膜及质膜)调节多种成分从细胞或细胞器的外部向内部转移,反之亦然。膜形成用于许多内源性反应,例如许多对于生物合成很重要的酶控反应、化合物的同化作用(合成代谢)或异化作用(分解代谢)的基质。膜对认知和调节来自外界的信号也很重要并因此有助于有机体的正确响应。与外界的相互作用包括宿主细胞与外来细胞或其部分(如抗原/变应元)的相互作用、宿主细胞与信号分子(如胰岛素、趋化因子、细胞因子和激素)的相互作用,以及宿主细胞相互之间的相互作用,例如神经细胞之间、尤其是在中枢神经系统(脑和脊髓中)内的那些神经细胞之间的相互作用。
在本领域中,许多文章揭露了活细胞与细胞外信号相互作用的方式的具体方面。膜中的靶蛋白的磷酸化,由于可在受体与细胞外配体分子结合之后发生,看起来对于信号转导的类型和量值(magnitude)很重要。同样重要的是信号转导分子复合体与特定的细胞内蛋白或膜结合蛋白的组合(assembly)。这些蛋白例如调节蛋白或支架蛋白可以包含一个或多个特定的结构域,例如SH2、SH3、PTB、以及PTZ和WW结构域类型(参见G.Cesarini et al.(eds):Modular Protein Domains.Wiley VCH Verlag,2004)。细胞对外部信号的反应还依赖于膜的特性。尤其是一些磷脂酰肌醇(PI)相关化合物的存在,看起来对于通过具有普列克底物蛋白(pleckstrin)同源(PH)结构域的蛋白(例如蛋白激酶C(PKC))实现的功能很重要。
活细胞对细胞外信号的反应的方式可广泛变化并且包括磷脂代谢的特异性激活、特异性细胞粘附行为、GTP酶活性的变化、蛋白激酶活性(例如PKC的活性)的定域化(局部化,localization)、特定转录因子的表达、胰岛素受体的敏感性调节、以及受体和离子通道的空间排布或活性。
神经细胞(神经元)之间的相互作用要求激活离子通道,包括Na+、K+和Ca2+通道。另外,受体数量的调节,也与受体的不同类型有关,其对于正确的认知、情绪和感觉运动(例如,听觉、嗅觉、触觉和味觉)功能很重要。这样的调节也通过神经调节蛋白(Nrg-1)和突触后密度蛋白(PSD-95)(它们的功能看起来依赖于膜组成)加以介导。最后,信号转导将导致多种特异性基因的激活,它们一起调节意识、行为以及认知和智力能力。
细胞膜包括多种化学成分,如磷脂、胆固醇、糖脂、鞘脂、硫苷脂(sulfatide)、脑苷脂(cerebroside)、神经节苷脂(ganglioside)、蛋白质(包括糖蛋白)、肽、离子、维生素、以及除水之外的许多其他成分。通常这些成分并非均匀地分布在膜上。极性和非极性区域可被鉴别。尤其是对于所谓的“筏(raft)”,质膜中常见的小非极性区域,已经被分配了特定的功能(Brown,D.A.,London,E.,(2000)J.Biol.Chem.275:17221—17224)。
由于物理和/或酶促过程,膜的组成随时间经历许多变化。膜状结构还形成高尔基体(Golgi apparatus)和内质网(ER)的大部分而它们的结构决定它们可能的功能和性质。
已经描述了多种用来影响神经细胞之间的相互作用以及改善认知功能的方法。
US 2005/0009779披露了一种用来增大膜流动性和以这种方式改善受体功能的方法。它主张(声称)饱和脂肪酸和胆固醇使膜变硬以及长链多不饱和脂肪酸与改善蛋氨酸代谢的某些成分一起可使细胞膜以更佳方式发挥功能。该文献没有记载,例如,关于存在不同于磷脂的极性膜成分的重要性,和关于食物成分,如锰、钼、牛磺酸、半胱氨酸、硫酸盐(酯)、水的作用,以及在适当的营养品中碳水化合物成分用于改善膜功能的特性。
US 2005/0203053披露了神经系统功能可通过增强脑中磷脂的生物合成而得到改善。这通过消耗尿苷来源、胆碱来源以及可选地通过消耗脂肪酸而实现。它主张突触传递被改善;神经突的数量增加以及P2Y受体的敏感性增大。对于这些食物成分的类似作用在US 2005/0176676中已经披露。
WO 2004/028529披露了一种用于改善认知功能的特定磷脂,其包括花生四烯酸,可选地结合中链甘油三酯或二十二碳六烯酸的一种来源。
WO 2005/051091披露了一种甘油磷脂结合鞘磷脂和/或胆固醇的特定混合物,该混合物类似人类母乳并且作为脂肪球存在用于婴儿制品的生产中。主张该混合物对于胎儿、婴儿和儿童的认知和视觉功能的形成有益。
已经提出将特定的脂质混合物用于治疗疾病或调节(改变)有机体的机能。
在EP 1279400中,披露了一种等渗(等张)脂质乳液,其包括60-95wt%的MCT和5-40wt%的鱼油,并且其不包括植物油。主张这种脂质混合物快速调整器官和组织的细胞膜,并在多种疾病的治疗中是有益的。
EP 0311091披露了一种用于非肠道应用的特定脂质混合物,其包括MCT、ω-3和ω-6脂肪酸、磷脂部分和维生素E。主张这样的脂质混合物对于经受手术、多重创伤、烧伤、感染、肺功能障碍和慢性炎症性疾病的患者是有益的。所披露的产品不包括完整的蛋白质或肽并且不适用于完全营养品。
EP 0484266披露了营养品,其包括DHA和EPA、每升产品约24至约82mg磷脂以及核苷酸混合物,主张其对滋养婴儿以及对于肝硬化和腹泻的饮食管理很有用。
EP 1426053披露了磷脂、鞘磷脂或半乳糖脂在制备用于抑制肿瘤细胞粘附、抑制转移细胞的粘附和/或抑制肿瘤转移生长的非肠道应用的药物组合物中的应用。提出的制剂不适用于经肠内途径的完全营养(complete nutrition)。对于其他食物成分可能干扰所主张的效力的方式,没有给出启示。
很多文章推测二十碳五烯酸(EPA)或二十二碳六烯酸(DHA)对于治疗炎性疾病的有效性。然而,在证实给予这些ω-3脂肪酸的疗效中产生了严重的困难。直到提交日期,主要在关节炎的治疗中,才可观察到统计学上的显著性改善。
本发明的一个目的是以方便的方式,尤其是通过给予美味的肠道制剂,来改变多种类型的细胞中细胞膜(尤其是筏)的组成。
发明内容
在一个方面,本发明涉及一种脂质成分,其包括二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)中的至少一种,结合尿嘧啶来源,用于改善(特别是婴儿或儿童的)神经系统或肺组织的生长和发育或治疗(特别是婴儿或儿童的)受损神经细胞。
特别地,该脂质和尿嘧啶来源可以形成适用于滋养婴儿或儿童的(部分)产品。
特别地,该尿嘧啶来源可以选自尿嘧啶(游离碱基);核苷尿苷;核苷酸,如UMP、UDP、和UTP,包括它们的盐;包括它们的组合。优选地,该来源包括尿苷和/或UMP。核苷酸盐可以尤其为一种钠盐。
在一个方面,本发明涉及一种脂质成分,包括二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)以及糖脂(包括硫苷脂)中的至少一种,用作用于改善免疫功能、宿主细胞和抗原、变应原、趋化因子、细胞因子、其他宿主细胞和/或胰岛素之间的相互作用或用于调节Th1和Th2细胞的数量比例的营养、保健或药物组合物。
本发明现在还提供一种营养保健或药物组合物,包括:
a)包含二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)中的至少一种的脂质成分;
b)包含至少提供半胱氨酸和/或牛磺酸的来自非人类来源的蛋白类物质的蛋白成分;以及可选地
c)包括锰和钼中的至少一种的矿物成分。
所述组合物优选包括约50至约120kcal/100g。
在一种实施方式中,所述组合物进一步包括核苷酸成分,其选自由核酸碱基(nucleobase),如胞嘧啶、腺嘌呤、鸟嘌呤、胸腺嘧啶;核苷(例如腺苷、胞苷和尿苷);以及它们的磷酸化形式(核苷酸),尤其是单磷酸化形式,例如尿苷一磷酸(UMP)、尿苷二磷酸(UDP)、尿苷三磷酸(UTP)组成的组中。
通常,尿嘧啶来源(包括游离核酸碱基、核苷(尿苷)和核苷酸(如UMP、UDP和UTP))与核酸碱基的其他来源(包括游离核酸碱基、核苷和核苷酸)的总和的比率相对较高,即,通常尿嘧啶的一个或多个来源提供大于25mol%,特别是大于0.36mol%,优选地大于42mol%,尤其是至少50mol%的总核酸碱基来源(包括核苷和核苷酸)。
在一种实施方式中,摩尔比[CMP+UMP]/[AMP+GMP+TMP+IMP]大于1.45,优选大于1.6,更优选至少1.8,尤其至少2.0。尤其是,该比率可以达到200,更尤其达到100。
摩尔比UMP/[AMP+GMP+TMP+IMP]优选为大于0.36,尤其是大于0.42,更尤其是至少0.5,甚至更尤其至少0.6。该比率通常达到200,尤其是达到100。
鉴于目前存在的用于婴儿制品的食品法规(food regulation),在婴儿制剂中,UMP浓度可尤其在0.1-0.42mg/100kJ的范围内和/或核苷酸的总量可尤其在0.1-1.2mg/100kJ的范围内。
包括的UMP的浓度为0.42-10mg/100kJ,尤其是0.5-10mg/kJ,对于改善的有效性,是高度有利的。核苷酸的总量可以尤其为100mg/100kJ。
组合物可以进一步包括可消化的碳水化合物成分,优选地包括半乳糖和/或核糖的来源。
优选地,脂质成分来自乳来源、来自蛋类或来自植物种子或大豆的胚乳,并且它优选地包括尺寸为0.001-10μm的脂肪球。组合物的具体实施方式在详细描述和实施例中示出。
还提供了根据本发明的一种组合物用于改善哺乳动物细胞(选自神经细胞、免疫细胞、干细胞、骨髓细胞和红血球的组的功能、用于改善哺乳动物的记忆功能、用于刺激哺乳动物的免疫功能、用于预防哺乳动物肥胖、自身免疫性疾病等中的应用。
此外,本发明的部分是所述组合物在制备用于治疗痴呆,例如阿尔茨海默氏病、神经病变、免疫功能低下、变态反应、贫血、肥胖、糖尿病、自身免疫性疾病、心律失常、心力衰竭、肿瘤、COPD、支气管炎、关节炎、肝炎、慢性炎症、脂质代谢紊乱和类风湿疾病。
附图说明
图1示出了当对大鼠(其注射了Aβ)供应根据本发明的产品时,乙酰胆碱的生物合成和转移的显著改善。
具体实施方式
现在已经发现,特定的食品组合物(也称为保健组合物)或药物组合物能够改善活细胞的功能(机能)。
根据本发明的产品包括脂质成分,其包含二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)中的一种或多种。尤其是,该产品还可包括尿嘧啶来源。
该产品可以包括一种或多种糖脂,尤其用于改善免疫功能、调节宿主细胞和抗原、变应原、趋化因子、细胞因子、其他宿主细胞和/或胰岛素之间的相互作用或者调节Th1和Th2细胞的数量的比率。
优选地,根据本发明的产品进一步包括蛋白质成分,后者提供半胱氨酸和/或牛磺酸等同物,以及可选地包括矿物成分,其包括锰和/或钼。可选地,还有利地包括可消化的碳水化合物成分和/或核苷酸来源。
脂质成分优选地提供多于30%的由配方中可消化成分提供的能量,其中使用计算因子(换算因子)为9kcal/g脂质、4kcal/g蛋白质或4kcal/g可消化碳水化合物以及对于产品中的其他成分为0kcal。优选地,该产品包括的脂质含量为32-80%的,更优选为33-60%的并且仍然更优选为36-50%的总能量含量。
脂质成分的量可通过采用适用的本领域中已知的用于测量食物基质中的脂肪含量的方法加以确定。例如,对于常规食物,脂肪含量通过采用法定方法(official method)983.23来确定,而Roese-Gottlieb方法(932.06)对于基于奶粉(dried milk)的产品则更加适用(Lehner,R.,Estoppey,A.,(1954)Mitt.Lebensmitteluntersuchung Hyg.54:183-185),同样其他方法用来测量婴儿制品或临床营养品中的脂质含量。
单个成分的量可通过采用专门设计的用来测量该特定成分的方法或通过如在983.23方法中给出的分馏从氯仿-甲醇部分的提取物中分离的脂肪成分加以确定。当两种可接受的方法在统计学上显著不同(使用P=0.05)时,采用给出最高值的方法。脂质成分可以包括甘油三酯、甘油二酯、甘油一酯、磷脂、溶血卵磷脂、糖脂、甾醇和其他脂溶性成分。对于这种应用的目的,脂质成分(而不是碳水化合物成分)被限定为包括硫苷脂、脑苷脂、神经酰胺、鞘脂、鞘磷脂、神经节苷脂和糖脂,如红细胞糖苷脂、血糖苷脂(hematoside)和乳糖酶基(神经)鞘氨醇(lactosylceramide)。用来检测食物基质中这些成分的量的具体分析方法在本领域是已知的。因此,应将这些量添加至由用于确定总脂肪的其他方法而测得的量中,只要它们没有被包含在这些检测结果中。
组合物的极性成分看起来具有乳化性能,其可能干扰在制备均质液体制品中惯用的乳化系统,其进一步包括根据本发明的量的蛋白质、可消化碳水化合物以及可选的矿物成分。通过使用乳质部分作为这些糖脂和糖蛋白的来源,适用于完全肠道营养的产品的液体形式保持均匀。
总脂质成分包括ω3系列(ω-3)的长链多不饱和脂肪酸(链长度为至少18,缩写为LCP),尤其是DHA、EPA和DPA中的一种或多种。这些脂肪酸可作为甘油三酯、磷脂、鞘脂、糖脂或其他食品级别形式存在。ω-3LCP的量必须是大于成人400mg/份,提供每天400-3300mg的这些脂肪酸的剂量。脂质成分中的DHA、EPA和DPA的总和的浓度为脂质成分的2-50%,优选5-45%,更优选20-40%。液体产品中EPA、DHA和DPA的总和的浓度为最小0.2mg/ml至最大为15mg/ml,并且优选0.3-12mg/ml,更优选0.4-11mg/ml。对于婴儿,ω3 LCP的量通常应大于30mg/份,从而提供每天30-1000mg的这些脂肪酸的剂量。
在一个具体的实施方式中,本发明的一种组合物每100g包括:
a)1000至2000mg的DHA+DPA+EPA;
b)30-80mg的半胱氨酸+牛磺酸;
c)0.3-2mg的锰+钼。
相比于脂质成分的其他成分的量,脂质成分包括相对较低量的ω6系列的长链多不饱和脂肪酸。比率ω-3/ω-6将在0.3-5,优选在0.4-4,更优选在0.5-2的范围内。ω-6 LCP的量将小于该配方中脂肪酸的50wt%,优选为5-40wt%,更优选为8-30wt%,最优选为8-20wt%并且尤其为8-15wt%。
优选地,还包括饱和脂肪酸。这些包括具有链长度为8至24个碳原子的那些脂肪酸。优选地,这些脂肪酸包括具有10、12、14和16个碳原子的那些(脂肪酸)。饱和脂肪酸如果存在,则饱和脂肪酸的量通常应为脂质相重量的6-60%,优选10-40%,更优选12-36%。尤其是,C14:0+C16:0的量通常应为脂质相重量的6-60%,优选10-40%,更优选12-36%。中链甘油三酯可以是来自所谓的MCT油来源,或者来自可可油或其他合适的来源。MCT的量通常应为脂质成分的1-60wt%,优选3-40wt%。肉豆蔻酸和棕榈酸可以作为酸、它们的盐、以及与烷基或酰基形成的酯(如甘油酯中),或者作为其他的合适形式而被包括。优选地,它们作为甘油三酯而被包括,如在棕榈仁油中或在具有一个额外的ω-3 LCP的结构化的甘油三酯中出现的,或者作为甘油二酯或甘油一酯被包括。包括饱和脂肪酸的甘油一酯和甘油二酯是优选的,因为当包括更高量的脂质时,相比于甘油三酯形式,它们看起来提供技术上的优势。
油酸(C18:1)优选存在于脂质相中。它应当以脂肪酸的5-40wt%、优选6-35wt%、更优选8-34wt%的含量存在。液体制品中的量将为每100ml液体产品在0.1-2g,优选0.15-1.2g,更优选0.2-1.0g的范围内。
可选地,脂质成分的一个重要部分将包括复合脂类(复脂),如糖脂、如鞘脂如鞘氨醇(例如鞘磷脂),酸性神经鞘糖脂如硫苷脂和神经节苷脂,以及红细胞糖苷酯。在总脂质成分中,除甘油三酯和磷脂之外的物质的量优选大于0.01wt%,优选0.015-1wt%,更优选0.02-0.5wt%。为了最好的结果,鞘磷脂的量应当大于130微摩尔,优选135-3000微摩尔,更优选140-2000mmol,并且酸性神经鞘糖脂的量应当大于0.003wt%,优选0.005-0.5wt%,更优选0.008-0.4wt%。神经节苷脂的量应当大于7mg/l液体产品,优选8-80mg/l液体产品,更优选9-40mg/l液体产品,尤其9-25mg/l液体产品。优选的神经节苷脂是GD3和GM3。
这些化合物可以在能够从微生物,如酵母、细菌,和在真菌、藻类植物和动物材料,如蛋、神经组织、成纤维细胞和乳类中分离的部分中找到。优选使用食物级成分。尤其优选使用来自乳类的部分,如包括高水平的脂肪球的提取物。这些可从酪乳的制备中并且尤其是在从酪乳制备干酪之后保留的乳清中获得。可商购获得的合适产品包括“酪乳粉”和“乳脂乳清”。
乳清包括相对较高量的小脂肪球,特别是在去除了巨大蛋白(macroprotein),如β-乳球蛋白的情况下。小脂肪球的浓度可以通过对成渣产物施用过滤技术而增大,该技术浓缩了在膜一侧上的脂质层,并去除了如盐和乳糖的分子。这种产品称为“乳清微滤渗余物”。富集酸性神经鞘糖脂的部分也可通过施用本领域已知的层析方法,如离子交换,来进行分离。
来自许多哺乳动物的乳类适用于活性成分的分离,然而,来自母马、绵羊、山羊和骆驼的乳类是特别适合的。最优选使用从绵羊乳类分离的脂质提取物。
来自绵羊乳类的脂质的量应当大于脂质成分的5wt%,优选8-60wt%,更优选10-40wt%。
例如,来自蛋、大豆、初乳、骨髓、脑、乳类尤其是富含脂肪球的酪乳,并且尤其是这些脂肪球的膜的部分是人们最感兴趣的,包含在根据本发明的产品中。这些被浓缩在复合糖脂中,其还包括相对较高浓度的除葡萄糖和果糖之外的碳水化合物。这样的部分可通过本领域已知的方法,例如通过己烷提取或离心,而使原成分脱脂加以分离。另外的方法应当应用于残余脂质或含水部分,以分离作为脂肪球膜而存在的更大极性的脂质成分。合适的方法包括选择性地除去分子量低于300的化合物,例如矿物和乳糖,或者例如通过利用过滤、吸附、层析、渗透技术或沉淀,除去所选的蛋白质,。
尤其是较小尺寸的脂肪球,尤其是直径小于4.0μm,优选小于3.0μm,更优选为0.001-2.0μm,最优选0.01-1.8μm的那些脂肪球包括感兴趣的成分。在那些情形下,其中对于患者乳脂是不希望的(例如,由于脂肪酸分布不当),优选去除至少部分的较大尺寸脂肪球,尤其是直径大于4.0微米的那些脂肪球。
因此,来自乳类的脂质成分应优选包括多于1%,更优选1.2-20wt%并且最优选1.3-16wt%的磷脂。另外,脂质成分应优选包括0.1-20%,更优选0.2-10wt%并且最优选0.6-8wt%的糖蛋白和糖脂,并且优选0.2-10wt%,更优选0.3-9wt%,最优选0.35-8wt%的胆固醇或胆甾醇酯。优选地,从乳类分离出来的脂质成分包括增加量的磷脂、糖蛋白、糖脂和胆固醇之中的至少两种,并且更优选地,所有成分的含量均高于乳脂中的含量。
最终产品中的脂质组成优选包括1-80wt%,更优选2-50wt%,最优选3-40wt%的乳类部分,富集在除甘油三酯之外的组分中,并且相比于天然物质的脂质成分中的量,其尤其包括50%更多的来源于乳类的较小脂肪球膜的糖脂和/或糖蛋白。
用于从乳制品分离富集在脂肪球中的多个部分的适当方法可以在US 6,824,809中找到,将其引入以供参考。而且,US 6,391,362披露了一种用来从乳类或乳脂的脂质成分中分离脂肪球部分的适当方式。然而,优选从其中分离较小尺寸的脂肪球,例如通过对第二水相施用微过滤。优选不磷酸化脂肪球的原始成分。
用于从乳类中分离合适的较小脂肪球的另外优选的方法是微过滤在生产黄油、松软干酪或酸奶酪之后产生的水相。特别是绵羊、山羊和骆驼的乳类是用于分离根据本发明的脂肪球部分的合适来源,即使它们的脂肪球的成分很大程度上不同于人乳类脂肪球中的成分。根据所述方法分离的脂肪球部分看起来没有潜在性干扰物质,如朊病毒、病原体或病毒。
尽管来源于这些成分的脂肪球或它们的部分是高度有效的,但是它们将不必在根据本发明的最终产品的制备过程或保质期(shelflife)内保持完整。加工过程中施加均质化步骤、以及包含入使最终产品有效的成分,例如蛋白质成分或其他脂质成分,可与存在于这些成分中的原始脂肪球相互作用。因此,通常产品中脂肪球的尺寸将增大并且50%以上的脂质成分将作为大于2微米的脂肪球并以脂质体形式提供。体积在90%以上的脂质成分将存在于直径大于0.025μm的脂肪球中。
最终产品的脂质成分每100ml液体产品包括优选多于0.56g长链多不饱和脂肪酸,更优选0.57-3.1g,最优选0.57-2.8g并且尤其是0.57-1.4g。
在那些情形下,其中半固体或固体产品中的浓度没有明确提到或者不可直接从所述每日剂量/每日成分而获得,它们可最终通过校正为干质量百分比,由所述液体产品中活性成分的浓度而进行计算,假定干质量含量为每100ml液体产品15g、每100g半固体产品35g和每100g固体产品90g。
在营养不良的个体中,每日剂量包括0.1-10g,优选0.2-5g胆固醇来源是有利的。胆固醇的合适来源包括胆固醇、其盐和酯。这样的营养不良患者可以是医院患者、经受蛋白质-能量营养不良的患者和老年人。这个组中不包括较长时期应用不良的饮食实践的那些营养不良的人,尤其意指食用相对较大量的反式脂肪酸和多不饱和脂肪酸,尤其是植物油(其已被氧化)长达数月。
矿物成分至少包括锰或钼,可选地添加镁和锌。优选锰和钼二者均包括在内并且更优选有效量的镁也包括在内。
饮食中包括锰,对于改善细胞的膜功能,尤其是神经细胞的膜功能,显得很重要。特别是那些营养不良的人或者具有遗传病或代谢失调的人已经赋予了用于产生神经鞘磷脂和/或相关化合物,如硫苷脂和糖基化神经酰胺的代谢能力。另外,在这些失调过程中或在快速成长过程中,个体对这些化合物的生物合成具有增加的需求。这样的个体的实例是经受神经性疾病,如阿尔茨海默病、帕金森病、抑郁、ME的患者,经受系统性红斑狼疮(SLE)、由神经损伤或脊髓损伤引起的瘫痪的个体,以及处于神经组织成长阶段的年幼的婴儿和胎儿、以及孕妇。
每天给予/食用的锰量对于体重80kg的人应超过7mg,优选9-300mg。液体产品中的浓度例如可通过采用日用体积并计算日用剂量和日用体积的比例进行计算。假定例如每管饲2000ml的体积获得的锰浓度为至少7/2000ml=350微克/100ml。我们还假定管饲的能量密度为1.0kcal/ml或4.2kJ/ml。因此,每100kcal的浓度为最小0.35mg/100kcal,优选0.45-15mg/100kcal或>0.83mg/100kJ,优选0.107-3.6mg/100kJ。
对于体重3kg和食用400ml的婴儿,该最小浓度为0.065mg/100ml。因此,对于能量密度为0.67kcal/ml的婴儿制品,该浓度大于约0.1mg/100kcal。
已发现,如上所述的锰的包含,对于肠道内乳酸杆菌的生长具有促进作用,并且与这种作用相关的多种益处伴随这种有益作用产生,包括体腔pH降低、肠道内病原体的较少生长以及免疫功能的强度和/或能力的增大(根据降低的感染率和/或减少的腹泻而检测)。并观察到较好的粪便稠度,尤其是发生便秘的频率。尽管这些肠道细菌增加了对锰的利用,但是观察到了对细胞功能的系统性效应,尤其是在给予给定的浓度时。
需要另外的钼,以使辅因子恰当发挥功能,这似乎对于形成膜的恰当组成(例如,它们的硫苷脂含量)很重要,尤其保证了神经细胞恰当发挥功能。而且,包含恰当量的钼,可延缓部分老年人在衰老过程中的脑萎缩。还需要钼,从而在成熟和成长过程中或在炎性肠病和/或食物变态反应过程中,形成恰当的(例如肠道的)屏障功能。
恰当量的钼意指超过2μg/kg体重/天的量,尤其是3-40μg/kgbw.d,更优选3.6-32μg/kgbw.d。这对于婴儿制品通常将获得2.0-40μg/100kcal[或0.48-9.5μg/100kJ],优选2.6-30μg/100kcal[或0.62-7.1μg/100kJ]的浓度,而对于成人产品将获得15-400μg/100kcal,优选18-100μg/100kcal,更优选24-40μg/100kcal[分别相当于3.6-95微克/100kJ,优选4.3-23.8微克/100kJ,更优选5.7-5.7微克/100kJ]的浓度。
对于体重80kg的人,每天食用的镁量应为400-1000mg,优选480-800mg。当设计完全营养时,获得的浓度为7.5-40mg/100kcal,优选9-30mg/100kcal,这等于1.8-9.5mg/100kJ,优选2.1-7.1mg/100kJ。镁似乎对于糖脂的充分生物合成很重要。
可包括另外的锌,用于多种目的,例如,为了使铜稳态正常化。为此,应当以超出铜的8-40倍,优选10-30倍的比例提供。铜稳态的正常化对于增大含铜血浆铜蓝蛋白的饱和程度和防止膜成分(包括APP或其部分)的过度氧化很重要。
具有平衡的矿物组成似乎很重要。这增强每个患者的效力并且还增加了在更大的患者组中的适用性。这方面的平衡是指应当包括如上所述的所有矿物,同时所指出的相对量对于形成恰当平衡也很重要。
这些矿物的合适来源包括带有有机或无机阴离子的它们的盐,如硫酸盐、碳酸盐、碳酸氢盐、氢氧化物、氯化物和柠檬酸盐。不应使用锰和钼的氧化物,尤其是在婴儿制品中。优选使用某些硫酸盐形式,以这样的方式即硫酸盐提供1-400mg/100g,优选2-250mg/100g,更优选3-125mg/100g产品。钼合适作为钼酸盐包括在内。
当产品中包括大量的钙或者在总日常饮食中使用高剂量的钙时,例如当在根据本发明的产品之后食用营养补充物时,似乎锰和钼的作用可被拮抗。因此,产品中钙对锰的量应为1-235:1,优选5-205:1,更优选10-100:1。
包括在产品中的蛋白成分超过80wt%并且优选90-100wt%必须是可消化的。蛋白成分包括完整蛋白、如可通过完整蛋白的水解以及通过合成而获得的肽、包括80%以上重量份的氨基酸的肽的衍生物、(天然存在的)氨基酸本身,和牛磺酸,以及所述氨基酸和牛磺酸的衍生物,如盐、N-酰化或N-乙酰化形式以及酯。甜菜碱、二甲基甘氨酸、肌氨酸、核苷类物质和胆碱也包含氮,但不作为蛋白计算。
蛋白质是由于提供可利用的半胱氨酸和/或牛磺酸的等价物。在食品制造中通常使用的所有蛋白都提供半胱氨酸。如果考虑乳制品(dairy)作为蛋白来源,则应当认识到酪蛋白是一种相对较差的半胱氨酸来源。因此,有利的是,至少部分地使用乳清蛋白,尤其是α-乳白蛋白或富含在α-乳白蛋白中的乳清蛋白,以便增加产品中的半胱氨酸水平。β-乳白蛋白的量,与在天然乳类中观察到的比率相比,其相对于α-乳白蛋白的量,优选为较低。
当使用乳类作为蛋白源时,优选使用蛋白成分,其也富含于蛋白质或肽(其高度糖基化)中,例如酪蛋白糖巨肽(CGMP)。这些蛋白/肽限定为那些肽,其中超过10%的氨基酸残基已被糖基化。用于包含在蛋白成分中的乳类成分中的CGMP的量优选高于20%,更优选超过35wt%,最优选超过40wt%。
优选地,该蛋白包含浓度为每100g蛋白2.5g,优选3.0-6g,更优选3.3-6g的组氨酸。这意味着当使用乳清蛋白达到显著程度时,需要包括游离组氨酸。
牛磺酸的量应为每日剂量超过0.1g,优选0.2-4g,更优选0.4-3g。通常这个剂量在液体产品中获得的浓度为每100g产品超过5mg,优选7-100mg,更优选9-60mg。牛磺酸盐也是合适的成分。
在上述脂质、矿物和蛋白成分之后,本发明的组合物优选包含其他成分,例如碳水化合物成分和/或核苷酸成分。而且,优选还包含维生素部分和/或甲基供体部分。
碳水化合物成分包括可消化的碳水化合物成分,其优选包括半乳糖和/或核糖来源。为了在具有较低的血糖生成指数(glycemicindex)的碳水化合物混合物中提供足够的能量,这些可利用和可消化的非葡萄糖糖类的量必须低于消费者可利用的葡萄糖的量的50wt%,优选10-40wt%。合适的半乳糖或核糖的来源是双糖,如乳糖或食品级别质量的合成单糖。尽管来自核苷酸的核糖有助于产品的生理作用,但是它在文献中不被计算为有助于总核糖含量,这是由于产品中核苷酸相对较低的剂量。
可消化碳水化合物成分有益地包括葡糖胺,如甘露糖胺和半乳糖胺或它们的N-酰化形式,例如N乙酰化形式,其量为可消化碳水化合物成分的0.1-10wt%,优选0.2-6wt%。
碳水化合物的一部分,尤其是2-50wt%可有益地是糖醛酸,如已在申请EP 5103247.2中描述的。寡聚糖的一部分(已在WO2005/027663中披露)对于如下提及的应用也是有效的,尤其是与所述蛋白成分和矿物成分一起使用时。
碳水化合物成分优选还包括肌醇来源。内消旋肌醇是优选的形式,尽管允许高达50%来自磷酸化形式,例如植酸等价物如植酸盐。磷脂酰肌醇似乎也是一种合适的备选。
每天给予体重80kg的个体的肌醇等价物的量应为0-1500mg,优选320-1200mg,更优选380-1100mg并且最优选420-1000mg。当计算体重4kg的婴儿期望的日用剂量时,得到21-50mg。
有益地包括在制品中的其他成分包括核苷酸源。核苷酸源是在食用后导致体内黄嘌呤、核苷酸、核苷和/或核酸碱基的组织水平升高的那些成分。合适的成分包括核酸碱基,如尿苷、胞苷、腺嘌呤、鸟嘌呤、胸苷、它们的磷酸化形式,尤其是单磷酸化形式如单磷酸尿苷,以及腺苷和鸟苷、核苷和核苷酸。
尽管可通过给予单一核苷酸源,尤其是单磷酸尿苷(UMP)而观察到有益效果,但是,对于所述组合物的组分,大约相当的良好作用,同时没有不期望的副作用危险,可通过使用核苷酸、核苷或核酸碱基的混合物而获得。这样的混合物优选从酵母或动物组织中提取。
当使用UMP作为来源时,对于体重80kg的个体的每日剂量必须为0.08-3g,优选0.1-2g,更优选0.15-0.9g。基于体重的所需等价物的剂量可通过采用等摩尔量的核酸碱基并校正为分子量,利用UMP的分子量(约324道尔顿),由UMP的剂量计算得到。
尿苷衍生物如UDP,其可很容易从饮食UMP形成,对于细胞内的糖蛋白和糖脂的转运及其在胞浆(细胞溶质)和质膜内的可利用度显得很重要。
维生素成分(如果存在)应该优选包括视频级别形式的维生素B6,其能够在体内增加肝和/或脑内磷酸吡哆醛的水平。这意味着对于体重80kg的个体,维生素B6的每日剂量被限制为每天不超过50mg,优选不超过25mg。对这样的个体来说,有效剂量是2-50mg,优选2.4-40mg,较优选8-25mg的维生素B6。对于体重不同的个体,最适剂量可通过采用成比例部分而计算。例如,对于体重3kg的婴儿,最适剂量是37-1875μg。优选的维生素B6的形式是吡多胺、吡哆醛、3-酰化吡哆醛类似物或其盐,如在US6 586414、US6548519和US 6339085(均结合于此供参考)中所披露的。
维生素成分进一步可包括生物素、叶酸盐和维生素B12。
所包含生物素的量应该大于1.5μg/kgbw.d,优选4-50μg/kgbw.d,更优选5-40μg/kgbw.d。对于成人,这通常导致产品中生物素的浓度大于6μg/100kcal,优选7-60μg/100kcal,较优选8-40μg/100kcal,而对于婴儿则为>3μg/100kcal,优选4-50μg/100kcal,更优选4.6-30μg/100kcal。生物素的恰当来源在本领域中是已知的。
叶酸包括叶酸、亚叶酸、甲基化、亚甲基化和甲酰基化形式的叶酸、它们的盐或酯,及其具有一个或多个谷氨酸的衍生物,和所有的还原或氧化形式。对于体重80kg的成人,如果计算为叶酸量,此量应该为至少300μg,优选420-2000μg,更优选520-1500μg/日剂量。对于婴儿,每kg体重建议的叶酸量比成人稍高。其应该>10μg叶酸/kgbw.d,优选30-140μg/kgbw.d,更优选45-120μg/kgbw.d。
制品的一个优选实施方式包括维生素B12。特别地,该维生素B12不是(氰)钴胺素,而是一个选自羟基钴胺素或甲基钴胺素的成员或者如WO 02/087593中披露的硫醇钴胺素(thiolatocobalamines)或如US 6187761所披露的提取物中之一。
其他维生素例如维生素A、D、E、K、C、B1、B2、B3和泛酸以及矿物质和痕量元素,例如Na、K、Ca、Fe、Cu、Se、I、F符合营养需求的常规推荐,特别是在婴儿制品中。
此外,甲基供体优选包含于根据本发明的产品中。当在哺乳动物体内被吸收时,甲基供体能够产生至少一个甲基。恰当甲基供体的实例包括甜菜碱、胆碱、丝氨酸、二甲基甘氨酸和肌氨酸。为了得到有效的结果,优先选择甜菜碱或二甲基甘氨酸。当蛋白源包含20wt%以上的植物源蛋白,例如来自谷类(如小麦、燕麦、大米、玉米或大豆)、或者种子/根茎类如豌豆、白羽扇豆、土豆或蚕豆的蛋白时,在产品中包括额外的甲基供体的优点变得尤其明显。这些产品中的有效剂量大于0.18mmol/kg体重/天剂量,优选0.19-2mmol/kgbw.d,更优选0.2-1.2mmol/kgbw.d。为了标准化,如果将人体重设为70kg,这将意味着胆碱(或二甲基甘氨酸,因为其具有几乎相同的分子量)应该以大于1.3g/2L产品的浓度在液体组合物中存在。成人食用者所用液体补充物(量为400ml/d)则将包含1.3g/400ml。
没有将来自磷脂的胆碱计算为对甲基供体量的贡献。
相比于甲基供体的量,如果产品中的甲基受体的量保持较低,则用一种或多种甲基供体进行的强化特别有益。特别地,相比于甲基受体(例如甘氨酸、磷脂酰乙醇胺,和多胺如精胺及亚精胺)的摩尔量,具有超出3倍以上摩尔量的甲基供体是有利的。
此外,那些产品中可以有益地包含他汀类,所述产品可为患血脂异常,特别是高胆固醇血症的患者使用。在设想血浆胆固醇水平迅速降低的情况下,混合物在短于2周的时间内将比较有用。在此期间,所述化合物可增加本发明的组合物的效力。然而,较长时间包含诸如辛伐他汀、洛伐他汀、罗苏伐他汀、普伐他汀、氟伐他汀和阿伐他汀的化合物的不利之处在于它们能够强烈抑制羟甲基戊二酰CoA还原酶(当给予相对较小量时)的能力。因此,如果该产品长期与他汀类一起给予,则该产品应该包含由泛琨、泛醇、维生素K2(menaquinons)、辅酶Q10、多萜醇、多萜醇酯、多萜醇醚、合成的聚类异戊二烯(含8个以上类异戊二烯单元,例如带有一个或多个羧酸基团的类异戊二烯)、具有类视黄醇的羟基、番茄红素和固醇组成的组中的一种或多种,其量应足以抵消给予他汀类的不利之处。优选包含多萜醇或其类似物,其中所述多萜醇类似物分子的至少80%基本为非极性。允许最多15%,但优选少于10%的碳原子可为极性基团,例如羟基、烷氧基(特别是甲氧基)、羧基、巯基、取代巯基、氨基、取代氨基、烷基或酰基部分所取代。
要求这些包含物保持产品作为如癌症患者的免疫功能改进剂,特别是作为降低对转移灶形成的敏感性的产品的效力。如果与他汀类疗法联用,则该产品如果在没有权利要求1中所述产品的蛋白和矿物成分的情况下使用,仍显得有益,前提条件是包含上文提及的组分,含量为每日剂量至少20mg多萜醇类似物、至少4mg类视黄醇、至少4mg泛琨、泛醇、维生素K2以及至少0.02mg固醇。恰当的固醇特别是指如在哺乳动物有机体中存在的天然固醇。
效果
根据本发明的产品可使神经细胞的膜功能正常化,特别是当这些膜发生变形和/或具有不当的组成时。尽管人们可以推测这些缺陷的原因,但似乎是一种或多种的膜结合酶的功能失常,例如鞘磷脂酶的上调(其降低(神经)鞘磷脂含量并增加神经酰胺水平)似乎对该病症比较重要。而且,暴露于大量的应激原、遗传倾向和/或慢性营养不良可能促进较迅速形成所赋予的神经功能。
由于衰老以及非最适营养,年龄大于50岁的人特别易于患这种疾病。大量膜变形的神经细胞的存在将导致例如认知功能、感觉意识的减退以及不足以控制运动系统(肌肉)的能力。膜变形的神经细胞将开始合成增加量的Aβ(Abeta)蛋白,其诱发淀粉样沉着物,形成斑块和/或神经原纤维缠结。变形的膜还将开始成为几种亲脂化合物(例如几种在这种基质,例如Aβ、特别是Aβ42的二聚体中可溶的肽)的宿主,这可能导致凋亡信号释放并引起神经细胞死亡。
最后,这可能导致脑体积特别是白质的体积萎缩,尤其是在非常老的患者中。由这些效应引起的综合症为通常所知的痴呆或阿耳茨海默(氏)病,尽管已经描述了这些疾病的具体形式。
神经病变部分地是在其中生物体特别是神经组织较长时间暴露于水平增高的还原性等价物,特别是氢化烟酰胺腺嘌呤二核苷酸(NADH)的情况下引起的。这样的水平在例如经受胰岛素抵抗如糖尿病的个体、经受局部贫血(例如手术后或者经受了可将血流量提供给组织的其他生理性创伤)的个体或者酗酒的个体中有所增加。
人们可以区分发生于中枢(脑和脊髓)的神经病变以及周围神经病变。根据本发明的组合物在两种类型的神经病变中均有效。中枢胰岛素抵抗可能引起诸如阿耳茨海默(氏)病或帕金森病的神经病变。周围神经病变可赋予运动和感觉功能和/或引起疼痛,如下文所阐释的。这种神经病变还可包括特殊器官如肝内的神经功能。不希望受到理论限制,但根据本发明的组合物可降低细胞溶质唾液酸酶活性并增加神经细胞必要组分(包括硫苷脂类和神经节苷脂)的生物合成速率,这可能比较重要。
由于抗体袭击引起的神经病变似乎也有所降低。不希望受到理论限制,但在这种类型的患者中,施万型细胞功能的改善(特别是关于修复受损的髓磷脂和细胞碎片的功能),如同血-神经屏障完整性的改善以及脊髓中神经胶质细胞活化状态的降低一样,促进了该效应,这可能比较重要。这使得本发明的组合物在多发性硬化症的治疗以及慢性或神经性疼痛(与正常疼痛相对)的减退中是有益的。
给予根据本发明的组合物似乎可改善神经细胞之间的相互作用,该效应对于身体对外界诱因(刺激)的多种反应均具有重大的影响。例如,改善了对感觉诱因的恰当注意和处理以及作为对这些诱因的反应而对运动功能的充分限定。相互作用(包括阈功能)对于思考过程和情绪的感知,包括恐惧和疼痛感是必要的。
此外,多种器官和/或细胞恰当发挥作用,其至少部分地受迷走神经控制或者对由上皮细胞和巨噬细胞释放的局部乙酰胆碱发生反应,其依赖于神经细胞恰当处理这些信号的能力。这些反应的实例包括对膳食成分形成感觉意识后的胃肠道活性以及心脏在静息状态(心律不齐)和锻炼过程中的活性。另一个实例是免疫系统的活性,特别是在血液、淋巴中循环的免疫细胞的活性,尤其是肺和胃肠道上皮细胞内的免疫细胞的活性。这些细胞包括产生粘液(杯状细胞)和多糖蛋白质复合物的细胞、抗原提呈细胞、Paneth细胞和Peyer氏斑、以及淋巴细胞(如局部存在于固有层中的淋巴细胞)的活性,均受到它们的膜组成和功能的强烈影响。
中枢神经系统(包括自主神经系统和下丘脑)功能的改善包括白质的功能化,并导致更好的思维能力,增强的情感、沟通技能和记忆功能。
发明者称,除了神经递质释放和受体功能(尤其是G蛋白受体),神经细胞的膜组成也得到了改善,特别是极性脂类组分如硫苷脂、神经酰胺、(神经)鞘脂类、糖蛋白和糖脂相对于膜的总质量和/或相对于非极性成分的量的含量。非极性化合物的实例是胆固醇和二聚肽,特别是较大膜蛋白(如淀粉样前体蛋白)的同源非极性二聚肽的量,更尤其是Aβ-42片段的二聚体形式的量。以这种方式,其目的在于改变膜筏的大小和组成并保持筏活性部分的恰当功能。这样,不仅受体的功能发生改变(这可能是由于用于该受体的配体分子亲和性发生变化和区分能力下降,或者例如通过影响第二信使如IP3通路而改变配体的固有活性);而且糖蛋白和膜结合酶的活性也发生了变化。以这种方式,可实现活细胞的代谢和生理活性的显著变化。这特别适用于神经细胞、免疫细胞、骨髓细胞、干细胞和血细胞如红细胞的功能化。本发明的发明人发现,通过给予根据本发明的组合物可改善乙酰胆碱的生物合成和转运。膜结合胆碱乙酰转移酶(ChAT)的功能得到改善,并且其在囊泡膜上转运入突触间隙也得到了改善。乙酰胆碱释放是脑功能的一个必要部分,其包括认知功能以及副交感神经系统特别是迷走神经的活性。神经系统的该部分调节胃肠道行为,以及例如心脏节律。通过给予本发明的组合物,可实现心律不齐、消化道动力和消化道介导的全身免疫反应的改善。
根据本发明的组合物对于受损神经组织的修复也非常有用。神经损伤可发生于创伤例如手术或脊髓损伤后,还可发生于慢性暴露于高舒张压后的脑内。
根据本发明的组合物在多发性硬化症的治疗中比较有用。脱髓鞘过程减慢,并形成脑内的脱髓鞘斑。
在患有帕金森病特别是原发性帕金森病(PD)的患者中,根据本发明的组合物可降低黑质细胞的退化速率。特别地,在PD患者以及患特殊形式痴呆如Lewy体痴呆或患多系统萎缩症(MSA)和肌萎缩性(脊髓)侧索硬化(ALS)的患者,淀粉样蛋白斑的量以及脑内α-突触核蛋白(α-synuclein)和Lewy体的量将降低。
这种过量蛋白在脑特别是神经元和神经胶质细胞内的沉淀,例如亨廷顿氏病过程中出现的聚谷氨酸积聚以及多种形式的痴呆、瘫痪和皮质延髓变性中的tau-蛋白,均可通过根据本发明的组合物的干预而很方便地被抵消。细胞内膜例如高尔基体和/或内质网膜的改变以及随之发生的蛋白不同修饰在形成该效应中可能也发挥了作用。
当用来给予患胰岛素抵抗的患者以及给予婴儿或幼儿时,重要的是包含可增加胰岛素敏感性的组分,例如蛋白成分,其包含所有必需氨基酸,且具有相对较高的天冬氨酸/谷氨酸比值,特别是高于0.42,优选0.44-0.8,较优选0.45-0.6,或者维生素成分,其至少包含核黄素等价物、维生素B6和/或生物素或者优选包含所有这三种维生素。这种蛋白成分的实例包括α乳白蛋白或已经加入天冬氨酸的蛋白混合物。
在将所述组合物给予糖尿病患者的情况下,将该组合物作为二甲双胍的佐剂给予而避免与已知会降低胰岛素敏感性的药物同时给予,是更加有益的。对于患胰岛素抵抗的患者,进一步优选包含纤维或含抗性淀粉的纤维样物质,占所述组合物中的纤维混合物的20wt%以上。并且对于糖尿病和肥胖个体,包含纤维样物质,例如可缓慢消化的淀粉、乳糖低聚糖、纤维素或果糖低聚果糖/低聚果糖是有好处的,对于这些患者,建议淀粉含量达约30wt%或更多。
根据本发明的组合物中的活性组分还可在胚胎发育过程中调节眼和脑的成熟。因此,根据本发明的组合物可用来给予孕妇,用于形成婴儿的良好视觉和脑功能,包括认知能力和心理素质(精神能力)。
改善的神经细胞之间的通讯在抗癫痫性惊厥方面、降低精神分裂症的频率和强度、在降低患抽动秽语综合征个体的发作率、减少ADHD和自闭症行为以及改善睡眠行为方面显得比较重要。
为了对抗这些疾病中的急性情形,应将根据本发明的组合物包含于生酮饮食中。特别地,根据本发明的营养产品的热价(热值)必须大于该产品中蛋白、脂质和可消化碳水化合物的热价的40%,优选该量大于46%,更优选大于50%。在这种生酮产品中,脂质成分必须符合上述标准。ω-6长链多不饱和脂肪酸的量应该相对较低,而饱和脂肪酸的量应该相对较高。
存在于根据本发明的组合物中的活性组分似乎对于消化道的恰当成熟及其屏障、免疫和转运功能的恰当发育是必要的。在已患这种消化道疾病的个体中,该效应变得比较明显,包括对肠道感染的敏感性降低、腹泻和细菌过度生长的速率下降以及对食源性变应原的敏感性较低。
不希望受到理论限制,人们认为根据本发明的产品可改善上皮细胞的膜功能、受体如CD1d受体的功能并且它们增强树突细胞的恰当作用,这是比较重要的。这种恰当作用包括释放趋化因子和细胞因子,其补充适当类型的淋巴细胞、提供恰当的“Th1/Th2”反应并指导这些细胞恰当迁移至淋巴结。这些效应降低了病原体易位和病原体识别的速率。人们认为补充适当类型的T细胞有助于对抗不需要的细胞如变应原、病原体和突变细胞,并确定恰当的反应,比如对于有机体的变态反应。由于例如内皮细胞的质膜组成发生改变,病原体和/或变应原特别是包含疏水部分的变应原粘附更少和/或差异地粘附,这引起更为恰当的反应。此外,上皮细胞产生的粘蛋白的组成,特别是与硫酸化和唾液酸化组分的量相关的组成将得以改善。
为了获得消化道疾病最大程度的改善,特别是在营养不良的患者中,根据本发明的组合物应该包含胆固醇源。特别地,含量必须在2-100mg/100g,优选6-60mg/100g,最优选9-40mg/100g的范围内。恰当的来源是游离胆固醇或胆固醇酯(特别是含油酸的胆固醇酯)或者它们的混合物,优选游离胆固醇与酯化胆固醇的比值为4-10:1。
还认为,上文提及的与免疫系统相关的效应还与改善对促炎症反应诱因的反应以及降低自身免疫反应强度有关。这似乎适用于慢性炎性疾病特别是关节炎、肝炎、胰腺炎和慢性支气管炎的治疗,以及易患I型糖尿病的小婴儿和表现为患类风湿病如类风湿性关节炎和多发性硬化症的老年人的治疗。
根据本发明的组合物有利于肺发育和肺组织在例如烧伤、暴露于毒剂、肺气肿和慢性身体暴露如慢性咳嗽之后以及在炎症和相关肺感染的过程中及作为肺阻塞性疾病如COPD和支气管炎导致的肺组织修复。
肺组织包含大量特殊的表面活性分子,可由本发明的组合物增加其生物合成速率。该组合物用于孕妇以改善胎儿肺发育、对胎龄较小的婴儿特别是对呼吸窘迫综合征敏感的婴儿非常有用。肺发育问题可通过在恰当的时刻比如妊娠6个月后分析羊水的组成,特别是(神经)鞘磷脂相比于其他脂质组分的量而鉴别。
当提供给患者用于改善肺功能时,脂质成分应该包含相对较大量的软脂酸(C16:0),特别地,多于总脂质成分中脂肪酸的10wt%,更特别地是10.5-18wt%。在甘油三酯成分中,软脂酸应该优选具有15%以上的sn2位置。
根据本发明的制品在COPD治疗中的效力可通过测定指示呼吸能力的参数如FEV 1.0和/或测定不同类型毒蕈碱受体的表达以及痰细胞的趋化因子分泌(如在Profita M.,et al.(Allergy,2005,60:1361-1369)中所披露的)而形成。
根据本发明的组合物改善对体内所不需要的细胞例如突变或肿瘤细胞的识别,并改变由通过抗原刺激的巨噬细胞的细胞因子生产模式。因此,它们减少患肿瘤的风险,并降低肿瘤在切除或用其他方式如放疗或化疗破坏后的复发率,以及降低转移灶形成率。
细胞膜的组成和结构似乎可在例如形成对胰岛素敏感性的过程中影响细胞内的还原性等价物的转运。因此,根据本发明的组合物减小了儿童期以及成人期发生肥胖的倾向。
在抗肥胖时,所述组合物似乎降低循环性C反应蛋白(CRP)的量并降低通过脂肪组织的CRP释放。增加了通过脂肪组织的抵抗素的内源性合成。以这种方式,可降低代谢综合征患者发生心血管病的几率,尤其是肥胖个体发生动脉硬化和高血压的几率。
特定器官和细胞器的内分泌功能(包括胰腺、下丘脑以及肝内细胞器Golgi和ER的功能,并包括神经细胞内囊泡的生物合成以及内分泌信使从中释放)有所改善。公开了根据本发明的组合物有助于胰腺释放胰岛素、囊性纤维变性患者分泌消化酶、垂体对信号(其到达身体其他部位或由身体其他部位产生)的恰当反应以及免疫功能,特别是枯否氏(Kupffer)细胞的清除功能以及可生产急性期蛋白的器官的生物合成作用。
为了如上文提及的目的,该组合物可有益地与几种类型的药物联用。该产品与较大平面分子如他汀类的联合应用上文已经论及,特别是与患有血脂异常的老年人认知障碍的治疗有关的应用。通常,这些患者中相对较大部分具有相对较大量的斑点和缠结。
如果目标在于改善认知功能,特别是当药物使用时间短于约1个月以及当该时期内抑制剂的剂量低于10mg/天(对成人则优选低于2mg/天)时,则本发明的组合物可有益地与磷酸二酯酶抑制剂联用。
根据本发明的产品还可有利地与淀粉样蛋白形成的疫苗疗法联用或作为其佐剂。脑内淀粉样蛋白量的快速下降通过较好膜的生物合成而支持,从而防止残余的过量淀粉样蛋白的有害作用。
通常在所述组合物的效果表现出来之前至少需要几天时间,最佳结果可通过在人类应用能达到每日使用该产品且超过1周(特别地,超过2周)的给药方案而获得。所述给药方案可包括加载期,其中在第一周期间给予2或3个日剂量,其后则必须应用文献中披露的日剂量,以获得最佳结果。
实施例
实施例1
引言
在阿耳茨海默(氏)病患者中,其中一个标志是存在β淀粉样蛋白(Aβ)斑。A β斑的形成引起乙酰胆碱(一种与学习和记忆过程相关的神经递质)产生能力的下降。乙酰胆碱水平的下降造成记忆丧失[Isacson,2002 #766]。用含A β的溶液注射大鼠引起类似的学习和记忆问题[Nakamura,2001 #621]。该模型为人们普遍接受用来检测有益化合物对A β所诱导的记忆丧失的作用。该实验论证A β输注对乙酰胆碱产生细胞和乙酰胆碱的运载体的作用。此外,采用一种饮食组合物预防这些作用。
实验设计
四组大鼠接受β淀粉样蛋白或盐水溶液输注入心室外侧。输注前5周,用两种饮食之一,A或B饲喂大鼠。表1中总结了所述4个组。表2列出了两种饮食的饮食组成。饮食A作为对照饮食,饮食B富含DHA、EPA和磷脂,以改善膜的质量。此外,其富含UMP和胆碱,以刺激膜合成。并且其富含B-维生素和叶酸以降低高半胱氨酸水平。
表1:输注溶液和饮食不同的大鼠分组
表2:饮食组成
结果
表3(和图1)列出了Aβ输注和饮食干预对乙酰胆碱产生和转运能力的作用(影响)。饮食A饲喂大鼠的A β输注导致乙酰胆碱产生细胞(ChAT)减少,并导致乙酰胆碱转运能力(VAChT)下降。饲喂饮食B则完全将乙酰胆碱的生成和转运能力恢复为正常水平。
表3:ChAT和VAChT的结果
讨论和结论
心室外侧输注A β可引起乙酰胆碱生成和乙酰胆碱转运能力下降。这些作用通过饲喂富含ω-3脂肪酸、磷脂、B-维生素和UMP/胆碱的饮食而完全消失。
实施例2
即用型液体产品,用于改善年龄50岁以上的个体的认知功能,每100ml提供:
能量50-120kcal;蛋白质1-10g;脂质1-5g;可消化碳水化合物4-20g,且包含
a-DHA+DPA+EPA=1000-2000mg
b-30-280mg 半胱氨酸或牛磺酸
c-100-1000mg 磷脂
d-0.5-3mg 维生素 B6
e-50-500ug 叶酸
f-1-30ug 维生素 B12
g-0.07-2mg 锰
h-0.07-2mg 钼
实施例3
用于阿耳茨海默(氏)病患者的即饮型液体,每100ml包含
能量 100kcal
蛋白质 3.06g(酪蛋白,乳清 80/20)
碳水化合物 13.3g(糊精-麦芽糖复合剂,蔗糖)
脂肪 3.73g(鱼油,磷脂)
包括0.96g DHA和0.24g EPA
一磷酸尿苷 0.5g(二钠盐)
胆碱 0.32g
维生素E 32mg α生育酚
维生素C 64mg
硒 48μg
维生素B6 0.8mg
叶酸 0.32mg
维生素B12 2.4μg
镁 20mg
锌 1.2mg
锰 0.3mg
钼 10μg
还包括0.12g Na、0.15g K、0.12g Cl、80mg Ca、70mg P、1.6mg Fe、13.3μg I、0.18mg Cu、6.7μg Cr、0.1mg F、0.16mg vitA(维生素A)、0.15mg B1、0.16mg B2、1.8mg B3、0.53mg B5、0.7μg D、4.0μg生物素和5.3μg维生素K。
实施例4
粉末状抗变应性婴儿制品,按15.4g粉末/100ml水新鲜重制后,可提供:
能量 64-80kcal
蛋白成分 1.0-2.0g 排他性地基于游离氨基酸或其盐,且其
包括至少2wt%半胱氨酸和0.2wt%牛
磺酸
脂质 2-4g 其提供2wt%基于脂肪酸总和的DHA
成分包括5-40wt%酪乳脂肪和0.5-8
wt%蛋类脂质(包括卵磷脂)
核苷酸等价物 1-40mg UMP与酵母抽提物的混合物
锰 65-1000μg 以盐的形式特别是MgSO4包含在内
钼 2.3-300μg 以盐的形式特别是钼酸盐包含在内
胆碱等价物 20-200mg 以胆碱盐的形式特别是酒石酸氢胆碱包含在内
在该实施例中,确定所包括的其他组分,如Na、K、Cl、Ca、P、Fe、Cu、Zn、Se、Cr、I、vit A、D、E、K、B1、B2、B3、B5、B6、B12、B11、生物素和C的量遵循用于婴儿制品的建议。还包括肌醇。
实施例5
用于免疫功能低下患者的产品
即用型液体产品,每100ml包含
能量 630kJ(或110kcal)
蛋白质 4.0g(酪乳乳清/酪蛋白 20-80)
碳水化合物 12.4g(3g乳糖,糊精-麦芽糖复合剂,可
缓慢消化的淀粉)
脂质 5.3g(1g乳脂,1g水产动物油,0.6g蛋类脂
质,2.7g植物油)
锰 1mg
钼 0.1mg
甜菜碱 100mg
纤维 1.0g(抗性淀粉,半乳低聚糖 50/50)
Na 0.1g、K 0.2g、Cl 0.13g、Ca 0.8、P 0.8、Mg 50mg、Fe 2.4mg、Zn 2.4mg、Cu 0.3mg、F 0.15、Se 8.6μg、Cr 10μg、I 20μg、vit A 0.12mg RE、D 1.1μg、E 1.6mg TE、K 8μg、B1 0.23mg、B20.24mg、B3 2.7mg NE、泛酸 1.0mg、B6 0.8mg、B11 80μg、B120.4μg、生物素 10μg、C 12mg
实施例6
用于患癌症、HIV、进行骨髓移植、心脏衰竭或COPD患者的产品
即用型液体组合物,基于全脂巴氏灭菌绵羊或骆驼乳,每100ml包含
0.4g藻油、0.4g甜菜碱、0.4g核糖和0.2g组氨酸,还包括Na 50mg、K 160mg、Cl 100、Ca 150mg、P 120mg、Mg 52mg、Fe 3mg、Zn 2.8mg、Cu 0.4mg、Mn 3mg、F 0.2mg、Mo 200μg、Se 11μg、Cr 13μg、I 25μg、维生素A 188μg RE、D 1.3μg、E 2.3mg a-TE、K 10μg、B1 0.3mg、B2 0.3mg、B3 3.4mg NE、泛酸2mg、B6(作为吡哆醛)0.6mg、叶酸100μg、B12 0.7μg、生物素7.5μg和二甲基甘氨酸80mg。
实施例7
用于预防肥胖的产品
液体产品,每100ml包含
能量 336kJ
蛋白质 4.0g(3.6g大豆蛋白分离物、0.2g天冬氨酸、0.2
g组氨酸)
脂质 4.0g(多萜醇0.2g,磷脂1g,乳球膜富集的脂
肪成分0.6g,水产动物油1.0g,菜籽油0.5g,向
日葵0.7g,玉米油0.5g)
碳水化合物 12g(乳糖2g,糊精-麦芽糖复合剂6g,可缓慢
消化的淀粉2g,2g蔗糖)
锰 1mg
钼 0.1mg
甜菜碱 100mg
纤维 1.0g(抗性淀粉,半乳低聚糖 50/50)
Na 0.1g、K 0.2g、Cl 0.13g、Ca 0.8、P 0.8、Mg 50mg、Fe 2.4mg、Zn 2.4mg、Cu 0.3mg、F 0.15、Se 8.6μg、Cr 10μg、I 20μg、vit A 0.12mg RE、D 1.1μg、E 1.6mg TE、K 8μg、B1 0.23mg、B20.24mg、B3 2.7mg NE、泛酸 1.0mg、B6 0.8mg、B11 80μg、B120.4μg、生物素 10μg、C 12mg。
实施例8
用于患神经病变的糖尿病患者的即用型液体产品,每100ml包含
蛋白质 4.75g(豌豆蛋白,酪乳乳清)
脂质 3.78g(包含20%较小脂肪球的绵羊乳脂肪成分
0.4g,蛋类脂质1g,植物油1.98g和
0.4g水产动物油)
碳水化合物 11.75g
半乳糖 1.5
帕拉金糖 3.0
缓慢消化淀粉 1.0
果糖 0.2
糊精-麦芽糖复合剂 3
葡萄糖 2
异麦芽糖低聚糖 1.05
纤维 2.0g
半乳低聚糖 1.0
抗性淀粉 0.6
纤维素 0.1
聚果低聚果糖/低聚果糖 0.3g
面包酵母 0.3g
根据实施例2的维生素、矿物质。
实施例9
用于孕妇的产品
蛋白质 3.06g(酪蛋白,乳清 80/20)
碳水化合物 13.3g(糊精-麦芽糖复合剂,蔗糖)
脂肪 3.73g(鱼油,来自绵羊乳的富含糖脂成分)
含0.96g DHA和0.24g EPA
一磷酸尿苷 0.5g(二钠盐)
二甲基甘氨酸 0.6g
维生素E 12mg α生育酚
维生素C 24mg
硒 38μg
维生素B6 0.8mg
叶酸 0.32mg
维生素B12 4.4μg
镁 30mg
锌 1.5mg
锰 0.3mg
钼 20μg
还包括0.12g Na、0.15g K、0.12g Cl、80mg Ca、70mg P、1.6mg Fe、13.3μg I、0.18mg Cu、6.7μg Cr、0.1mg F、0.16mg vitA、0.15mg B1、0.16mg B2、1.8mg B3、0.53mg B5、0.7μg D、4.0μg生物素和5.3μg维生素K。二甲基甘氨酸半乳糖。
Claims (20)
1.一种脂质成分在制备一种组合物中的应用,所述脂质成分包含二十二碳六烯酸(DHA)、二十二碳五烯酸(DPA)和二十碳五烯酸(EPA)中的至少一种,以及尿嘧啶来源,所述组合物适合用于婴儿或儿童的营养品并用来改善神经系统或肺组织的生长和发育或者治疗受损神经细胞。
2.根据权利要求1所述的应用,其特征在于所述组合物进一步包含提供半胱氨酸和/或牛磺酸的蛋白成分以及包括锰和钼中的至少一种的矿物成分。
3.根据权利要求1或2所述的应用,其中,所述组合物进一步包含选自由核酸碱基,如胞嘧啶、腺嘌呤、鸟嘌呤、胸腺嘧啶;它们的磷酸化形式(核苷酸),特别是单磷酸化形式;以及它们的核苷,特别是腺苷、胞苷、胸苷和鸟苷组成的组中的至少一种化合物。
4.根据权利要求1、2或3所述的应用,其中,所述组合物提供1-37.5mg或3.08-115.7mMol尿嘧啶/kg体重/天(包括游离尿嘧啶、尿苷、UMP、UDP、UTP和/或包含尿嘧啶部分的另一种化合物)。
5.根据权利要求1、2或3所述的应用,其中,所述脂质成分还包含ω-6长链多不饱和脂肪酸(具有的碳链长度为18或更长),其含量占所述脂肪酸的8-30wt%。
6.根据权利要求1、2、3或4所述的应用,其中,所述脂质成分包含大于0.01wt%的糖脂类化合物的组中的至少一种组分,特别是选自神经节苷脂、硫苷脂和鞘磷脂的组的至少一种组分。
7.根据权利要求1-5所述的应用,其中,所述组合物进一步包含可消化碳水化合物成分,优选半乳糖和/或核糖来源。
8.根据权利要求1-6所述的应用,其中,所述组合物包含的脂质成分至少部分地来自乳制品、来自蛋类、或者来自植物种子或豆类的胚乳。
9.根据前述权利要求中任一项所述的应用,其中,所述脂质成分包含大小为0.001-10μm的脂肪球。
10.根据前述权利要求中任一项所述的应用,其中,所述脂质包含1.3-16wt%的磷脂和/或0.1-20wt%的糖蛋白和糖脂。
11.根据前述权利要求中任一项所述的应用,其特征在于所述组合物包含的蛋白成分中天冬氨酸与谷氨酸的重量比至少为0.42。
12.根据前述权利要求中任一项所述的应用,其特征在于所述组合物包含植物蛋白和/或大于0.18mmol/天的甲基供体。
13.根据前述权利要求中任一项所述的应用,其特征在于所述组合物包含4-15mg内消旋肌醇。
14.根据前述权利要求中任一项所述的应用,其中,所述组合物用于治疗脑瘫。
15.根据前述权利要求中任一项所述的应用,其中,所述组合物用于促进心理发展或消化舒适。
16.根据前述权利要求中任一项所述的应用,其中,至少一部分的尿嘧啶是以一种或多种核苷酸的形式提供,特别是以UMP形式提供。
17.用于改善老年对象的认知功能的组合物,所述组合物具有能量含量为50-120kcal,蛋白含量为1-10g,脂质含量为1-5g,以及可消化碳水化合物的含量为4-20g,所述组合物包含
a) 1000-2000mg DHA+DPA+EPA
b) 30-280mg半胱氨酸或牛磺酸
c) 100-1000mg磷脂
d) 0.5-3mg维生素B6
e) 50-500μg叶酸
f) 1-30μg维生素B12
g) 0.07-2mg锰;以及
h) 0.07-2mg钼。
18.粉末状抗变应性婴儿制品,按15.4g粉末/100ml水新鲜重制后,包含的能量含量为64-80kcal,以及:
1.0-2.0g的蛋白成分,其排他性地基于游离氨基酸或其盐,且其包含至少2wt%半胱氨酸和0.2wt%牛磺酸;
2-4g的脂质成分,其基于脂肪酸的总和包含2wt%的DHA,其中所述脂质成分包含5-40wt%酪乳脂肪和0.5-8wt%的包括卵磷脂的蛋类脂质;
1-40mg的核苷酸成分,其包含UMP与酵母抽提物的混合物。
76.3-1300μg的矿物成分,包括65-1000μg以盐形式特别是MgSO4包含在内的锰,以及2.3-300μg以盐形式特别是钼酸盐包含在内的钼;以及
20-200mg以胆碱盐的形式特别是酒石酸氢胆碱包含在内的胆碱。
19.根据权利要求1-16中所限定的组合物在改善哺乳动物细胞的功能中的应用,所述哺乳动物细胞选自由神经细胞、免疫细胞、干细胞、骨髓细胞和红细胞组成的组。
20.根据权利要求1-16中任一项所限定的组合物在预防哺乳动物肥胖中的应用。
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CNA2006800527013A Pending CN101370396A (zh) | 2005-12-23 | 2006-12-22 | 用于改善膜组成的包括多不饱和脂肪酸的组合物 |
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CNA2006800524072A Pending CN101370491A (zh) | 2005-12-23 | 2006-12-22 | 用于改善膜组成的含有多不饱和脂肪酸、蛋白质及锰和/或钼的组合物 |
CN201710513954.6A Pending CN107495379A (zh) | 2005-12-23 | 2006-12-22 | 含有多不饱和脂肪酸、蛋白质及锰和/或钼的组合物 |
CN2006800533029A Active CN101384184B (zh) | 2005-12-23 | 2006-12-22 | 用于预防肥胖症的婴儿营养组合物 |
CN2006800513063A Expired - Fee Related CN101389227B (zh) | 2005-12-23 | 2006-12-22 | 预防肥胖的婴幼儿营养组合物 |
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CNA200680051656XA Pending CN101400344A (zh) | 2005-12-23 | 2006-12-22 | 用于改善细胞的膜组成和功能的组合物 |
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