CN101370396A - 用于改善膜组成的包括多不饱和脂肪酸的组合物 - Google Patents
用于改善膜组成的包括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种疾病危险的人给药一种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:a/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)中的至少一种;b/蛋白质成分,包括来自非人源的提供至少半胱氨酸和/或牛磺酸的蛋白质类物质;以及c/矿物质成分,包括锰和钼中的至少一种。哺乳动物细胞的多种类型的膜功能得到改善,这允许有效治疗免疫相关失调,如变应反应、自身免疫疾病、癌症、认知功能障碍和神经系统的其它疾病,神经病变例如糖尿病性神经病变和神经性疼痛、胰岛素抵抗期间的神经元损伤,以及肠道疾病,并支持在成长或恢复期间的肠道和肺功能的形成。
Description
技术领域
本发明涉及保健和药物组合物,更特别地,涉及能够改善细胞的膜组分和功能并能够通过其改善整个细胞功能的组合物。
背景技术
已知活细胞的膜具有多种重要的功能。质膜充当对细胞外组分(例如,化合物、抗原和细胞)的屏障;膜(细胞内的膜以及质膜)调控细胞或细胞器从细胞外到细胞内的转运,反之亦然。膜形成多种用于内源反应(例如多种酶控反应,其对于化合物的生物合成、新陈代谢或者分解代谢是重要的)的基质。膜对于识别和调控来自外界的信号也很重要,并因而有助于生物体的适当反应。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/变应原的相互作用、宿主细胞与信号分子如胰岛素、趋化因子、细胞因子以及激素的相互作用、以及宿主细胞彼此之间的相互作用,例如神经细胞之间的相互作用,特别是在中枢神经系统(脑和脊髓内)中的神经细胞之间的相互作用。
在本领域中许多文献揭示了活细胞与胞外信号相互作用方式的特殊方面。可能出现在受体与胞外的配体分子连接后的膜中的靶蛋白的磷酸化,对信号传导的类型和强度(magnitude)显得很重要。同样重要的是信号分子复合物和特异性胞内或者膜结合蛋白质的组装。这些蛋白质,例如调控蛋白或者骨架蛋白,可包括一个或者多个特异性的结构域,如SH2、SH3、PTB以及PTZ和WW结构域类型(见G.Cesarini et al.(eds):Modular Protein Domains.WileyVCH Verlag,2004)。细胞对于外界信号的反应也取决于膜的特性。特别是一些磷脂酰肌醇(PI)-相关化合物的存在,表现为对于具有普列克底物蛋白(pleckstrin)同源(PH)结构域的蛋白质,例如蛋白激酶C(PKC)实现功能具有重要性。
活细胞对于细胞外信号起反应的方式可以广泛变化并且包括磷脂代谢的特异性激活、特异性细胞黏附行为、GTP酶活性的改变、蛋白激酶如PKC的活性的定位、例如特异性转录因子的表达、胰岛素受体的敏感性以及受体和离子通道的空间排布和活性的调控。
神经细胞(神经元)之间的相互作用需要离子通道,包括Na+,K+和Ca2+通道的激活。另外,受体数目的调控,也与受体的不同类型相关,其对于正确的认知、情感和感觉运动(例如,听觉、嗅觉、感觉和味觉)的功能是重要的。这样的调控还通过神经调节蛋白(Nrg-1)和突触后密度蛋白(PSD-95)来介导,神经调节蛋白(Nrg-1)和突触后密度蛋白(PSD-95)的功能表现为依赖于膜的组成。最后,信号传导将导致多种特异性基因的激活,其共同调控意识、行为以及认知和智力能力。
细胞膜包括多种类型的化学成分,如磷脂、胆固醇、糖脂、鞘脂、硫苷脂、脑苷脂、神经节苷脂、蛋白质(包括糖蛋白、肽)、离子、维生素,以及除了水之外的多种其它成分。通常这些成分在膜上不是均匀分布的。可以区别为极性和非极性区域。尤其是对于所谓的“筏”,通常为质膜中小的非极性区域,已赋予特异性功能(Brown,D.A.,London,E.,(2000)J.Biol.Chem.275:17221-17224)。
由于物理和/或酶促过程,膜组成可以随着时间经受多种变化。膜类结构也形成了高尔基体和内质网(ER)的大部分并且它们的结构决定了它们潜在的功能和特性。
已经披露了几种影响神经细胞之间的相互作用并且提高认知功能的方法。
US 2005/0009779公开了一种以这种方式提高膜流动性并且改善受体功能的方法。其宣称饱和脂肪酸和胆固醇使膜硬化并且长链多不饱和脂肪酸和某些提高蛋氨酸代谢的成分结合可以使细胞膜以一种更好的方式发挥作用。该文件,例如例如,没有提到除了磷脂之外的极性膜组分的存在的重要性及食物组分如锰、钼、牛磺酸、半胱氨酸、硫酸盐、水的作用以及在合适的营养产品中用于改善膜功能的碳水化合物成分的特性。
US 2005/0203053公开了可以通过提高大脑中磷脂的生物合成来改善神经功能。这通过食用尿苷源,胆碱源和可选的脂肪酸来达到。其宣称突触传递被改善;神经突的数目和P2Y受体的敏感性被提高。美国专利2005/0176676公开了这些食物组分的相似作用。
WO 2004/028529公开了一种包括花生四烯酸的特殊磷脂,可选地与中链甘油三酸酯或者二十二碳六烯酸源结合,用于提高认知功能。
WO 2005/051091公开了一种甘油磷脂与鞘磷脂和/或胆固醇结合的特定混合物,该混合物类似于人类母乳的混合物并且以脂肪球存在于婴儿制品的生产中。声称该混合物有益于胎儿、婴儿和幼儿的认知和视觉功能的发展。
已提出将特定脂质混合物用于治疗疾病或者修正机体的功能中。
在EP 1279400中公开了一种等张脂质乳剂,其包括60-95wt%MCT和5-40wt%鱼油并且其不包括植物油。宣称这种脂质混合物快速修正器官和组织的细胞膜,并且在多种疾病的治疗中是有益的。
EP 0311091公开了一种胃肠外使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。宣称这样的脂质混合物对于遭受了外科手术、多发性创伤、烧伤、感染、肺功能衰竭和慢性炎症性疾病的患者是有益的。所公开的产品不包括完整的蛋白质或肽并且不适于完全营养。
EP 0484266公开了包括DHA和EPA、每升产品约24mg至约82mg的磷脂、以及核苷酸混合物的营养产品,其宣称对于滋养婴儿以及肝硬化和腹泻的饮食管理是有益的。
EP 1426053公开了磷脂、(神经)鞘磷脂或半乳糖脂在药物组合物的制备中的应用,所述组合物在胃肠外使用,用于抑制肿瘤细胞粘附、抑制转移细胞的粘附和/或抑制肿瘤转移灶的生长。提出的配方不适合于通过肠道的完全营养。但未指出其他食物成分可能以何种方式干扰所称的效能。
许多文献探索了二十碳五烯酸(EPA)或者二十二碳六烯酸(DHA)用于治疗炎症性疾病的有效性。但是,在证明给药这些ω-3脂肪酸的疗效中却出现了严重的困难。直到提交日期,主要在关节炎的治疗中,观察到了统计学上的显著性改善。
本发明的一个目的是以一种便利的方式,特别是通过给药一种美味的肠内配方,来改变多种类型细胞中的细胞膜(特别是筏)的组成。
发明内容
一方面,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)中的至少一种以及核苷酸成分,用作治疗或预防糖尿病、肥胖症和/或胰岛素抵抗的保健或药物组合物。
本发明现在提供了一种保健或者药物组合物,其包括:
a)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)中的至少一种的脂质成分;
b)包括来源于非人类来源的蛋白类物质的蛋白质成分,其至少提供半胱氨酸和/或牛磺酸;
c)包括锰和钼中的至少一种的矿物质成分。
所述的组合物优选每100g包括约50kcal至约120kcal。
在第一个实施例中,所述的组合物还包括核苷酸成分,选自由核酸碱基,如尿苷、胞苷、腺嘌呤、鸟嘌呤(胍)、胸苷,它们的磷酸化形式,特别是单磷酸化形式,例如一磷酸尿苷,还有腺苷和鸟苷,核苷酸和核苷组成的组。
可替代地,所述的组合物还包括可消化的碳水化合物成分,优选地包括半乳糖和/或核糖源。
优选地,脂质成分来自乳品来源(dairy origin),来自蛋类或者来自植物种子或者豆类的胚乳,并且其优选包括大小为0.001-10μm的脂肪球。
在详细说明和实施例中示出了所述组合物的具体实施方式。
还提供了根据本发明的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、骨髓细胞和红细胞组成的组中)的功能、改善哺乳动物的记忆功能、刺激哺乳动物的免疫功能、预防哺乳动物的肥胖症、自身免疫疾病等等的应用。
所述组合物用于制造某些药剂也是本发明的一部分,所述药剂用于治疗痴呆,如阿尔茨海默(氏)病、神经病变、免疫功能低下、变态反应、贫血症、肥胖症、糖尿病、自身免疫性疾病、心律不齐、心脏衰竭、肿瘤、COPD、支气管炎、关节炎、肝炎、慢性炎症、血脂异常和类风湿病。
附图说明
图1证实了当将根据本发明的产品供给大鼠(被注射了Aβ)时,乙酰胆碱的生物合成和转运的显著改善。
具体实施方式
现在已经发现特定食物组合物(也称为保健组合物)或者药物组合物可以改善活细胞的功能。
根据本发明的产品包括脂质成分(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)中的一种或者多种),并且还包括蛋白质成分,后者提供半胱氨酸和/或牛磺酸等价物,并可选地包括矿物质部分(其包括锰和/或钼)。可选地,还可有益地包括可消化的碳水化合物成分和/或核苷酸源(nucleotide source)
优选脂质成分提供的能量比制品中可消化组分所提供的能量多30%,所采用的计算因子(calculation factor)为9kcal每克脂质、4kcal每克蛋白或克可消化性碳水化合物、产品中的其他组分为0kcal。优选地,该产品包括总能量的32-80%的脂质含量,更优选33-60%,并且还更加优选36-50%。
脂质成分的量可通过应用本领域中已知可适用于测量食物基质中脂肪含量的方法而测定。例如,一般食物中的脂肪含量通过使用标准983.23来确定,而Roese-Gottlieb法(932.06)更适合于基于奶粉的产品(Lehner,R.,Estoppey,A.,(1954)Mitt.Lebensmitteluntersuchung Hyg.54:183-185),并且其它方法也可以用于测量在婴儿制品和临床营养中的脂质含量。
单一成分的含量可通过使用特定设计的用于测量特定成分的方法或者如983.23方法中提供的分馏从氯仿-甲醇部分的抽提物中分离的脂肪成分来确定。当两种公认的方法在统计学上显著不同时(使用P=0.05),采用给出最高值的方法。脂质成分可包括甘油三酯、甘油二酯、甘油一酯、磷脂、溶血卵磷脂、糖脂、固醇和其它脂溶性成分。为了本申请的目的,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、血糖苷脂和乳糖神经酰胺类。本领域中,用来测量食物基质中这些组分的量的具体分析方法已经为人所知。因此,应将这些量增加至如由其他测定总脂肪的方法所测得的量,只要它们不包括在那些测定值中。
组合物的极性部分表现为具有乳化特性,其会干扰通常用于生产均一液体制品的乳化系统,其还包括本发明的量的蛋白质、可消化碳水化合物和可选地矿物质成分。通过使用乳质成分作为糖脂和醣蛋白的源,适合于完全肠内营养的液体形式产品保持均一。
总脂质成分包括ω-3系列(ω-3)的长链多不饱和脂肪酸(链长度至少为18(个碳原子)并且缩写为LCP),特别是DHA、EPA和DPA中的一种或者多种。这些脂肪酸可以以甘油三酯、磷脂、鞘脂、糖脂或者其他食品级别形式存在。ω-3 LCP的量必须高于成人每次服用400mg,每天提供400-3300mg剂量的这些脂肪酸。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%,更加优选20-40%。液体产品中的EPA、DHA和DPA的总和的浓度为最少0.2mg/ml至最多15mg/ml,优选0.3-12mg/ml,更加优选0.4-11mg/mL。对于婴儿,ω3 LCP的量通常应该大于每次30mg,从而每天提供30-1000mg剂量的这些脂肪酸。
在一个具体实施方式中,本发明的一种组合物每100g包括:
a)1000至2000mg的DHA+DPA+EPA+糖脂;
b)30-80mg半胱氨酸+牛磺酸
c)0.3-2mg锰+钼
相比脂质成分中其他组分的量,脂质成分包括相对较低量的ω-6系列的长链多不饱和脂肪酸。ω-3/ω-6的比率将在0.3-5,优选0.4-4,更加优选0.5-2的范围内。ω-6 LPC的量将少于制品中脂肪酸的50wt%,优选5-40wt%,更加优选8-30wt%,最优选8-20wt%,尤其优选8-15wt%。
优选地,还包括饱和脂肪酸。这些包括那些链长度为8至24个碳原子的脂肪酸。优选这些脂肪酸包括那些链长度为10、12、14和16个碳原子的脂肪酸。饱和脂肪酸的量,如果存在,通常应为6-60%,优选10-40%,更加优选12-36%重量份的脂质相。尤其是,C14:0+C16:0的量通常应该占脂质相的6-60wt%,优选10-40wt%,更优选12-36wt%。中链甘油三酯可以来源于所谓的MCT油,或者来源于椰子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%。肉豆蔻酸和软脂酸(棕榈酸)可以作为酸、其盐、以及与烷基或酰基形成的酯(如在甘油酯中)或以其他恰当形式而包括在内。优选它们以甘油三酯包括在内,例如棕榈仁油或结构化甘油三酯(具有一个额外的ω-3 LCP)中存在的,或者以甘油二酯或甘油一酯的形式而包括在内。优选包括饱和脂肪酸的甘油一酯或甘油二酯,因为当包括较高量的脂质时,与甘油三酯形式相比,它们表现为可提供技术优势。
油酸(C18:1)优选存在于脂质相中。它应以脂肪酸的5-40wt%,优选6-35wt%,更加优选8-34wt%的含量存在。液体制品中的含量将处于0.1-2g/100ml液体产品,优选0.15-1.2g/100ml液体产品,更优选0.2-1.0g/100ml液体产品的范围。
可选地脂质成分的重要部分将包括复脂(complex lipid),如糖脂、如鞘脂如鞘氨醇(例如,鞘磷脂)、酸性神经鞘糖脂(acidsphingoglycolipids)、如硫苷脂和神经节苷脂,以及红细胞糖苷脂。在总的脂质成分中,除了甘油三酯和磷脂以外的物质的量优选为超过0.01wt%,优选0.015-1wt%,更加优选0.02-0.5wt%。为了最好的结果,鞘磷脂的量应该超过130微摩尔,优选135-3000,更加优选140-2000微摩尔,并且酸性神经鞘糖脂的量应该超过0.003wt%,优选0.005-0.5wt%,更加优选0.008-0.4wt%。神经节苷脂的量应该为超过7mg/L液体产品,优选8-80mg/L液体产品,更加优选9-40mg/L液体产品,尤其是9-25mg/L液体产品。优选的神经节苷脂为GD3和GM3。
这些化合物可在能够从微生物如酵母、细菌中分离出来的成分中找到,或在真菌、藻类植物和动物材料如蛋类、神经组织、成纤维细胞和乳类中找到。优选食用食品级别的成分。尤其是优选使用来自乳类的成分,如包括高水平的脂肪球的提取物。这些成分可从酪乳制造(manufacture of buttermilk)中获得,尤其是可在从酪乳(buttermilk)生产乳酪(cheese)后剩余的乳清(whey)中得到。可购得的合适产品包括“酪乳粉末”和“奶油乳清”。
乳清包括相对较高的量的小脂肪球,尤其当巨大蛋白质,如β-乳球蛋白已经被去除。可通过对脱脂产品施加过滤技术而增加小脂肪球的浓度,该技术浓缩在膜一侧上的脂质层并去除诸如盐和乳糖的分子。该产品称为“乳清微滤渗余物”。富集了酸性神经鞘糖脂的部分也可以采用所属领域已知的层析法,如离子交换来进行分离。
许多哺乳动物的乳汁适合于分离活性成分,然而,母马、绵羊、山羊和骆驼的乳汁尤其适合。最优选使用分离自绵羊乳汁的脂质提取物。
来自绵羊乳汁的脂质的量应该为超过脂质成分的5wt%,优选8-60wt%,更加优选10-40wt%。
例如来自于蛋、大豆、初乳、骨髓、脑、乳类尤其是富含脂肪球的酪乳部分,并且尤其这些脂肪球的膜是人们特别感兴趣的,包括入根据本发明的产品中。这些成分被浓缩在复合糖脂中,其还含有除了葡萄糖和果糖之外的相对高浓度的碳水化合物。这样的成分可以通过所属领域已知的方法来脱脂原始成分,例如,通过己烷提取或者离心,来进行分离。应该对于残留的脂质或者水性成分应用其他方法,从而分离更多的以脂肪球膜存在的极性脂质成分。合适的方法包括选择性去除分子量低于300的化合物,如矿物质和乳糖的,或者例如通过使用过滤法、吸附法、层析法、渗透技术或者沉淀法去除选择的蛋白质例如。
特别是尺寸较小的脂肪球,特别是那些直径小于4.0μm,优选小于3.0μm,更加优选0.001-2.0μm,最优选0.01-1.8μm的脂肪球包括感兴趣的组分。在其中例如由于脂肪酸分布不恰当而乳脂不合乎患者的需要的那些情况下,例如优选去除至少部分的较大尺寸的脂肪球,特别是直径大于4.0微米的脂肪球。
因此来源于乳类的脂质成分应该优选包括超过1wt%,更加优选1.2-20wt%,并且最优选1.3-16wt%的磷脂。另外,脂质成分应该优选包括0.1-20wt%,更加优选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%,更加优选0.3-9wt%,最优选0.35-8wt%的胆固醇或者胆固醇酯。优选从乳类中分离的脂质成分包括提高量的磷脂、糖蛋白、糖脂和胆固醇中的至少两种,并且更加优选所有成分的量高于在乳脂中的量。
终产品中的脂质组成优选包括乳成分(富含不同于甘油三酯的组分,并且相比于天然材料的脂质成分中的含量,尤其包括50%更多的来自乳类的较小脂肪球膜的糖脂和/或糖蛋白)的1-80wt%,更优选2-50wt%,最优选3-40wt%。
用于从乳制品中分离富集脂肪球成分的合适方法可以在美国专利6,824,809中找到,其结合于此作为参考。美国专利6,391,362也公开了从乳类或者乳脂的脂质成分中分离脂肪球成分的合适方法。然而,优选从其中分离尺寸较小的脂肪球,例如,通过对第二水相施加微滤。优选不磷酸化脂肪球的原始成分。
另外一个优选的从乳类中分离合适的较小的脂肪球的方法是对生产黄油、松软干酪或者酸奶酪后产生的水相进行微滤。尤其是绵羊、山羊和骆驼的乳汁是用于分离根据本发明的脂肪球成分的合适来源,即使它们的脂肪球的组成在很大程度上与人乳的脂肪球的组成不同。根据所述方法分离的脂肪球成分表现为没有潜在干扰物质,如朊病毒、病原体或者病毒。
尽管来源于这些成分的脂肪球或其部分是高度有效的,但是它们在根据本发明的终产品的制备期和保质期内没有必要保持完整。在加工过程中均质化步骤的应用,并且导致终产品有效性的成分(如蛋白质成分或者其它脂质成分)的包括在内,与成分中存在的原始脂肪球相互作用。因此,通常产品中脂肪球的尺寸会增大,并且超过50%的脂质成分将作为大于2微米的脂肪球并以非脂质体形式而提供。体积大于90%的脂质会以直径大于0.025μm的球状存在。
终产品的脂质成分优选每100ml液体产品包括大于0.56克,更加优选0.57-3.1克,最优选0.57-2.8克,尤其是0.57-1.4克的长链多不饱和脂肪酸。
在那些半固体和固体产品中的浓度没有被清楚提到或者不能直接从宣称的每日份的日剂量中得到的情形下,它们可以由宣称的液体产品中的活性成分的浓度,通过校正为干物质百分比,而最终计算出来,假定每100ml液体产品的干物质量为15g,每100g半固体产品的干物质量为35g,每100g固体产品的干物质量为90g。
在营养失调的人中,每日剂量中包括0.1-10g,优选0.2-5g的胆固醇源是有益的。合适的胆固醇来源包括胆固醇、它们的盐类和酯类。这样的营养失调的患者可以是医院的病人,遭受蛋白质-能量营养失调的患者以及老年人。不包括在这个组中的是那些长期采用不良进食方式的营养不良人群,其意指尤其是食用相对大量的反式脂肪酸和多不饱和脂肪酸,尤其是已经被氧化的植物油达数月。
矿物质成分包括至少锰或者钼,可选地可以添加镁和锌。优选锰和钼都被包括并且更加优选镁以有效的量而被包括。
在饮食中包括镁,对于改善细胞的膜功能,尤其是神经细胞的膜功能,看来是重要的。特别是那些营养不良或者具有遗传或者新陈代谢失调的个体已赋予产生鞘磷脂和/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,在这些失调或者快速生长的过程中,个体对这些化合物的生物合成的需求增高。这样的个体的实例是遭受神经疾病,如阿耳茨海默(氏)病、帕金森、抑郁症、ME的患者、那些遭受系统性红斑狼疮(SLE)、由于神经损伤或者脊髓损伤造成的瘫痪的个体、以及处于神经组织生长过程中的婴儿和胎儿,以及孕妇。
对于一个体重80kg的人,锰的每日给药/食用量应该超过7mg,优选9-300mg。液体产品中的浓度可以,例如通过采用每日体积并且通过计算每日剂量和每日体积的比率来计算。假设例如每管饲体积2000ml提供的锰浓度为至少7/2000ml=350mg/100ml。例如我们还假设每ml管饲的热量密度为1.0kcal或4.2kJ。这样每100卡路里的浓度最少为0.35mg/100kcal,优选0.45-15mg/100kcal或者>0.83mg/100kJ。
对于体重3kg、能食入400ml的婴儿,这个最小浓度为0.065mg/100ml。因此,对于能量密度为0.67kcal/ml的婴儿制品,浓度将超过大约0.1mg/100kcal。
已发现如上所述将锰包括在内,对肠道中乳酸杆菌的生长具有促进作用,与该作用相关的几个好处可在该有益作用之后发生,包括肠道pH值的降低,肠道中病原体生长的减少以及免疫功能强度和/或能力的提高(根据感染率下降和/或腹泻减少而测得)。而且可观察到粪便稠度改善,特别是便秘的发生频率改善。尽管这些肠道细菌的增加使利用锰增加,但仍可观察到对细胞功能的系统效应,尤其是当给与所给定的浓度时。
为了使辅因子恰当发挥作用,需要额外的钼,其对于产生膜的恰当组成(例如,它们的硫苷脂含量)表现出是重要的,尤其是保证神经细胞的适当功能。另外,将适当量的钼包括在内延缓老年人在衰老过程中的脑萎缩。在成熟和生长过程中或者在肠道炎症疾病和/或食物变态反应的过程中,也需要钼例如,以产生恰当的屏障功能(例如,肠的屏障功能)。
钼的适当量指的是多于2μg/kg体重/天的量,尤其是3-40μg/kgbw.d,优选3.6-32μg/kgbw.d。对于婴儿制品,这通常会产生2.0-40μg/100kcal(或者0.48-9.5μg/100kJ),优选2.6-30μg/100kcal(或者0.62-7.1μg/100kJ)的浓度,对于成人产品,将得到15-400μg/100kcal,优选18-100μg/100kcal,更加优选24-40μg/100kcal(分别相当于3.6-95μg/100kJ,优选4.3-23.8μg/100kJ,更加优选5.7-5.7μg/100kJ)的浓度。
对于一个体重80kg的个体,每日所用的镁的量应该为400-1000mg,优选480-800mg。当设计一个完全营养时,这产生的浓度为7.5-40mg/100kcal,优选9-30mg/100kcal,其相当于1.8-9.5mg/100kJ,优选2.1-7.1mg/100kJ。镁对于糖脂的充分的生物合成表现为是重要的。
为了实现几个目的(例如为了使铜的稳态正常化),可额外添加锌。例如为此,相对于铜,应该以8-40倍优选10-30倍的比值提供过量的锌。铜稳态的正常化对于增加含铜血浆铜蓝蛋白的饱和度以及防止膜成分包括APP或其部分的过度氧化均比较重要。
具有平衡的矿物质组分表现为是重要性的。这提高了每个患者的功效,也提高了在较大群患者中的适用性。这方面的平衡意味着如上文提及的所有矿物质均应该包括在内,同时如所指出的,相对量对于形成恰当的平衡也非常重要。
这些矿物质的合适来源包括具有有机或者无机阴离子的它们的盐类,如硫酸盐、碳酸盐、碳酸氢盐、氢氧化物、氯化物和柠檬酸盐。锰和钼的氧化物不应被使用,尤其不应在婴儿制品中使用。优选使用一些硫酸盐形式,其以这种方式,即硫酸盐提供了1-400mg/100g产品,优选2-250mg/100g产品,更加优选3-125mg/100g产品使用。钼适合以钼酸盐包括在内。
当产品内包括大量钙或者在总日常饮食中使用大剂量钙(例如,除了根据本发明所述产品,还食入大量营养补剂)时,锰和钼的作用可被拮抗。因此产品中钙量/镁量应为1-235:1,优选5-205:1,更优选10-100:1。
产品中包括的蛋白质成分必须有超过80wt%,优选90-100wt%为可消化的。蛋白质成分包括完整的蛋白质、可通过水解完整的蛋白质以及通过合成得到的肽,包括超过按重量计的80%的氨基酸的肽的衍生物,(天然产生的)氨基酸本身和牛磺酸,以及所述的氨基酸和牛磺酸的衍生物,如盐类、N-酰化或者N-乙酰化形式以及酯类。甜菜碱、二甲基甘氨酸、肌氨酸、核苷物质和胆碱也包括氮,但是不能作为蛋白质进行计算。
蛋白质是由于提供可用的半胱氨酸和/或牛磺酸等价物。食品生产中通常使用的所有蛋白质都提供半胱氨酸。如果将乳制品认为是蛋白质来源,应该认识到酪蛋白是一种相对较差的半胱氨酸源。因此至少部分地使用乳清蛋白质,尤其是α-乳白蛋白或者α-乳白蛋白中富含的乳清蛋白,从而提高产品中的半胱氨酸水平,是有益的。与在天然乳类中观察到的比值相比,β-乳球蛋白的量相对于α-乳白蛋白优选相对较低。
当乳类作为蛋白质源时,优选使用富含于蛋白或肽(其糖基化程度较高,如酪蛋白糖巨肽(CGMP))中的蛋白质成分。这些蛋白质/肽被限定为那些其中超过10%的氨基酸残基已经被糖基化的肽。用于包括在蛋白质成分中的乳类成分中CGMP的量优选高于20wt%,更加优选高于35wt%,最优选高于40wt%。
优选蛋白包括的组氨酸浓度为2.5g/100g蛋白,优选3.0-6g/100g蛋白,更优选3.3-6g/100g蛋白。这意味着当采用乳清蛋白达到相当程度时,需要包括游离组氨酸。
牛磺酸的量应该高于0.1g/日剂量,优选0.2-4g/日剂量,更加优选0.4-3g/日剂量。通常这个剂量产生在液体产品中高于5mg/100g产品,优选7-100mg/100g产品,更加优选9-60mg/100g产品的浓度。牛磺酸盐类也是合适的成分。
除了上述脂质、矿物质和蛋白质成分,本发明的组合物优选包括其它部分,如碳水化合物成分和/或核苷酸成分。另外,优选还包括维生素成分和/或甲基供体成分。
碳水化合物成分包括可消化的碳水化合物成分,其优选地包括半乳糖源和/或核糖源。为了在具有低升糖指数的碳水化合物混合物中提供足够的能量,这些可用的和可消化的非葡萄糖糖类的量必须低于食用者可用的葡萄糖量的50wt%,优选10-40wt%。合适的半乳糖源或核糖源为双糖,如乳糖和食品级别质量的合成单糖。虽然来自核苷酸的核糖促进产品的生理效应,但由于产品中核苷酸剂量相对较低,所以文献中未将其计算为对总核酸糖含量有贡献。
可消化的碳水化合物成分有益地包括量为可消化碳水化合物成分的0.1-10wt%,优选0.2-6wt%的葡萄糖胺,如甘露糖胺和半乳糖胺或者它们的N-酰化形式,例如N-乙酰化形式。
部分碳水化合物,特别是2-50wt%可以有益地为申请EP5103247.2.中已经描述的糖醛酸。部分低聚糖(在WO2005/027663中已经披露)对于下面所提到的用途也是有效的,尤其当与所宣称的蛋白质和矿物质成分一起使用。
碳水化合物成分优选地也包括肌醇源(a source of inositol)。内消旋肌醇是优选的形式,虽然允许达50%源自磷酸化形式,如植酸等价物,如肌醇六磷酸。磷脂酰肌醇看来也是合适的选择。
每天给药一个体重80kg的人的肌醇等价物的量为0-1500mg,优选320-1200mg,更加优选380-1100mg,最优选420-1000mg。当计算体重4kg的婴儿的理想的每日剂量时,结果为21mg。
有益地包括在制品中的其它成分包括核苷酸源。核苷酸源是那些在使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成分。合适的成分包括核酸碱基,如尿苷、胞苷、腺嘌呤、鸟嘌呤(胍)、胸苷,它们的磷酸化形式,尤其是单磷酸化形式,如一磷酸尿苷,还有腺苷和鸟苷,核苷和核苷酸。
尽管通过给药单一核苷酸源特别是一磷酸尿苷(UMP)可观察到有益效果,但是对于所声称的组合物的组分,可通过利用核苷酸、核苷或核酸碱基的混合物获得大致相当的良好效果,同时没有人体不希望的副作用风险。这种混合物优选从酵母或动物组织提取。
当UMP作为来源时,对于一个体重80kg的人的每日剂量的量必须为0.08-3g,优选0.1-2g,更加优选0.15-0.9g。基于体重所需要的等价物的剂量可以通过采用核酸碱基的等摩尔量并且通过使用UMP的分子量(其为324道尔顿)校正为分子量,而从UMP的剂量计算得到。
尿苷的衍生物,如UDP,其容易从饮食中的UMP形成,对细胞中的糖蛋白和糖脂的转运以及它们在细胞质和质膜中的可利用性表现为是重要的。
如果存在维生素成分,其应该优选地包括食品级别形式的维生素B6,其能够升高活的机体内肝脏和/或脑中的磷酸吡哆醛的水平。这意味着对一个体重80kg的人,维生素B6的每日剂量被限制为不超过50mg/天,优选不超过25mg/天的维生素B6。对于一个这样的人,有效的剂量是2-50mg,优选2.4-40mg,更加优选的是8-25mg维生素B6。对于具有不同体重的个体的最佳剂量可以通过采用成比例部分来进行计算。例如对于一个重3kg的婴儿,最佳的剂量是37-1875μg。维生素B6的优选形式是吡哆胺、吡哆醛、3-酰化吡哆醛类似物或者它们的盐类,如在US 6586414、US 6548519和US6339085(均结合于此供参考)中所披露的。
维生素成分还可以包括生物素、叶酸和维生素B12。
生物素应以超过1.5μg/kgbw.d,优选4-50μg/kgbw.d,更加优选5-40μg/kgbw.d的量被包括。对于成人,通常这样导致的产品中生物素的浓度大于6μg/100kcal,优选7-60μg/100kcal,更优选8-40μg/100kcal,而对婴儿则>3,优选4-50μg/100kcal,更优选4.6-30μg/100kcal。生物素的适当来源在本领域中已经为人所知。
叶酸类包括叶酸、亚叶酸,甲基化、亚甲基化和甲酰化形式的叶酸,其盐或者酯,以及其与一个或者多个谷氨酸的衍生物,和所有的还原或者氧化的形式。计算叶酸的量,对一个体重80kg的成人,该量应该为至少300μg/日剂量,优选420-2000μg/日剂量,更加优选520-1500μg/日剂量。对于婴儿,推荐的每kg体重的叶酸剂量稍微高于成人的。其应该为>10μg叶酸/kgbw.d,优选30-140μg/kgbw.d,更加优选45-120μg/kgbw.d。
所述制品的一个优选实施例包括维生素B12。尤其是该维生素B12不是氰钴氨素,而是从羟基钴胺素或者甲基钴胺素或者WO02/087593中公开的硫醇钴胺素(thiolatocobalamines)或者US6187761中公开的提取物中选出的成员。
其它的维生素,如维生素A、D、E、K、C、B1、B2、B3和泛酸,和矿物质和微量元素,如Na、K、Ca、Fe、Cu、Se、I、F遵循对于营养需求的一般推荐,尤其是在婴儿制品中。
另外,甲基供体优选包括在根据本发明的产品中。甲基供体当在哺乳动物的体内吸收时,能够产生至少一个甲基。合适的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。为了有效的结果,优选选择甜菜碱或者二甲基甘氨酸。当蛋白质源包括超过20wt%的植物源的蛋白质(如来自谷类如小麦、燕麦、大米、玉米或者大豆,或者种子/块茎如豌豆、羽扇豆、土豆或者大豆的蛋白质)时,在产品中包括额外的甲基供体的优势变的尤其明显。这样的产品中的有效剂量为超过0.18mmol/kg体重/日剂量,优选0.19-2mmol/kg体重/日剂量,更加优选0.2-1.2mmol/kg体重/日剂量。为了标准化,当把人的体重设定到70kg,这将意味着胆碱(或者二甲基甘氨酸,因为具有大约相同的分子量)应该以大于1.3g/2L产品的浓度在液体组合物存在。成人食用者所用液体补充物(量为400ml/天)则将包括1.3g/400ml。
来自磷脂的胆碱对甲基供体的量的贡献没有计算。
如果与甲基供体的量相比产品中甲基受体的量保持较低,则用一种或者多种甲基供体的加强作用就特别有利。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,甲基供体的摩尔数过量3倍是有利的。
此外,那些产品中可以有利地包括他汀类药物,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。在该期间,所述化合物可增加本发明所述组合物的效力。但是长期包括该类化合物(如辛伐他汀、洛伐他丁、罗伐他汀、普伐他汀、氟伐他汀、阿伐他汀)的缺点是,它们可能抑制羟甲基戊二酰基CoA还原酶(当被以相对较低的量给药时)的作用。因此,如果产品结合他汀类被使用较长的时间,该产品应该包括抵消给药他汀类的缺点的量的泛醌、泛醇类、维生素K2(menaquinons)、辅酶Q10、长醇、长醇酯类、长醇醚类、具有超过8个类异戊二烯单元的合成聚类异戊二烯类,这样的类异戊二烯带有一个或者多个羧酸族,具有类维生素A的羟基、番茄红素和固醇类的组中的一种或者多种。优选包括长醇或者它的类似物,其中长醇类似物至少80%分子大体上是非极性的。最多15%,但优选少于10%的碳原子被允许被极性基团,如羟基、烷氧基尤其是甲氧基,羧基、巯基、取代巯基、氨基、取代氨基、烷基或者酰基部分所取代。
这些内含物要求保持产品作为如癌症患者的免疫功能改进剂的效力,特别是作为降低对转移灶形成的敏感性的产品。例如与他汀治疗相结合,产品如果没有权利要求1中的产品的蛋白质和矿物质成分,在包括上面所提到的成分的量为每日剂量至少20mg的长醇类似物、至少4mg的类维生素A、至少4mg泛醌、泛醇类、甲基萘醌类或维生素K2,和至少0.02mg固醇类的条件下,产品表现为也是有利的。适当的固醇特别是天然固醇,如在哺乳动物有机体中存在的。
效果
根据本发明的产品使神经细胞的膜功能正常化,尤其是当这些膜发生变形和/或组成不当时。虽然有人可能推测这些缺陷的原因,看起来一种或者多种膜结合酶的功能失调,例如,神经磷脂酶的上调(其降低鞘磷脂含量并且升高神经酰胺水平)对这种病理表现为是重要的。而且,暴露于大量的应激原(stressor)、遗传倾向(geneticdisposition)和/或慢性营养不良可能促进赋予的神经功能的更迅速形成。
年龄高于50岁的人,因为衰老和非最适营养状况,尤其易于患这种疾病。具有变形的膜的大量神经细胞的出现会导致,例如认知功能、感觉认知的损伤,和控制肌肉运动系统(肌肉)的能力不完全。具有变形膜的神经细胞会开始合成提高的量的Aβ(Abeta)蛋白质,其引起淀粉样沉淀、形成斑(plaque)和/或神经原纤维缠结。变形膜还将开始变成几种亲脂类化合物,如几种在这种基质如Aβ二聚物,尤其是Aβ42中可溶的肽的宿主,其可能导致凋亡信号的释放和神经细胞的死亡。
最终,这可能导致特别是在老年人的脑体积,尤其是白质的体积的萎缩。由这些作用所造成的综合症已知通常为痴呆和阿耳茨海默(氏)病,尽管已经描述了这些病症的特殊形式。
神经病变部分是在机体尤其是神经组织较长时间暴露于提高水平的还原性等价物中,特别是还原型烟酰胺腺嘌呤二核苷酸(NADH)的情况下造成的。这样的水平,例如在遭受胰岛素抵抗,如糖尿病的个体中,在遭受局部缺血的个体中(例如在外科手术之后或者在受到将血流带到组织的其他物理创伤之后)或者酗酒的个体中升高。
人们可以区别出现在中枢(脑和脊髓)的神经病变和周围神经病变。根据本发明的组合物在这两种类型中都有效。中枢胰岛素抵抗可能导致如阿兹海默症或者帕金森症的病症。周围神经病变可能赋予(impart)运动和感觉功能和/或导致下面所解释的疼痛。这样的神经病变也可以包括特异性器官,如肝脏中的神经功能。不希望被理论所束缚,本发明的组合物降低胞质唾液酸酶的活性,并且升高神经细胞的必要组分,包括硫苷脂类和神经节苷脂类的生物合成率,可能是重要的。
由于抗体袭击造成的神经病变表现为也有所降低。不希望被理论所束缚,在这种类型的患者中,施万型细胞的功能的改善(尤其是在修复受损的髓磷脂和细胞碎片方面)促进了这个作用,正如血-神经屏障的改善和骨髓中的神经胶质细胞的活性状态的降低一样,这看来是重要的。这使本发明的组合物在治疗多发性硬化症和降低慢性或者神经性疼痛(与普通疼痛相对)中十分有用。
给药根据本发明的组合物,表现为可改善神经细胞之间的相互作用,该效应对于机体对外界诱因的许多反应具有重要影响。例如,感觉诱因的适当注意和处理以及作为对这些诱因的反应的运动功能的充分确定得到改善。相互作用对于思维过程和情感意识,包括感到害怕和疼痛(包括阈值功能)是必要的。
另外许多器官和/或细胞恰当发挥功能(至少部分地受迷走神经控制或者对例如通过上皮细胞和巨噬细胞释放的局部的乙酰胆碱起作用),依赖于神经细胞恰当处理这些信号的能力。这样的反应的实例包括在感觉认知到食物成分后胃肠道活性,以及在静息中(心律不齐)和在锻炼过程中的心脏的活性。另外一个实例是免疫系统,尤其是在血液、淋巴、尤其是肺和胃肠道的上皮细胞中循环的免疫细胞的活性。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、潘氏(帕内特,Paneth)细胞和派氏淋巴结(Peyer patches)、和淋巴细胞(如在固有层中局部存在的淋巴细胞)的活性,其都受它们的膜组成和功能的强烈影响。
包括自主神经系统和下丘脑的中枢神经系统的功能的改善,包括脑白质的功能,并且产生更好的思考能力、提高的情感感受、交流技能和记忆功能。
本发明人声称除了神经递质释放和受体功能(特别是G蛋白受体),神经细胞的膜组成也改善了,尤其是与膜的总的质量相比和/或与非极性成分的量相比的它们的极性脂类成分,如硫苷脂类、神经酰胺、鞘脂、糖蛋白和糖脂,的含量。非极性成分的实例为胆固醇和二聚体肽,尤其是较大的膜蛋白质,如淀粉样前体蛋白的同源二聚体非极性肽的量,更尤其是Aβ-42片段的二聚体形式。以这种方式其目标是改变膜筏的大小和组成,并且保持筏的活性部分的恰当功能。以这种方法,不仅受体的功能改变(其可能是由于受体的配体分子的亲和力的改变和区分能力的提高,或者配体的内在活性的改变,例如通过影响第二信使,如IP3途径);而且糖蛋白和膜结合酶的活性也改变。以这种方法,完成了活细胞的代谢和生理活性的显著改变。这尤其适用于神经细胞、免疫细胞、骨髓细胞、干细胞和血细胞,如红细胞的功能。本发明人发现通过给药根据本发明的组合物,乙酰胆碱的生物合成和转运得到改善。膜结合胆碱乙酰转移酶(ChAT)的功能,以及其越过囊膜进入突触间隙的转运得到改善。乙酰胆碱的释放是脑功能的必要部分,其包括认知功能和副交感神经系统,尤其是迷走神经的活性。这部分神经系统调控胃肠道行为以及例如心律。通过给药根据本发明的组合物,达到对心脏心律不齐、肠道运动和肠道介导的系统免疫反应的改善。
根据本发明的组合物在修复受损神经组织中也是有益的。神经损伤可以发生在创伤,例如外科手术或者脊髓伤害后,也可发生在慢性暴露于高心脏舒张血压之后的脑中。
根据本发明的组合物在多发性硬化症的治疗中也是有益的。脱髓鞘的过程,以及脑中脱髓鞘斑的产生,被减缓。
在遭受帕金森症的患者中,尤其是先天的帕金森症(PD),根据本发明的组合物降低黑质细胞的衰退率。特别是在PD患者,以及在遭受特殊形式的痴呆,例如路易体痴呆(Lewy体痴呆),或者遭受多系统萎缩(MSA)和肌萎缩性脊髓侧索硬化(ALS)的患者中,淀粉样斑块的量以及脑中的α-核突触蛋白和路易体的量会降低。
脑中的过量蛋白质的这种沉淀,尤其是在神经元和神经胶质细胞中的沉淀,如亨廷顿氏(Huntington’s)病过程中出现的聚谷氨酸积聚,和多种形式的痴呆、瘫痪和皮质延髓变性中的tau-蛋白质,可以通过根据本发明的组合物的干预而容易地被抵消。细胞内膜,例如高尔基体的和/或内质网膜的膜的变化,以及随之发生的蛋白质的不同改变在产生这种效果中可能也发挥作用。
当用于给药遭受胰岛素抵抗的患者、以及给药婴儿或幼儿时,重要的是包括升高胰岛素敏感性的组分,例如包括所有必要氨基酸并且具有相对较高的天冬氨酸/谷氨酸比率,尤其是高于0.42,优选0.44-0.8,更加优选0.45-0.6的蛋白质成分或者至少包括核黄素等价物、维生素B6和/或生物素或者优选三种维生素都有的维生素成分。这样的蛋白质成分的实例包括α-乳白蛋白或者添加了天冬氨酸的蛋白质混合物。
在对遭受糖尿病的患者给药组合物的情况下,更有益的是将该组合物作为甲福明二甲双胍的佐剂给药以避免与已知可降低胰岛素敏感性的药品同时给药。对于遭受胰岛素抵抗的患者,更优选在组合物中包括纤维或者纤维样物质,其包括抗性淀粉占纤维混合物超过的20wt%以上。对于糖尿病或者肥胖患者,包括纤维样物质,如可缓慢消化的淀粉、半乳糖低聚糖、纤维素或者果糖低聚果糖/低聚果糖也是有利的。对于这些类,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成分还调控胎儿发育过程中眼和脑的成熟。因此根据本发明的组合物可用来给药孕妇,用于形成婴儿的良好视觉和脑功能,包括认知能力和智力能力。
神经细胞之间的通讯增强,在抗癫痫性惊厥、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,表现的比较重要。
为了抗击这些失调情况中的紧急情形,根据本发明的组合物应包括于生酮膳食中。尤其是根据本发明的营养品的热量值必须高于产品中的蛋白质、脂质和可消化碳水化合物成分的热量值的40%。优选这个含量高于46%,更加优选高于50%。在这样的生酮产品中,脂质成分必须达到上面提到的标准。ω-6长链聚不饱和脂肪酸的量应该相对较低,而饱和脂肪酸的量应相对较高。
根据本发明的组合物中存在的活性成分,对于肠道的适当成熟和其屏障、免疫及转运功能的适当发育,也表现的是必要的。在已患这种消化道疾病的个体中,该效应变得明显,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降低。
不希望被理论所束缚,认为重要的是,根据本发明的产品改善上皮细胞、受体如CD1d受体,的膜功能,以及它们提高树突状细胞的恰当作用。这种恰当作用包括趋化因子和细胞因子的释放,其补充正确类型的淋巴细胞,提供恰当的“Th1/Th2”反应并且引导这些细胞正确迁移到淋巴结。这些作用降低病原体移动和病原体识别的速率。认为,补充正确类型的T细胞帮助抗击不需要的细胞,如变应原、病原体和变异细胞并且确定恰当反应,例如对于机体的变态反应。由于例如内皮细胞的质膜的组成改变,病原体和/或变应原,尤其是包括疏水部分的变应原,粘附更少和/或差异地粘附,这引起更为恰当的反应。另外,由上皮细胞产生的粘液素成分会提高,尤其是在硫酸化和唾液酸化成分的量会提高。
为了达到肠道条件的最大改善,尤其是在营养不良的患者中,根据本发明的组合物应该包括胆固醇源。尤其是,其量必须在2-100mg/100g,优选6-60mg/100g,最优选9-40mg/100g的范围内。合适的来源为游离的胆固醇或者胆固醇酯(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。这表现在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促进肺的发育和肺组织的恰当修复,例如,在烧伤、暴露于毒物、肺气肿和慢性身体暴露如慢性咳嗽后和在发炎过程中和相关的肺部感染和作为如COPD和支气管炎的慢性阻塞性肺疾病的结果。
肺组织包括大量的特异性表面活性分子,其生物合成率通过根据发明的组合物而提高。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。肺部发育的问题可以通过在适当的时机,例如在妊娠6个月之后分析羊水的成分,尤其是鞘磷脂相对于其它脂质成分的量进行辨别。
当提供给患者用于提高肺部功能时,脂质成分应该包括相对较高量的棕榈酸(C16:0),尤其是超过总脂质成分的脂肪酸的10wt%,更尤其是10.5-18wt%。棕榈酸应该优选在甘油三酯成分中具有超过15%的sn2位置。
根据本发明的制品治疗COPD的功效,可以通过测量显示呼吸能力的参数,例如FEV1.0,和/或测量不同类型毒蕈碱受体的表达和唾液(sputum)细胞的趋化因子的分泌(如在Profita M.,et al.(Allergy,2005,60:1361-1369)中所披露的)而确定。
根据本发明的组合物改善了对身体中不需的细胞(如变异细胞或者肿瘤细胞)的识别,并且改变了通过抗原刺激的巨噬细胞产生细胞因子的模式。因此它们降低了形成肿瘤的风险并降低了在切除术或者通过其他方法如放疗或者化疗破坏后肿瘤复发率,且降低了转移灶形成率。
细胞膜的组成和构造表现为影响细胞中还原性等价物的转运,例如在对胰岛素敏感性的形成中。因此本发明的组合物降低了在儿童时期和成人时期形成肥胖的趋势。
在对抗肥胖中,本组合物表现为可降低循环性C-反应蛋白(CRP)的量并且降低由脂肪组织释放的CRP。通过脂肪组织的抵抗素的内源合成被升高。以这种方式,可降低代谢综合症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。
特异性器官和细胞器的内分泌功能,其包括胰腺、下丘脑和肝脏中的高尔基体和内质网的功能,并包括神经细胞内小囊泡的生物合成以及内分泌信使从神经细胞中释放,得到改善。声称根据本发明的组合物促进胰腺释放胰岛素,囊肿性纤维变性患者中消化酶的分泌,垂体对于到达身体的其他部分或者由身体的其他部分产生的信号的适当反应,以及免疫功能,尤其是库佛氏细胞(Kupffer cell)的清除功能和产生急性期蛋白的器官的生物合成作用。
为了上述多种目的,该组合物可以有益地与几种类型的药物结合使用。本产品与大平面分子,如他汀类的结合使用已经在上面讨论过了,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。通常这些患者中的相对较大部分具有相对大量的斑和缠结。
当目标为提高认知功能时,尤其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。本发明的组合物也可以有益地与磷酸二酯酶抑制剂结合使用,
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。更好的膜的生物合成支持了脑中淀粉样蛋白的量的快速降低,其从而防止了残余的过量淀粉样蛋白的有害作用。
通常本组合物表现出其自身的有效性至少需要几天。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周尤其是超过2周的给药方案而获得。给药方案可以包括加载期(loading phase),其中在第1周,给药2或3个日剂量。然后,为了最佳效果,必须应用本文献中已经公开的日剂量。
实施例1
引言
在阿耳茨海默(氏)病患者中,特点之一是β-淀粉样(Aβ)斑的存在。Aβ斑的形成造成乙酰胆碱(涉及学习和记忆过程的神经递质)产生能力的降低。乙酰胆碱水平的降低导致记忆的丧失[Isacson,2002#766]。给小鼠注射含有Aβ的溶液产生在学习和记忆中的相似问题[Nakamura,2001 #621]。这个模型被公认为检测有益化合物对Aβ诱导的记忆丧失的效果。这个实验说明了Aβ输注对乙酰胆碱产生细胞和乙酰胆碱的转运体的作用。另外,采用一种饮食组合物来防止这种作用。
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。在输注前五周,这些大鼠被喂饲两种食谱中的一种,A或B。表1中总结了这四个组。表2列出了两种食谱的食物组成。食谱A用作对照食谱。食谱B富含DHA、EPA和磷脂以提高膜的质量。另外,其富含UMP和胆碱以刺激膜的合成。其还富含B组维生素和叶酸以降低同型半胱氨酸的水平。
表1:输注溶液和食谱不同的大鼠分组
组2:食谱的组成
结果
表3(和图1)列出了Aβ输注和饮食干预对于乙酰胆碱的产生和转运能力的效果。对喂饲食谱A的大鼠进行Aβ输注导致乙酰胆碱产生细胞(ChAT)减少并导致乙酰胆碱(VAChT)转运能力降低。喂饲食谱B将乙酰胆碱的产生和转运能力恢复到正常水平。
表3:ChAT和VAChT的结果
讨论和结论
心室外侧输注Aβ可引起乙酰胆碱生成和乙酰胆碱转运能力下降。这些结果通过喂饲富集ω-3脂肪酸、磷脂、B组维生素和UMP/胆碱的食谱被完全消除。
实施例2
即用型(ready to use)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;可消化的碳水化合物4-20g,并且其包括
a- DHA+DPA+EPA=1000-2000mg
b- 30-280mg 半胱氨酸或者牛磺酸
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
h- 0.07-2mg 钼。
实施例3
用于阿尔茨海默(氏)病患者的即饮型(ready to drink)液体,每100ml包括
能量 100kcal
蛋白质 3.06g(酪蛋白,乳清80/20)
碳水化合物 13.3g(麦芽糖糊精、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、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水重制(reconstitution)后,可提供:
能量 64-80kcal
蛋白质成分 1.0-2.0g 专一基于游离氨基酸或者它们的盐,并且其包括至少2wt%的半胱氨酸和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(buttermilk fat)和0.5-8wt%蛋类脂质(包括卵磷脂)
核苷酸等价物 1-40mg UMP和酵母提取物的混合物
锰 65-1000μg 以盐的形式特别是MgSO4包括在内
钼 2.3-300μg 以盐的形式特别是钼酸盐包括在内
胆碱等价物 20-200mg 以胆碱盐、特别是酒石酸氢胆碱包括在内
在这个实施例中,包括附加成分,如Na、K、Cl、Ca、P、Fe、Cu、Zn、Se、Cr、I、维生素A、D、E、K、B1、B2、B3、B5、B6、B12、B11、生物素和C,它们的量的确定遵循对于婴儿制品的推荐。也包括肌醇。
实施例5
用于患免疫功能低下的患者的产品
即用型液体产品,每100ml包括
能量 630kJ(或者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、麦芽糊精、缓慢消化淀粉)
脂质 5.3g(1g乳脂、1g海洋动物油(marine oil)、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、半乳糖寡糖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、维生素A 0.12mg RE、维生素D 1.1μg、维生素E 1.6mgTE、维生素K 8μg、维生素B1 0.23mg、维生素B2 0.24mg、维生素B3 2.7mg NE、泛酸 1.0mg、维生素B6 0.8mg、维生素B11 80μg、维生素B12 0.4μg、生物素 10μg、维生素C 12mg。
实施例6
用于患癌症、HIV、进行骨髓移植、患心脏衰竭或者COPD的患者的产品。
即用型液体组合物,基于全脂巴氏灭菌绵羊或骆驼乳,每100ml包括:
0.4g海藻油、0.4g甜菜碱、0.4g核糖、和0.2组氨酸,并且还有Na 50mg、K 160mg、Cl 100、Ca 150mg、P 120mg、Mg52mg、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、维生素D 1.3μg、维生素E 2.3mg a-TE、维生素K 10μg、维生素B1 0.3mg、维生素B2 0.3mg、维生素B3 3.4mg NE、泛酸 2mg、维生素B6(如吡哆醛)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包括
能量 336kJ
蛋白质 4.0g(3.6g大豆蛋白分离物、0.2g天冬氨酸、0.2g组氨酸)
脂质 4.0g(长醇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、麦芽糊精6g、缓慢消化淀粉2g、蔗糖2g)
锰 1mg
钼 0.1mg
甜菜碱 100mg
纤维 1.0g(抗性淀粉、半乳糖寡糖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、维生素A 0.12mg RE、维生素D 1.1μg、维生素E 1.6mgTE、维生素K 8μg、维生素B 10.23mg、维生素B2 0.24mg、维生素B3 2.7mg NE、泛酸 1.0mg、维生素B6 0.8mg、维生素B1180μg、B12 0.4μg、生物素 10μg、维生素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包括
蛋白质 4.75g(豌豆蛋白、酪乳乳清)
脂质 3.78g(包括20%较小脂肪球的绵羊乳脂质成分0.4g,蛋类脂质1g,植物油1.98g和0.4g水产动物油(marine oil))
碳水化合物 11.75g
半乳糖 1.5
帕拉金糖(异麦芽酮糖)3.0
缓慢消化淀粉 1.0
果糖 0.2
麦芽糊精 3
葡萄糖 2
异麦芽低聚糖 1.05
纤维 2.0g
半乳糖寡糖 1.0
抗性淀粉 0.6
纤维素 0.1
果糖低聚果糖/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(麦芽糊精、蔗糖)
脂肪 7.3g(鱼油、来自绵羊乳汁的糖脂富集成分)包括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B 60.8mg
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 维生素 A、0.15mg 维生素 B1、0.16mg 维生素 B2、1.8mg维生素 B3、0.53mg 维生素 B5、0.7μg 维生素 D、4.0μg生物素以及5.3μg维生素 K,二甲基甘氨酸半乳糖。
Claims (16)
1.一种脂质成分和核苷酸成分在制备用于治疗或预防糖尿病、肥胖和/或胰岛素抵抗的保健或药物组合物中的应用,其中所述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)中的至少一种。
2.根据权利要求1所述的应用,其特征在于所述组合物还包括蛋白质成分和矿物质成分,其中所述蛋白质成分提供半胱氨酸和/或牛磺酸而所述矿物质成分包括锰和钼中的至少一种。
3.根据权利要求1或2所述的应用,其中所述核苷酸成分选自由核酸碱基如尿苷、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一磷酸尿苷;核苷酸;以及核苷,尤其是腺苷和鸟苷组成的组。
4.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括ω-6长链多不饱和脂肪酸(具有碳链长度为18或更长),其含量占所述脂肪酸的8-30wt%。
5.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括0.01wt%以上的选自糖脂、神经节苷酯、硫苷脂以及鞘磷脂的组中的至少一种组分。
6.根据权利要求1-5所述的应用,其中所述组合物还包括可消化碳水化合物成分,优选半乳糖源和/或核糖源。
7.根据权利要求1-6所述的应用,其中所述组合物包括脂质成分,所述脂质成分至少部分地来源于乳制品、来源于蛋类或者来源于植物种子或豆类的胚乳。
8.根据前述权利要求中的任一项所述的应用,其中所述脂质成分包括大小为0.001-10μm的脂肪球。
9.根据前述权利要求中的任一项所述的应用,其中所述脂质包括1.3-16wt%磷脂和/或0.1-20wt%糖蛋白和糖脂。
10.根据前述权利要求中的任一项所述的应用,其特征在于,所述组合物包括蛋白质成分,所述蛋白质成分中天冬氨酸与谷氨酸的重量比至少为0.42。
11.用于改善老年对象中的认知功能的组合物,具有能量含量50-120kcal,蛋白含量1-10g,脂质含量1-5g,以及可消化碳水化合物含量4-20g,其包括
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。
12.粉末状抗变应性婴儿制品,按每100ml水15.4g粉末重制后,包括64-80kcal的能量含量,以及:
1.0-2.0g蛋白质成分,其专门基于游离氨基酸或它们的盐,并且其包括至少2wt%半胱氨酸和0.2wt%牛磺酸;
2-4g脂质成分,其基于脂肪酸总和包括2wt%的DHA,其中所述脂质成分包括5-40wt%的酪乳脂肪和0.5-8wt%的包括卵磷脂的蛋类脂质;
1-40mg核苷酸成分,其包括UMP和酵母提取物的混合物;
76.3-1300μg矿物质成分,其包括65-1000μg的锰和2.3-300μg的钼,所述锰以盐特别是MnSO4的形式包括在内,所述钼以盐特别是钼酸盐的形式包括在内;以及
20-200mg胆碱,其以胆碱盐特别是酒石酸氢胆碱的形式包括在内。
13.根据权利要求1-9中所限定的组合物用于改善哺乳动物细胞功能的应用,其中所述哺乳动物细胞选自神经细胞、免疫细胞、干细胞、骨髓细胞和红细胞的组。
14.根据权利要求1-8和10中的任一项所限定的组合物用于刺激哺乳动物中的免疫功能的应用。
15.根据权利要求1-7中的任一项所限定的组合物用于预防哺乳动物肥胖的应用。
16.根据权利要求1-7中的任一项所限定的组合物用于制备一种药物的应用,所述药物用于治疗选自由神经病变、免疫功能低下、肥胖、糖尿病、自身免疫疾病、心律失常、心脏衰竭以及由糖尿病引起的慢性炎症和感染组成的组中的适应症。
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