CN101277617A - 治疗肌肉萎缩的含甜菜碱的营养品 - Google Patents
治疗肌肉萎缩的含甜菜碱的营养品 Download PDFInfo
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Abstract
本发明涉及治疗人肌肉萎缩或者降低其发病率,并且涉及一种用于患有肌肉萎缩的患者的完全营养组合物,所述组合物包含甜菜碱并优选地包含辅酶Q10。
Description
技术领域
本发明涉及一种营养组合物,所述营养组合物用于在需要它的患者中治疗肌肉萎缩。具体地说,本发明涉及一种用于肌肉萎缩患者的完全营养组合物。合适的所述营养品为一种饮料、粉末或条块的形式。
背景技术
在肌肉萎缩患者中,蛋白分解和蛋白合成之间正常存在的平衡被破坏。这导致体重不自主地下降至少总体重的5%。肌肉萎缩可能发生在癌症的末期(与癌症的类型有关),也可能发生在受到严重的创伤或外科手术之后,并且与衰老(例如患有痴呆的患者)、严重疾病以及烧伤有关,所述严重疾病例如慢性炎症,如慢性阻塞性肺疾患(COPD)患者,以及严重感染疾病,如AIDS。在HIV感染的各个阶段的人中已经观察到无脂肪肌肉重量的减轻。肌肉萎缩与饥饿的区别是,前者会保持体脂肪含量不变而体细胞重量减轻。这种进行性萎缩可能仅仅起因于潜在的HIV感染。体重不自主地和进行性地下降至少体重的5%并最终伴随虚弱,或者体细胞重量显著减轻是存在肌肉萎缩的标志。体重降低通常会涉及到与死亡率升高,而且还伴有例如感染和食欲不振、肌无力和容易疲劳等并发症的更频繁发作。
WO9402036公开了一种为人的合成代谢的生理状态提供持续的能量和营养支持的组合物。据称,所述组合物对常伴有恶病质等的生理应激反应的患者有益处。因此,本文件解决这个问题的方法是为恶病质患者提供一种持续的能量和合成代谢的营养组合物。所述组合物包含一种混合物,所述混合物含有简单的糖和更复杂的糖、部分水解的蛋白质和至少是以氨基酸螯合形式存在的镁。
未公布的欧洲专利申请04076132.2公开了将富含蛋白质的配方应用于改善癌症相关的恶病质症状。
US2004043013公开了用于对一种解偶联治疗提供支持的组合物。这项治疗导致ATP产生的减少,这与本申请的发明人希望通过添加含甜菜碱和CoQ10的营养物诱导的效应相反。实施例3公开了将包含甜菜碱和CoQ10的组合物应用于肥胖患者以诱使体重减轻。这与本发明所声称的效果相反。该文件的实施例12描述了一种应用于癌症患者的组合物。在这个实施例中提出的制剂既不包含甜菜碱也不包含CoQ10。
本发明的一个目的是提供一种包含最佳选择的成分的组合物,以通过提高细胞的含能量来改善蛋白分解和合成之间的平衡。
发明内容
肌肉萎缩患者具有的症状例如体重减轻、食欲下降、肌无力和疲劳等。本发明的发明人惊奇地发现,食用甜菜碱或其等价物对肌肉萎缩患者有显著的益处,并且所述甜菜碱或其等价物优选地与辅酶Q10或其等价物联合使用。所述益处包括总体重减少程度降低、非脂肪体重减少程度降低,疲劳状况改善(因此疲劳减少)并且活力提高。本发明的应用特别有益于治疗或减轻涉及下列情况的肌肉萎缩:创伤、移植、严重缺血/再灌注损伤、烧伤和外科手术以及其他的大量组织需要替换的病症。患COPD的非外科手术患者、例如HIV/AIDS等严重感染性疾病和衰老患者,例如痴呆患者,也会从本发明受益。
本发明人惊奇地发现,甜菜碱(三甲基甘氨酸)的使用显著地提高肌肉中的糖原能量贮存。辅酶Q10可以促进所增加的能量贮存的有效利用,从而增强甜菜碱的效果并且缓和肌肉组织的萎缩。
提高肌肉组织中的细胞内能量贮存对肌肉萎缩患者有益处,并且对肌肉萎缩的癌症患者特别有益处,因为这可以改善上述的肌肉萎缩患者中低细胞内能量贮存水平相关的症状。本发明因此涉及使用甜菜碱等价物制备一种营养组合物,所述营养组合物用于治疗需要它的患者的肌肉萎缩或降低其发病率。优选地,甜菜碱与辅酶Q10等价物(CoQ10)组合用于制备一种营养组合物,所述营养组合物用于治疗需要它的患者的肌肉萎缩或降低其发病率。在一个实施方案中,本发明涉及对肌肉萎缩的癌症患者的治疗。然而,本发明的应用对由其他原因引起的肌肉萎缩的所有患者都有益处,例如创伤或外科手术患者和COPD或HIV感染的患者。
在一个优选的实施方案中,CoQ10和甜菜碱与一种可为所述患者提供充足的蛋白质、碳水化合物和脂肪的完全营养配方组合使用以预防或恢复所述患者的体重下降。
具体实施方式
如前文所述,肌肉萎缩可以破坏蛋白分解和蛋白合成之间正常存在的稳态。这会导致体重不自主下降至少总体重的5%。当出现体重显著地减少(三个月内超过5%)或者体细胞重量显著地减少(3个月内超过5%)的时候,表示需要本发明的营养疗法。另外,当体重指数(BMI)低于18.5kg/m2的时候需要考虑进行营养治疗。
本发明提供的营养组合物可以改善蛋白分解和蛋白合成之间的平衡,从而减轻肌肉萎缩症状,例如提高非脂肪体重。
因此,肌肉中充足的能量贮存有益于改善蛋白分解和蛋白合成之间的平衡,从而提高非脂肪体重。
甜菜碱(Betaine)也称为三甲基甘氨酸、N-三甲基甘氨酸、甘氨酸甜菜碱(glycine betaine)、氨基乙酸甜菜碱(glycocoll betaine)、oxyneurine和甘氨酸三甲内盐(lycine)。它的化学名称是1-羧基-N,N,N-三甲基甲铵内盐。甜菜碱的分子式是C5H11NO2,它的化学式是(CH3)3N+-CH2COO-。甜菜碱的氢氯化物被称为盐酸甜菜碱,甜菜碱HCl和pluchine。它的化学名称是氯化1-羧基-N,N,N-三甲基甲铵。
甜菜碱高半胱氨酸甲基转移酶(BHMT)是锌金属酶,它催化将甲基从甜菜碱转移到高半胱氨酸形成甲硫氨酸的反应。在肝脏和肾脏中发现存在BHMT,并且它也存在于脑组织中。甜菜碱也可以通过该酶降低某些原发性高同型半胱氨酸血症/同型胱氨酸尿症患者中的高半胱氨酸水平。在某些动物研究中,也再次发现甜菜碱可以通过BHMT降低高半胱氨酸的水平。
甜菜碱等价物被限定为无水和水合形式的甜菜碱、二甲基甘氨酸、甜菜碱内盐以及所述分子与例如氢氯酸等的无机酸或者例如柠檬酸、苹果酸、天冬氨酸或肌氨酸等的有机酸结合的形式。在一个优选的实施方案中,使用甜菜碱、二甲基甘氨酸或其组合。在最优选的实施方案中使用甜菜碱。
对于本发明而言,甜菜碱的一种合适的天然来源是属于藜科(Chenopodiaceae)的植物,例如甜菜的糖蜜天然富含甜菜碱。甜菜碱的优选剂量是每天50-50000mg,更优选每天100-10000mg,最优选每天1000-10000mg。其他甜菜碱等价物的优选剂量按照甜菜碱的摩尔量换算。
辅酶Q10(也称作CoQ10、Q10、维生素Q10、泛醌和癸稀醌)是一种由人体天然合成的苯醌化合物。名称中的“Q”和“10”分别指醌化学基团和10个异戊二烯化学亚基,所述基团和亚基是该化合物结构的一部分。术语“辅酶”表示它是一种有机(含有碳原子)的、非蛋白分子,所述分子对它的蛋白配偶体(一种酶或者酶复合体)的正常功能发挥是必需的。辅酶Q10被机体细胞应用于某个过程,该过程有有氧呼吸、有氧代谢、氧化代谢或细胞呼吸多种称谓。通过这个过程,细胞生长和维持需要的能量在细胞内的被称为线粒体的小室中形成。在人体中,补充剂量和服药日程可以变化,但是优选的范围是10-2000mg/天,更优选是20-1000mg/天,最优选90-390mg/天。虽然异戊二烯单元的数量优选是10,但是8、9或12个单元的数量在人体中可以得到相似的活性。
所有这些化合物被称为CoQ10等价物。该术语也包括将在下文详述的合成的等价物。
已经注意到,CoQ10可以达到很高的血浆水平,而进入组织中的可能很少(Valliant F.et al,1996.J.Bioenerg.Biomembr,28:531-540)。因此,本发明包括使用合成的CoQ10等价物,特别是与CoQ10相比显示药物代谢动力学得到改善的等价物。一种这样的等价物是艾地苯醌(idebenone,2,3-二甲氧-5-甲基-6-(10-羟基)癸基-1,4-苯醌),它是一种容易通过细胞膜的短链醌。因此在一个实施方案中,本发明涉及使用艾地苯醌作为CoQ10的等价物。
适合本发明的CoQ10等价物的天然来源包括真菌、酵母或细菌的提取物或分离物、芸苔油(canola oil)或大豆油。
一个优选的实施方案包括使用维生素B6。因为该维生素对于患者中天然CoQ10的生物合成是必需的,所以当使用较低剂量的辅酶Q10的时候,使用该维生素可以提高所述营养配方的效果。当每天的剂量低于20mg CoQ10的时候,给予超过2mg的维生素B6会增加内源性CoQ10的水平。维生素B6可以以本领域已知的形式和方法给予,例如像吡哆辛(pyridoxine)、吡哆胺(pyridoxamine)、吡哆醛(pyridoxal)或磷酸吡哆醛。
并不期望拘囿于任何理论,甜菜碱对糖原形成的作用可能要归因于甜菜碱作为甲基供体的功能。可以通过测量非脂肪体重的变化速率或者通过测量糖原能量贮存来定量测定通过使用本发明产生的改善的效果。也可以通过测量甜菜碱的使用率确定所述改善的效果,例如,通过测量甜菜碱代谢物的比例,如二甲基甘氨酸与肌氨酸或甘氨酸的比例。
已发现,在所述产品中加入叶酸盐(酯)可进一步地增加甜菜碱的正面效果。具体地,每日剂量中包含超过400μg的叶酸盐(酯)显示出有益效果。叶酸盐(酯)也被称作维生素B-9、叶酸;蝶酰谷氨酸。该组分可以增加体内四氢叶酸或它的甲基化形式的水平。叶酸盐(酯)可以被用作叶酸,所述叶酸盐(酯)可为氧化的形式或还原的形式,或者单或多谷氨酸盐(酯)的形式,以及亚叶酸或甲基化的形式,所有这些形式都称为叶酸盐(酯)和叶酸盐(酯)等价物。因此在一个进一步的实施方案中,本发明包括使用叶酸盐(酯)或其等价物。
营养组合物
本发明的营养组合物的使用对肌肉萎缩患者有益处。所述营养组合物可以具有不同的能量密度,但是因为肌肉萎缩患者经常热卡摄取量不足,所以所述能量密度优选较高。当以液体的形式的时候,所述组合物应该包含至少0.9kcal/ml,优选至少1.0kcal/ml,最优选至少1.5kcal/ml。每天给予至少100ml的所述液体组合物的单剂量,也可以分多个剂量,或者可以采用肠管饲食法(enteral tube feedingregimens)。特别是在家庭中,当患者缺乏食欲的时候,夜间管喂食是一种很舒适的最佳的营养摄取方式。完全营养配方特别有益处,因为肌肉萎缩患者经常缺乏足够的营养支持并且需要常量营养物,如蛋白质、脂肪和碳水化合物,以及微量营养物,如维生素和矿物质。
在一个优选的实施方案中,所述营养组合物包含甜菜碱、CoQ10、至少15en%的脂质(优选15-70en%的脂质)、10-70en%的可消化碳水化合物和10-35en%的蛋白质,其中所述蛋白质包含所有的必需氨基酸并且所述蛋白质的来源选自于乳蛋白、卵蛋白、植物蛋白和它们的水解产物。优选地,甜菜碱和/或其等价物的浓度是0.01-500mg/ml,CoQ10和/或其等价物的浓度是0.002-20mg/ml。在一个更加优选的实施方案中,所述完全配方具有多于15en%的脂质含量(优选地在27-80en%,更优选在37-70en%,最优选42-70en)、20-50en%的可消化碳水化合物和10-35en%的蛋白质。
在一个优选的实施方案中,所述营养组合物包含提供EPA的脂质部分,其中EPA含量超过所述脂质部分的2wt%。
另一个优选的实施方案进一步包含叶酸盐(酯)和/或维生素B6,其中优选的叶酸盐(酯)的浓度是0.0005-0.05mg/ml并且其中维生素B6的浓度是0.001-0.07mg/ml。
优选一种富含亮氨酸的蛋白质组合物。亮氨酸的量是蛋白质部分的10.7-20%,更优选11.2-19.1重量%。为了限制游离氨基酸的量,优选少于20wt%的蛋白质部分是游离氨基酸的形式。优选地,亮氨酸与缬氨酸+异亮氨酸+亮氨酸的总量的比大于0.48。
特别优选将所述组合物与一种具体的服药法结合。具体地,当本发明的一种组合物与多柔比星(doxorubicin)、β-阻断剂和他汀类药物(statins)联合使用的时候,可以显著地减少肌肉萎缩。
实施例
实施例1
本发明人惊奇地发现,甜菜碱(三甲基甘氨酸)的使用可以显著地提高正常健康大鼠肌肉中的糖原能量贮存。
表1显示出补充口服香草乳蛋软冻(vanilla custard)(对照组)和含甜菜碱的香草乳蛋软冻的大鼠肌肉组织中的静息糖原水平。甜菜碱显著地增加肌肉细胞的糖原含量。
表1.大鼠中的静息糖原水平(μmol糖基单元/g组织)
肌肉类型 | 不补充甜菜碱 | 补充甜菜碱 |
EDL | 108±7 | 120+4* |
比目鱼肌 | 107±12 | 137±16* |
*P<0.05
研究设计和方法
在8只雄性Wistar大鼠上进行实验,所述大鼠重250-300克,分笼圈养,并且自由获得食物和水。所有的实验步骤经荷兰实验动物管理及使用委员会(Institutional Animal Care and Use Committee)批准,并遵守实验动物管理的规定。为了确定口服补充甜菜碱的效果,所述甜菜碱组(n=4)每天接受含60mg甜菜碱(Sigma Aldrich)的1ml香草乳蛋软冻,对照组(n=4)接受1ml香草乳蛋软冻。经过6周的补充给药,取快收缩趾长伸肌(EDL)和慢收缩(比目鱼肌)肌肉用于进一步生物化学分析并且被冷冻在液氮中。将肌肉保存在-80℃直至进行分析。之后,在-4℃下将肌肉冷冻干燥3天。将所述冷冻干燥的肌肉磨成粉,向大约10mg组织中加入400μl 1M HCl,在98℃下水解2个小时。在冷却之后加入400μl 1M NaOH进行样品的中和,并且所述样品以13,000rpm离心5分钟。用一种葡萄糖试剂盒(RocheDiagnostics)通过荧光法测定糖原含量并表示为μmol糖基单元·g-1。
实施例2营养补充剂
用于治疗或预防肌肉萎缩的营养补充剂可为片剂的形式,所述片剂包含:1g甜菜碱、100mg CoQ10和0.4mg维生素B6、0.20mg叶酸。一种建议的日剂量是每天2-4片。所述成分中的一种或多种可以被其等价物替代。
实施例3临床营养品
用于治疗和预防肌肉萎缩的液体临床营养品的一个优选的实施方案包含如下成分:
成分 能量百分比 g/100ml
蛋白质 26 10
碳水化合物 47 18
脂质 28 5.3
纤维 2.1
甜菜碱 2
CoQ10 0.12
维生素B6 0.00068
叶酸 0.0004
其他维生素 0.1-1倍RDA水平
其中所述蛋白质包含所有的必需氨基酸并且所述蛋白质的来源选自于乳蛋白、卵蛋白、植物蛋白和它们的水解产物,所述脂质优选地包含例如EPA等的n-3脂肪酸,优选至少5wt%的总脂质,并更优选至少10wt%的脂质由EPA构成。
实施例4.用于非脂肪体重不自主减轻的外科手术患者的液体配方,每100ml包含。
酪蛋白 6.1g
L-亮氨酸 0.2g
脂质 4.9g,含0.2g角鲨烷和0.1g EPA
甜菜碱 0.12g
二甲基甘氨酸 0.02g
维生素矿物质,每100kcal:
维生素A 82μg
类胡萝卜素 0.20mg
维生素D 0.7μg
维生素E 1.3mg
维生素K 5.3μg
硫胺素 0.15mg
核黄素 0.16mg
烟酸 1.8mg
泛酸 0.53μg
维生素B6 0.17μg
叶酸 27μg
维生素B12 0.21μg
生物素 4.0μg
维生素C. 10mg
实施例5.用于HIV感染引起的非脂肪体重不自主减轻的患者的营养条块,包括。
原料 蛋白质 碳水化合物 脂肪 g/100g
初乳 15.00 2.10 0.80 21.04
硫璃苣油 0.00 0.00 4.00 4.21
EPA-DHA油(Maruha) 0.00 0.00 6.00 6.31
卵蛋白 16.87 0.00 0.00 22.19
果糖糖浆 0.00 11.92 0.00 16.20
甘油 0.00 3.83 0.00 4.05
CoQ10 0.35
维生素B6 0.0024
叶酸 0.0012
甜菜碱 3.0
Claims (12)
1.甜菜碱等价物在制备一种营养组合物中的应用,所述营养组合物用于治疗需要它的患者中的肌肉萎缩或者降低其发病率。
2.根据权利要求1的应用,其中所述组合物进一步包含辅酶Q10(CoQ10)等价物。
3.根据权利要求1或2的应用,其中所述患者患有癌症、HIV或手术创伤。
4.根据权利要求1-3任一项的应用,其中所述组合物进一步包含叶酸盐或叶酸酯或者其等价物。
5.根据权利要求1-4任一项的应用,其中所述组合物还包含维生素B6。
6.根据权利要求1-5任一项的应用,其中所述甜菜碱和/或其等价物的剂量是50-50000mg/天。
7.根据权利要求1-6任一项的应用,其中所述CoQ10和/或其等价物的剂量是10-2000mg/天。
8.一种营养组合物,所述营养组合物包含甜菜碱、CoQ10、至少15en%的脂质、10-70en%的可消化碳水化合物和10-35en%的蛋白质,其中所述蛋白质包含所有的必需氨基酸并且所述蛋白质的来源选自于乳蛋白、卵蛋白、植物蛋白和它们的水解产物。
9.根据权利要求8的营养组合物,其中所述营养组合物进一步包含维生素B6,和/或叶酸盐或叶酸酯。
10.根据权利要求8或9的营养组合物,其中所述甜菜碱和/或其等价物的浓度是0.01-500mg/ml,并且CoQ10和/或其等价物的浓度是0.002-20mg/ml。
11.根据权利要求8-10任一项的营养组合物,其中所述叶酸盐或叶酸酯的浓度是0.0005-0.05mg/ml。
12.根据权利要求8-11任一项的营养组合物,其中所述维生素B6的浓度是0.001-0.07mg/ml。
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CN115868634A (zh) * | 2021-09-28 | 2023-03-31 | 深圳芙莱特营养与健康有限公司 | 一种增强耐力的组合物 |
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