CN1921842A - 包含泛酸或其衍生物的组合物及其刺激食欲的应用 - Google Patents
包含泛酸或其衍生物的组合物及其刺激食欲的应用 Download PDFInfo
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- CN1921842A CN1921842A CNA200480042052XA CN200480042052A CN1921842A CN 1921842 A CN1921842 A CN 1921842A CN A200480042052X A CNA200480042052X A CN A200480042052XA CN 200480042052 A CN200480042052 A CN 200480042052A CN 1921842 A CN1921842 A CN 1921842A
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Abstract
本发明涉及食品组合物及其应用的领域。具体而言,本发明提供包含至少15En%蛋白质和泛酸或其等价物的组合物,其适于刺激食欲。
Description
技术领域
本发明涉及食品组合物及其应用的领域。具体而言,本发明提供包含泛酸或其等价物的组合物,其适于刺激食欲。
发明背景
泛酸是水溶性维生素,也称为维生素B5,其是辅酶A(CoA)的组分。泛酸发现于多种食品中,如鱼、肉、蛋、乳制品和蔬菜,因此在人中很少观察到泛酸的天然缺乏。在以前所进行的研究中,通过给予泛酸缺乏饮食(如Fry等,1976,J.Nutr.Sci.Vitamology 22,339-346)和/或已知表现出抗泛酸样作用的诸如ω-甲基泛酸的化合物(参见如Hodges等,1959,J.Clin.Invest.38,1421-1425)而在人中试验性地诱导泛酸缺乏。此试验的参与者所表现出的症状为胃肠道不适(恶心、呕吐、腹部绞痛)、易怒、烦躁、疲劳、冷漠、倦怠、头痛、失眠、麻痹或手足刺痛、感觉异常(parasthesia)、肌肉痉挛、步态蹒跚、低血糖和对胰岛素敏感性增加(参见如Hodges等,1958,J.Clin.Invest.37,1642-1657;由Food Standards Agency,Aviation House,125Kingsway,London WC2B 6NH,UK出版的报告“Expert Group on Vitamins andMinerals 2003”)。在其它研究中,当人食用无泛酸饮食时,没有发生临床缺乏病征(Fry等,1976,J.Nutr.Sci.Vitminol.22(4),339-346)。推断出上述研究均没有揭示泛酸缺乏与食欲下降相关或者泛酸可用于恢复食欲下降。这些研究也没有揭示泛酸可用于恢复体重。特别提及的是从来没有将对泛酸的需求增加与严重疾病如癌症、艾滋病、呼吸疾病如肺气肿所致的分解代谢、严重创伤如外科手术和严重腹泻如炎性肠病发作联系起来。换言之,通常并不认为与一些严重疾病相关的食欲差和体重下降是由泛酸缺乏导致的。
Vaughan和Vaughan(J.Nutrition,(1960)70:77-80)描述了感冒对于泛酸缺乏大鼠的体重、食物摄取和乙酰化活性的影响。他们提供了一些数据,从这些数据可以导出,通过33天喂食用酪蛋白作为蛋白源并用植物油作为脂质源,但缺乏泛酸的人工饲料而引起泛酸缺乏状态的健康大鼠在体重增加和食物摄取增加方面因给予泛酸而获益。然而,作者的结论是,泛酸水平与食物摄取之间没有联系,并且泛酸对与食欲相关的生长没有影响。此外,没有与对味觉感知完全不同的人患者的潜在有益作用联系起来,尤其没有与患有末期癌症、艾滋病、慢性阻塞性肺病或其它严重疾病的人联系起来。
EP 0914111涉及用于预防和治疗恶病质和食欲缺乏的方法及营养组合物。该文件没有提示泛酸对食欲的有益作用,也没有指出饱和脂肪酸的量,特别是肉豆蔻酸有任何相关性。
DE 4304394涉及用于肠内给予肿瘤患者以克服与体重下降相关的问题的制剂。所述制剂的特征在于特定类型脂肪的平衡组合物。还公开了包含泛酸钙和泛酸的制剂,但是没有提及或提示泛酸水平与刺激食欲之间的关系。
诸如DE 29916231、JP 5294833和US 6322821的几个文件描述了包含泛酸钙的多种维生素组合物,其用于治疗人和牛的食欲下降等。然而这些文件均没有公开组合物中泛酸水平的关键作用。
Institute of Medicine的Food and Nutrition Board没有设定泛酸摄取的推荐饮食定量(recommended dietary allowance,RDA)(Eissenstat等,1986,Am.J.Clin.Nutr.44(6),931-937)。而是仅有关于不同年龄或目标组的大致合适的日常饮食摄取值(AI)的描述,其范围为从婴儿的1.7mg/日到成人的4-5mg/日和妊娠或哺乳期妇女的6-7mg/日(Department of Health,1991,In:Dietary reference values for food,energy and nutrients for the United Kingdom.HMSO,London,p113-115)。而且,没有设定泛酸的可耐受上限,因为似乎消费大量泛酸没有副作用。所描述的唯一报道的副作用是与每日摄取10-20mgD-泛酸钙相关的腹泻发生(Flodin 1988,Pharmacology ofmicronutrients;New York,Alan R.Liss,Inc.)。UK Council forResponsible Nutrition推荐泛酸长期和短期补充的安全上限为1000mg/日(Leaflet CRN 1999,The safe use of supplements benefit goodhealth)。
除了饮食泛酸摄取外,在结肠内建群的细菌也能够产生泛酸,因此产生于个体小肠内的泛酸被吸收并提供此维生素的另一来源是可能的(Said等,1998,Am.J.Physiol.275:C1365-1371)。然而,不知道是否内源产生的泛酸构成体内总泛酸水平的较多量。为了引起试验动物中的泛酸缺乏,在试验设计中,泛酸的内源产生常常使采用抗生素处理成为必要(Stein and Diamond 1989,J.Nutr.119(12),1973-1983)。
可商购的维生素增补剂大多也含有泛酸或其衍生物,如泛酸钙、泛酸钠或泛酰醇,它们比泛酸更稳定。通常使用D-异构体,但也可以使用DL-消旋混合物。与食物一起摄入的泛酸在小肠中被吸收并通过血(在红细胞中主要是结合形式)被转运到各种机体组织。大部分组织通过活性钠依赖性协同转运机制从血中输入泛酸。没有发现泛酸的血浆水平与饮食摄取水平十分相关,但是发现泛酸的泌尿排泄与饮食摄取有良好相关性(Eissenstat等,1986,American J.of ClinicalNutrition 44,931-937)。
已提出饮食泛酸补充在肥胖的治疗中具有有益作用。Leung(1995,Medical Hypotheses 44,403-405)描述了当对含低卡路里饮食(约1000卡/日)的摄取补充大每日剂量的泛酸(约10g/日)的联合给予时,实现了每周约1kg的体重逐渐下降,而节食者没有感觉饥饿或虚弱,并且酮体形成显著降低(在尿液中仅检测到微量)。特别地,提出在低卡路里摄取期间,泛酸在大剂量摄入时可被称为“饥饿抑制剂”。
然而该文件没有提出除补充低卡路里饮食以解决与节食相关的饥饿、虚弱和酮体形成以外泛酸的任何其它应用。而且,它清楚地教导了泛酸作为饥饿抑制剂的应用。与此相反,本发明的发明人发现,将包含泛酸或其等价物的组合物给予患有食欲下降,尤其是由于疾病或疾病治疗所致的食欲缺乏的个体,刺激食欲或饥饿并增加(特定组的)人的体重和肌肉质量。
与例如存在于几种植物油如椰子油中的月桂酸、棕榈酸和硬脂酸一样,肉豆蔻酸是饱和脂肪酸。因此,它可少量存在于人造临床营养剂中。认为饱和脂肪酸是可能导致心血管问题的不期望的脂质成分。饱和脂肪酸和椰子油难以用于制备液体制剂,因为它们可能导致过多的乳状液分层,因此在现有技术中避免包含它们。而包含玉米油、菜籽油、葵花油或大豆油,它们在最终制剂中形成均匀的乳状液并包含<0.5%的肉豆蔻酸。它们还包含大量亚油酸,其被认为是高度期望的。
本发明的详细描述
定义
“泛酸”或“泛酸盐”或“维生素B5”指酰胺连接于β-丙氨酸的泛酸基团(泛酰β-丙氨酸)。该定义限于泛酸盐的活性立体异构体,即泛酸盐的D-异构体。
“泛酸衍生物”或“泛酸等价物”在本文中用于指衍生自泛酸并具有与泛酸相同或改善的食欲刺激作用的化合物,例如但不限于:泛酸的盐(如泛酸钙、泛酸钠)、酯或醚;泛醇(或泛酰醇、本多生醇);(R)-pantoate或其盐、酯或醚;泛酰巯基乙胺(连接于β-巯基乙胺基团的泛酸)或其盐、酯或醚,如S-乙酰泛酰巯基乙胺;辅酶A(CoA),其由通过酸酐键连接于腺苷5’-一磷酸的4’-磷酸泛酰巯基乙胺组成,被3’-羟基磷酸修饰;包括例如乙酰CoA、琥珀酰CoA等。同样,特别地指活性D-异构体,例如D-泛酸钙。
“食欲的下降”或“食欲下降”指缺乏消费食物的欲望,特别是多于几天,如1-5天。
“肠内”在本文中指直接递送至个体的胃肠道内(如口服或经管、导管或气孔递送)。
“胃肠外”在本文中指递送至除胃肠道以外,特别是静脉内递送至血、皮下、肌内递送等。
“给予”在本文中指由他人或个体自身肠内或胃肠外递送至所述个体。因此,理解为也指例如通过所述个体进行的食物消费。
“食品”在文本中指包括液体,如饮料。
“食品组合物”在本文中指适于给予人个体的组合物,其每日剂量包含至少15En%(能量百分比)蛋白质(或水解蛋白质或氨基酸)和/或至少32En%糖类和/或至少18En%脂质,且提供至少100kcal/每日剂量。在一个实施方案中,所述组合物包含至少15En%蛋白质(或水解蛋白质或氨基酸)和至少25En%脂质和至少40En%糖类。为了更好地帮助人的完全营养,还可以包含一种或多种维生素、矿物质、微量元素和其它食物组分如膳食纤维、肌酸和/或肉碱。完全食品组合物应包含所有这些。
术语“包含”解释为指所述的部分、步骤或组分的存在,但是不排除一种或多种其它部分、步骤或组分的存在。
食欲下降是一种严重的症状,其经常导致不期望的体重下降并增加经常是由于疾病、病症或不适导致的或作为疾病处理或治疗的副作用或外科手术后的分解代谢过程。食欲下降在癌症患者、HIV感染患者或艾滋病患者、患有严重呼吸道疾病、分解代谢疾病的患者、患有严重腹泻(如与炎性肠病或节段性回肠炎相关的腹泻)或手术后创伤的患者、正在接受或已接受化疗或放疗的患者等中出现。
良好的营养对于帮助克服疾病或病症本身或其治疗效果和恢复体力是必要的。如果持续较长时间,食欲下降可能导致严重的体重下降和食欲缺乏,并会减慢或阻止患者的恢复,甚至可能导致患者死亡。在癌症治疗中,例如已很好地认识到营养在决定癌症患者生存中的重要性,因为当体重指标降到20以下时,有死亡率的指数增加。此外,食欲缺乏和继而的体重下降经常导致患者及亲属的心理忧虑。
目前,使用不同的方式来刺激食欲,这取决于相关的状况或治疗。除了特殊饮食和营养学家的护理(例如试图通过减小食物大小、增加饮食频率、变换口味等来激发患者的食欲)以外,经常给予食欲刺激组合物(即食欲刺激剂)。例如,促食欲剂(orexigenic agent)(如孕酮、皮质类固醇和cannabinoid)帮助刺激食欲并常用于治疗食欲缺乏/体重下降。
化疗患者相对频繁地接受屈大麻酚(一种合成cannabinoid),其有双重作用,因为它降低化疗诱导的恶心和呕吐,并且也刺激食欲。屈大麻酚以胶囊剂型口服给予,其以2.5mg、5mg或10mg胶囊的精确剂量制备,允许灵活的和个体化给药。屈大麻酚也用于其它情况来治疗体重下降和食欲缺乏。据报道,在仅4周的治疗后,屈大麻酚就在有伴有体重下降的食欲缺乏的免疫缺陷综合征患者中显著刺激食欲并引起增加体重、改善情绪和减少恶心的趋势。
尽管存在多种食欲刺激剂,但有对新的食欲刺激剂,优选无不期望副作用的刺激剂的一般需求。由于现有食欲刺激剂包含需要进行大量和花费大的政府批准程序的药物,因此提供基于公认无害、即使大量消费也无害的天然物质的食品或食品增补剂组合物将会是有益的。同样,目前使用的食欲刺激剂代替不了患者消费食品的需要,也不以一些方式接受营养品,因为所述食欲刺激剂不是食品组合物,而通常仅补充食品摄取。
在本发明的一个实施方案中,提供了一种(如上定义的)食品组合物,其包含泛酸或一种或多种其等价物。优选地,所述食品组合物每日剂量包含至少14mg泛酸或至少一种其等价物。优选所述食品组合物每日剂量还包含至少4wt%蛋白质(或水解蛋白质或氨基酸)和/或至少1.5wt%脂质。重量百分比是每100g组合物的组分的重量。
在本发明的另一个实施方案中,所述食品组合物是完全食品组合物,其指这样的组合物,其提供足以提供正常机体健康所需的每日卡路里摄取的量的蛋白质(或水解蛋白质或氨基酸)和/或脂质和/或糖类。这意味着当消费或被给予所述完全食品组合物(食品替代品)时,个体不需要(尽管他/她可以)消费或被给予任何其它食品。所述完全食品组合物每日剂量优选包含至少14mg泛酸或其等价物。由于期望是被治疗的个体体重不降低,而优选增加体重,因此优选所述完全食品组合物含高卡路里。优选地,其每日剂量包含至少600kcal,最优选至少900kcal或至少1200kcal或更多。
根据本发明的食品组合物和完全食品组合物包含足量泛酸或其至少一种等价物,当在足够的时间段内,优选几天例如至少两天至几周优选至少两周内被患有食欲下降(或有发生食欲下降的高危险)的个体摄入或被给予其时,其在人中刺激食欲(或防止食欲下降)(本文中称为“有效剂量”)。技术人员能够容易地使用已知方法确定是否本文描述的组合物具有期望的食欲刺激作用。例如,可随机地将患有食欲下降的患者分为两组。在几周内将包含泛酸或至少一种其等价物的组合物给予一组,而将缺乏泛酸(或其等价物)的等价组合物给予另一组。在几周内记录食欲,并比较两组。优选还记录体重。然后可以用标准统计方法确定是否所述组合物具有显著的食欲刺激作用。
本发明的另一个目的是,当在几周或几个月的时间段内以有效剂量给予时,所述食品组合物和所述完全食品组合物都导致个体的体重稳定,更优选导致个体的体重增加。这可以通过以固定间隔,至少一周一次,优选每天给个体称重而容易地确定。不要求体重增长的唯一原因是给予所述组合物。显然,由于食欲得到刺激,其可能是患者主动消费更多食品的效果。然而,完全食品组合物的给予优选自身提供足够的营养物及每日卡路里摄取,以稳定和/或增加体重。
所述食品组合物或完全食品组合物每日剂量优选包含至少14mg泛酸或其等价物。更优选地,所述组合物每日剂量包含至少15mg,甚至更优选至少18mg,或甚至更好为25-1000mg(如25、26、27、28,...,...,1000mg)。当使用泛酸等价物,尤其是泛醇、(R)-pantoate或其盐或酯或者泛酰巯基乙胺或其盐或酯时,所述组合物每日剂量优选包含至少14mg泛酸的等摩尔量。
所述食品或完全食品组合物的蛋白质组分可由完全蛋白质、水解蛋白质、部分水解蛋白质或氨基酸或它们的任意混合物组成。所述组合物的蛋白质组分每日剂量优选为至少4wt%、5wt%、10wt%或更高。在一个实施方案中,总蛋白的至少20%,更优选至少30%或50%或更高是乳清蛋白,优选酸性乳清。如所提到的,蛋白质组分可以是水解的,但使用完整蛋白质或仅部分水解的蛋白质(小肽)是优选的。
在另一实施方案中,所述组合物的蛋白质组分由植物蛋白组成,例如(部分的)水解植物蛋白,例如从蛋白贮存组织如块茎和种子中提取的蛋白质如来自马铃薯块茎的蛋白质、谷物蛋白如来自小麦、荞麦、大麦、黑麦、燕麦、玉米、稻、来自豆类(如大豆、菜豆、白豆等)的蛋白质、来自豌豆的蛋白质、来自种子如葵花籽、腰果、花生、含油种子油菜籽、羽扇豆籽等的蛋白质。原则上可以使用任何植物蛋白成分,其对人是安全的,并可以食物级获得。优选地,所用的蛋白成分也不引起人过敏。如果存在潜在的引起过敏的组分,可以在使用前除去它们。
所用的蛋白质组分优选包含足量的甲硫氨酸和赖氨酸。甲硫氨酸的比例优选为总氨基酸的1.8-6wt%(例如2.0-5.0wt%或2.3-4.0wt%)。赖氨酸在蛋白质中优选以总氨基酸的5.8-12.0wt%(如6.0-11.0wt%或6.5-10.0wt%)的量存在。色氨酸在蛋白质组分中优选以总氨基酸的1.5-4wt%的量(更优选以1.6-3.0wt.%的浓度范围)存在。亮氨酸优选地以总氨基酸的8.0wt%的量被包含,更优选8.5-35wt%,例如9-15wt%。
此外,所用的蛋白质组分的氨基酸组成优选具有高的丝氨酸/甘氨酸比例。在最终组合物中丝氨酸/甘氨酸比例优选为3.4或更高。
从植物组织如块茎或种子提取蛋白质或其水解可以采用本领域已知的方法进行。代替从天然来源提取蛋白质,也可以使用合成氨基酸。采用例如寡核苷酸合成仪,例如由Applied Biosystems Inc.(Fosters,CA,USA)供应的寡核苷酸合成仪,也可以从头合成具有期望的氨基酸组成的短肽。同样可能通过重组DNA方法,即通过在细菌宿主、植物或植物细胞培养物、动物细胞等中的表达,采用本领域已知的方法,制备具有期望的氨基酸组成的蛋白质或肽。
所述食品组合物或完全食品组合物优选包含足量的九种所谓的“必需”氨基酸(组氨酸、异亮氨酸、亮氨酸、赖氨酸、甲硫氨酸和/或半胱氨酸、苯丙氨酸和/或酪氨酸、苏氨酸、缬氨酸和色氨酸)。对于给予儿童的组合物,精氨酸也优选以足量存在,即基于蛋白质,多于3.8wt%,优选4.2wt%-7.2wt%。
明显地,上述蛋白质和/或氨基酸的任意混合物均可以用于制备用于所述食品或完全食品组合物中的期望的蛋白质组分。例如,可以将植物蛋白质提取物和合成氨基酸以期望的量混合,以制备具有期望的氨基酸组分和比例及期望的蛋白质/肽长度(分子量分布)的产品。
在一个实施方案中,所述食品或完全食品组合物优选包含至少一种以下组分:
半胱氨酸或半胱氨酸等价物,优选每日剂量至少0.2g,更优选每日剂量0.2-5g。半胱氨酸等价物例如可以选自以下之一种或多种:0.2-5g L-半胱氨酸、巯基乙胺、L-胱氨酸或L-胱氨酸二聚体;0.25-0.6g N-乙酰半胱氨酸;0.2-5g L-甲硫氨酸(或它们的任意组合)。
一种或多种核苷酸或核苷酸等价物,优选每日剂量至少0.2g,更优选每日剂量约0.2-5g。核苷酸等价物例如可以选自以下之一种或多种:1-10g酵母、胞苷、尿苷和/或核苷及核糖。
β-丙氨酸,优选每日剂量至少约0.1g,更优选每日剂量约0.1-5g。在组合物中所用的β-丙氨酸优选包含(R)-pantoate。
叶酸或叶酸等价物,优选每日剂量至少约300mg,更优选每日剂量约300-3000mg。叶酸等价物例如可以选自以下之一种或多种:单谷氨酸盐或多谷氨酸盐(还原和/或氧化形式)、一种碳变体如5-甲基、10-甲基-、5,10-亚甲基-、5-甲酰-或10-甲酰-叶酸。
维生素B6或其等价物,优选每日剂量至少约0.5mg,更优选每日剂量至少0.5-50mg。维生素B6等价物例如可以选自以下之一种或多种:吡哆醇、吡哆醛或吡哆胺。
优选包含维生素以获得最大的体重增加,特别是维生素叶酸、生物素、维生素B2和维生素B6。
优选地,硫辛酸的量少于50mg/L,更优选少于33mg/L,以避免味觉异常。
在另一实施方案中,在所述食品或完全食品组合物中包含脂质或脂质部分,其量为每100g组合物1.5g。更优选脂质的量为每100g组合物2.0-10g,最优选其为每100g组合物2.7-8g。所述脂质部分可以是甘油三酯、甘油二酯、甾醇、鞘脂、神经酰胺、磷脂、脂肪酸和脂肪酸酯。为获得最好效果,优选地,所述脂质部分具有相对大量的饱和脂肪酸尤其是肉豆蔻酸。饱和脂肪酸的量优选多于每100g脂肪酸12g,更优选为每100g脂肪酸14-50g。肉豆蔻酸的量优选多于每100g脂肪酸4.0g。优选地,以脂肪酸总量的百分比表示的肉豆蔻酸的量为6-40wt%,更优选约8-30wt%的浓度,例如10-20wt%。此外,可以存在棕榈酸,其量为多于9wt%,优选10-35wt%,例如每100g脂肪酸12-25g。
肉豆蔻酸优选以甘油三酯、磷脂、游离脂肪酸和/或其酯存在。合适的来源具有低于55摄氏度的熔点,优选低于50摄氏度。这通过分馏脂质并选择符合该标准的成分例如甘油三酯而实现。基于脂类来源中的脂肪酸量,这些甘油三酯通常含有少于12wt%,优选少于8wt%的硬脂酸。这些脂质包含相对大量的中链脂肪酸α-亚麻酸和油酸。后者通常高于15wt%,而α-亚麻酸的量超过12wt%。每100g脂肪酸中亚麻酸的量通常低于45g,优选低于38g,甚至更优选低于30g。
肉豆蔻酸的合适来源为游离脂肪酸和酯如丙酸酯(propionyl ester)或丁酸酯(butyryl ester)或鲸蜡酯(cetyl ester)。
在脂质混合物中相对大量的饱和脂肪酸使得不饱和脂肪酸如(n-3)、(n-6)和(n-9)系列的脂肪酸的量相对低。以每100g脂肪酸计,特别是(n-3)多不饱和脂肪酸的量低于30%,更优选低于25%,或甚至更好低于20%。为了防止味道变差,特别是二十碳五烯酸和二十二碳六烯酸的量相对低,例如,每100g脂肪酸1-16g。众所周知,这些脂肪酸极易氧化。因此优选包含(n-3)长链脂肪酸的量低于(n-6)长链脂肪酸的量。当产品中包含(n-3)长链脂肪酸时,优选包含它们以超过20%是亚麻酸。
所包含的磷脂,例如源自大豆、蛋或哺乳动物乳汁的磷脂的量可以为液体部分的2-50wt%,优选4-40wt%,最优选5-35wt%。尤其是可以使用富含卵磷脂的磷脂,例如,包含多于30%卵磷脂的磷脂且更优选多于液体部分的35wt%。
其它合适的胆碱来源为胆碱、甜菜碱、二甲基甘氨酸或肌氨酸。特别地,可以应用二甲基甘氨酸或甜菜碱来源,特别是甜菜碱及其盐,例如与有机酸的盐如柠檬酸盐、丙酮酸盐或苹果酸盐,其量为每日剂量至少0.5g。
在脂质部分中可以包含胆固醇,其量多于1wt%。优选该量为每100g脂质约2-10g,更优选为2.5-6wt%。可以包含多种形式的胆固醇,例如,作为纯的合成化合物或作为一种或多种类型的胆甾醇酯(cholesteryl-ester)。
如在临床营养物制备的现有技术中那样,可以包含矿物质。然而,钠的量应高于常规使用的量。钠水平优选总计为110-400mg/100ml液体组合物,更优选140-360mg/100ml组合物。
还优选包含可消化的糖类来源,其量为32-60en%。合适的来源是本领域技术人员已知的。
给予所述组合物的方法取决于所述组合物的剂型。所述组合物优选以任何液体剂型存在,例如饮料、酏剂、糖浆剂、气雾剂或混悬剂。或者,其可以为固体剂型(如胶囊剂、散剂或片剂)或者为半固体剂型(如凝胶剂、乳膏)。
给予途径可以为肠内(如口服,通过饮用/吞咽、管饲等)或胃肠外(如静脉内注射)。要理解,可以将每日剂量的量再分为更小的有效量,它们可在一天内于不同的时间给予。因而,当提到“每日剂量”或“日剂量”时,其不意味着所述剂量必须一次给予。根据本发明的组合物可以包含其它活性组分,如其它维生素(A、B1、B2、B3、B12、C、D、E、K等)、叶酸、益生素、益生元(prebiotics)等。所述组合物还可以包含其它无活性组分和载体,如葡萄糖、乳糖、蔗糖、甘露糖醇、淀粉、纤维素或纤维素衍生物、硬脂酸镁、硬脂酸、糖精钠、滑石粉、碳酸镁等。所述组合物还可以包含水、电解质、非必需氨基酸、微量元素、矿物质、纤维、甜味剂、调味剂、着色剂、稳定剂、防腐剂、粘合剂、芳香剂等。
当所述组合物是饮料时,优选每日所消费或给予(包含每日有效剂量)的体积在每日100-3000ml的范围内。尤其是在给予的最初几周中,每日小体积,如100ml、150ml或200ml可能是期望的。
在一个实施方案中,所述食品或完全食品组合物也可基于(即起始于或包含)食品基质(food base)制备。在一个实施方案中,所述食品或完全食品组合物基于或包含乳制品如发酵乳制品,包括但不限于牛奶、酸乳酪、酸乳酪基(yogurt-based)饮料或酪乳。这种组合物可以以本领域已知的方式制备,例如通过向合适的食品或食品基质中加入有效量的泛酸或至少一种其等价物来制备。其它合适的食品基质可以是植物基质、肉基质等。所有关于食品和完全食品组合物所描述的实施方案也适用于基于食品基质制备的组合物,例如最终组合物每日剂量优选包含至少14mg泛酸或其等价物。显然,如果所述食品基质本身已经含有一种或多种所述组合物的组分(例如泛酸、半胱氨酸等),则需要添加较少的这种组分,以达到所述最终组合物的期望剂量。
根据本发明的食品或完全食品组合物可作为治疗和/或预防性使用。也就是说,它们可以在个体已被诊断为食欲下降后给予,或者在食欲下降的症状出现之前给予。
通常任何正在经历或可能发生多于几天的食欲下降的个体均会受益于给予根据本发明的组合物。食欲下降可能有许多原因:感染(例如肺炎、肝炎、艾滋病、流感、肾盂肾炎);严重的肝、肾或心脏疾病,例如慢性肾衰竭、充血性心力衰竭、肝硬化;任何种类的癌症,例如但不限于结肠癌、胃癌、乳癌、白血病等;肠梗阻;炎性肠病,如胰腺炎、肠易激综合征、阑尾炎;内分泌问题,例如糖尿病或甲状腺机能减退;自体免疫疾病或病症,例如类风湿性关节炎、硬皮病;心理病症,例如抑郁或精神分裂症;进食障碍,如食欲缺乏或食欲过盛;药剂或毒品,尤其是化疗药、酒精、麻醉药或抗生素、糖尿病药(例如二甲双胍);妊娠;痴呆(例如阿尔茨海默病);肺疾病,例如肺气肿;手术后创伤,等等。
人的食欲缺乏通过拒绝食用正常每日量、不喜欢食物和/或饮料而容易在患者中识别。根据本发明的组合物可以在食欲下降的诊断后给予或预防性给予,例如预防性给予有发生食欲下降的高危险的个体。例如可以将所述组合物给予最近诊断为某种疾病或不适的个体,或在开始某项治疗前(例如在化疗前)等给予。使用完全食品组合物优选基本上代替正常营养物摄取,而优选除其它营养物之外给予食品组合物。
当在几周内,例如在至少2周,优选至少2-3周,更优选至少2-4或2-6周或更长时间内给予根据本发明的组合物时,在给药期间内,所述个体的体重优选保持基本上恒定(稳定),更优选增加。
作为给予根据本发明的组合物的另一有益效果,可以观察到个体的存活机会增加,可以观察到药物在个体中的毒性降低,可以观察到对胰岛素敏感性增加及癌症患者中转移发生的减少或消除。
本发明的另一实施方案提供根据本发明的组合物的制备方法,即适于治疗或预防食欲下降的组合物的制备方法。所述方法包括混合合适量的各种组分。泛酸或其等价物的合适量为每日剂量至少14mg,并且合适地将此剂量给予人。特别地,将合适量的泛酸或至少一种其等价物与一种或多种其它组分(例如其它营养物、氨基酸等,如上所述)混合。为了提供充足的营养物,至少蛋白质(或水解蛋白质或氨基酸)的存在是有益的。蛋白质(或水解蛋白质或氨基酸)应以至少15En%存在。因此,泛酸或至少一种其等价物生产用于刺激食欲的方法中的组合物的应用是本发明的一个实施方案。蛋白质(或水解蛋白质或氨基酸)和泛酸或其等价物生产用于刺激食欲的方法中的组合物的应用是本发明的另一实施方案,所述组合物包含至少15En%蛋白质(或水解蛋白质或氨基酸),并且其每日剂量包含至少14mg泛酸或其等价物。在另一实施方案中,提供泛酸或至少一种其等价物生产用于稳定和/或增加体重的方法中的组合物的应用。在另一实施方案中,提供泛酸或至少一种其等价物生产用于治疗和/或预防常发生于妊娠(早期)阶段的食欲下降的方法中的组合物的应用。在再一实施方案中,提供泛酸或至少一种其等价物生产用于治疗妊娠期间的恶心的方法中的组合物的应用。优选地,这些方法包括给予包含14-1000mg每日剂量的泛酸或其等价物的组合物。
要混入本文描述的组合物中的组分全部都是技术人员容易得到的。因此它们可以由本领域技术人员获得或制备。根据需要使用已知方法对组分的成分进行纯化、提取、混合、稳定和组合是本领域技术人员可以实现的。
泛酸可商购,但也可以如WO03/29476、WO03/13452和WO03/04673中所述合成生产,这些文献引入本文作为参考。泛酸的化学合成包括D-泛内酯与β-丙氨酸缩合。化合物在水中可自由溶解,在中性溶液中稳定,但在酸、碱和热条件下不稳定。
或者,泛酸可以自天然来源纯化,例如自经泛解酸和β-丙氨酸亚基的酰胺键合成泛酸的微生物(例如细菌)纯化。
泛酸的等价物也可如本领域已知获得或制备。例如,可商购的泛酸钙经1,1-二甲基-2-羟基丙醛和泛内酯从异丁醛和甲醛合成制备。
以下非限制性实施例描述了根据本发明的组合物。除非另外说明,本发明的实践会采用食品工艺学、分子生物学、病毒学、微生物学或化学的标准常规方法。
实施例
实施例1 组合物1
即饮(ready to drink)口服增补剂,其每100ml包含100keal、40en%蛋白质、41.1en%糖类和18.9en%脂质。
-蛋白质10.0g,其中4g豌豆蛋白水解产物,4g马铃薯蛋白水解产物,1.2g大豆蛋白分离物,0.2g甲硫氨酸,0.2g L-赖氨酸和0.2g L-亮氨酸,0.1g色氨酸,0.05g L-丝氨酸和0.05g N-乙酰半胱氨酸
-脂质2.1g,其基于乳脂、肉豆蔻酸、亚麻籽油和橄榄油,其包含15wt%肉豆蔻酸和15wt%棕榈酸
-基于麦芽糖糊精的糖类10.3g
-泛酸6mg
-叶酸150μg
-维生素B6 0.6mg
-生物素20μg
-钠1 50mg
本领域已知的临床营养一般推荐的其它微量营养物。
规定患者应消费至少250ml此即饮增补剂。
实施例2 组合物2
液体组合物,其每100ml包含166kcal能量:蛋白质提供18en%,可消化的糖类提供38.5%,而脂质提供43.4en%
-蛋白质为7.3g酸性乳清,加有0.2g L-甲硫氨酸
-脂质为8.0g的掺合物,其为椰子油、橄榄油、肉豆蔻烯酸鲸腊酯(cetyl-myristoleate)、大豆油的掺合物,其包含17wt%肉豆蔻酸
-糖类为16g的掺合物,其为麦芽糖糊精和葡萄糖浆的掺合物
加入维生素预混合料,其提供维生素A 164μg RE、1.4μg维生素D、2.5mgαTE、11μg维生素K、0.3mg硫胺、0.32mg核黄素、3.6mg NE烟酸、5mg泛酸、0.6mg维生素B6、100mg叶酸、0.6μg维生素B12、8μg生物素、20mg维生素C。
使用矿物质、微量元素预混合料,其提供200mg钠、200mg钾、120mg氯化物、80mg钙、75mg磷、45mg镁、3.2mg铁、2.4mg锌、360μg铜、0.66mg锰、0.2mg氟化物、20μg钼、11.4μg硒、13.4μg铬和26.6μg碘化物。
还包含200mg甜菜碱。
规定所述饮料应以每日600-800ml的量消费。
实施例3 组合物3
供以每100ml 21.5g的量在水中复制的散剂。
能量100kcal,其中蛋白质提供16en%,可消化的糖类提供49en%,而脂肪提供35en%。
-蛋白质为4.0g混合物,其为米蛋白水解产物和豌豆蛋白水解产物的混合物,加有0.1g L-丝氨酸、0.1g赖氨酸、0.05g L-甲硫氨酸和0.05g L-色氨酸
-脂质为3.9g混合物,其为30%卵磷脂和油与肉豆蔻酸的混合物的混合物;后者的量为18g/100g脂肪酸,
-糖类为12.2g混合物,其为麦芽糖糊精与1g核糖的混合物。
除其水平为本领域已知的其它微量成分以外,所述矿物质和维生素预混合料还提供2mg S-乙酰泛酰巯基乙胺、35μg叶酸、0.35mg吡哆醛、150mg钠,。
二甲基甘氨酸为0.2g。
所包含的呋喃-低聚糖(安茴酰牛扁碱(inuline)和水解菊粉的掺合物)的量为1.0g。
规定每日应消费1500-2000ml的量的复制饮料。
实施例4
还可以设计动物实验以测定泛酸的食欲刺激作用。例如,使用到达时3月龄体重±240g的雄性Wistar大鼠(HsdCpb:WU,Harlan,The Netherlands)。通过例如诱导癌症、压力、手术或任何其它相关处理在动物中诱导食欲下降。除非另外提及,将大鼠置于20±1℃下,光照从23.00h(ZT 0)直到11.00h(ZT 12),随意取食水和食物(RMH-B标准实验室食物,Hope Farms Woerden,The Netherlands)。
根据Strubbe等,Physiol Behav.1986,36:489-493描述的方法,大鼠异氟醚/氧/氮氧化物麻醉下在胃部接受永久性硅酮插管(I.D.0.6mm,O.D.1.2mm)。进行该操作以允许将化合物频繁且无压力地胃内给予自由活动的大鼠。允许七天的恢复期,直到动物恢复它们的术前体重。
手术后,将大鼠单独豢养在笼中,所述笼适于在线监测食物和饮料消费(UgoBasile,Italy)。在单次(安慰剂对照交叉)试验中监测包含泛酸或至少一种其等价物的组合物对食物和水消费的影响。每个单次试验持续4天(96小时)。每日记录体重。
在第一天,在关灯前两小时(ZT 10.00)将食物移除。在ZT 11.30,随机选定的大鼠通过胃插管接受包含泛酸或至少一种其等价物的组合物(溶解在总共1ml的水中)或仅接受等容的水。在ZT 12.00,将食物放回,并在给予后1、2、3、4、5、6、12、24和48h监测食物和饮料摄取。
在第三天,重复第一天的方案。在第一天接受包含泛酸或至少一种其等价物的组合物的大鼠现在接受赋形剂,反之亦然。同样在ZT12.00将食物放回,并在1、2、3、4、5、6、12、24和48小时监测食物和水消费。
Claims (17)
1.用于刺激食欲的组合物,其每日剂量包含14-1000mg泛酸或其等价物和至少15En%蛋白质(或水解蛋白质或氨基酸)和/或至少32En%糖类和/或至少18En%脂质,并且所述组合物每日剂量的热值为至少100kcal。
2.根据权利要求1的组合物,其中所述蛋白质选自来自植物、蔬菜、谷类、种子或乳清的蛋白质,优选来自酸性乳清的蛋白质。
3.根据权利要求1或2的组合物,其中所述组合物包含蛋白质,所述蛋白质每100g氨基酸提供以下至少之一:1.8-6g甲硫氨酸、5.8-12.0g赖氨酸、1.5-4.0g色氨酸和至少8.0g亮氨酸。
4.根据前述权利要求之任一项的组合物,其中丝氨酸/甘氨酸比例为3.4或更高。
5.根据前述权利要求之任一项的组合物,其每日剂量包含至少一种选自以下的组分:0.2-5g半胱氨酸或一种或多种半胱氨酸等价物、0.2-5g核苷酸或一种或多种核苷酸等价物(1-10g酵母、胞苷、尿苷、核苷)、0.1-5g β-丙氨酸(仅在泛酸的等价物为(R)-pantoate时)、300-3000mg叶酸或一种或多种叶酸等价物和0.5-50mg维生素B6或一种或多种维生素B6等价物、0.5g至少一种选自胆碱、甜菜碱、二甲基甘氨酸和肌氨酸的组分。
6.根据前述权利要求之任一项的组合物,所述组合物每日剂量的热值为至少600kcal,优选至少900kcal,更优选至少1200kcal。
7.根据前述权利要求之任一项的组合物,其每100g组合物包含至少1.5g脂质,优选2.0-10g,更优选2.7-8g。
8.根据权利要求7的组合物,其中脂质的量为每100g脂质包含至少12g饱和脂肪酸,优选每100g脂肪酸包含14-50g。
9.根据权利要求7或8的组合物,其中脂质的量为每100g脂肪酸包含至少4.0g肉豆蔻酸。
10.根据前述权利要求之任一项的组合物,其包含至少15En%蛋白质(或水解蛋白质或氨基酸)和至少25En%脂质和至少40En%糖类。
11.蛋白质(或水解蛋白质或氨基酸)和泛酸或其等价物生产用于刺激食欲的方法中的组合物的应用,所述组合物包含至少15En%蛋白质(或水解蛋白质或氨基酸),并且其每日剂量包含至少14mg泛酸或其等价物。
12.根据权利要求11的应用,其中所述方法包括稳定和/或增加体重。
13.根据权利要求11或12的应用,其中所述方法包括给予一种组合物,其包含14-1000mg的每日剂量的泛酸或其等价物。
14.根据权利要求11-13之任一项的应用,其中所述泛酸或其等价物选自泛醇、(R)-pantoate或其盐或酯、泛酸或其盐或酯或醚、泛酰巯基乙胺或其酯或醚和辅酶A,优选泛醇、(R)-pantoate或其盐或酯和泛酰巯基乙胺或其酯或盐。
15.根据权利要求11-14之任一项的应用,其中所述方法用于治疗患有以下疾病的患者:感染,严重的肝、肾或心脏疾病,任何种类的癌症,肠梗阻,炎性肠病,胰腺炎,肠易激综合征,阑尾炎,内分泌问题,糖尿病,甲状腺机能减退,自体免疫疾病或病症,心理病症,进食障碍,药物或毒品、化疗药、酒精、麻醉药、抗生素、糖尿病药的不利作用,痴呆,肺疾病,肺气肿,手术后创伤。
16.根据权利要求11-14之任一项的应用,其用于治疗妊娠期间的恶心的方法中。
17.根据权利要求1-10之任一项的组合物的应用,其根据权利要求11-16之任一项应用。
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-
2004
- 2004-12-24 WO PCT/NL2004/000910 patent/WO2005060952A1/en active Application Filing
- 2004-12-24 US US10/584,510 patent/US8388949B2/en not_active Expired - Fee Related
- 2004-12-24 EP EP10186192A patent/EP2311448A1/en not_active Withdrawn
- 2004-12-24 EP EP04808826A patent/EP1699447B1/en not_active Not-in-force
- 2004-12-24 DE DE602004016385T patent/DE602004016385D1/de active Active
- 2004-12-24 EP EP08163489A patent/EP2002830A1/en not_active Withdrawn
- 2004-12-24 CN CNA200480042052XA patent/CN1921842A/zh active Pending
- 2004-12-24 ES ES04808826T patent/ES2314485T3/es active Active
- 2004-12-24 AT AT04808826T patent/ATE406884T1/de not_active IP Right Cessation
- 2004-12-24 JP JP2006546872A patent/JP2007517026A/ja active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103717230A (zh) * | 2011-07-22 | 2014-04-09 | 费森尤斯卡比德国有限公司 | 用于肥胖症重症患者的胃肠外营养的产品 |
CN104812254A (zh) * | 2012-07-05 | 2015-07-29 | N.V.努特里西阿公司 | 用于治疗营养物或药剂的胃肠副作用的膳食纤维 |
CN104812254B (zh) * | 2012-07-05 | 2018-08-31 | N.V.努特里西阿公司 | 用于治疗营养物或药剂的胃肠副作用的膳食纤维 |
WO2020215356A1 (zh) * | 2019-04-25 | 2020-10-29 | 瑞微(深圳)生物科技有限公司 | 泛酸在制备用于治疗和/或预防肿瘤的组合物中的应用 |
Also Published As
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ATE406884T1 (de) | 2008-09-15 |
JP2007517026A (ja) | 2007-06-28 |
EP1699447B1 (en) | 2008-09-03 |
WO2005060952A1 (en) | 2005-07-07 |
EP2311448A1 (en) | 2011-04-20 |
DE602004016385D1 (de) | 2008-10-16 |
EP2002830A1 (en) | 2008-12-17 |
US20080031860A1 (en) | 2008-02-07 |
US8388949B2 (en) | 2013-03-05 |
ES2314485T3 (es) | 2009-03-16 |
EP1699447A1 (en) | 2006-09-13 |
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