CN101198337A - 含有初乳和epa或dha或gla的营养添加剂 - Google Patents
含有初乳和epa或dha或gla的营养添加剂 Download PDFInfo
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- CN101198337A CN101198337A CNA2005800500942A CN200580050094A CN101198337A CN 101198337 A CN101198337 A CN 101198337A CN A2005800500942 A CNA2005800500942 A CN A2005800500942A CN 200580050094 A CN200580050094 A CN 200580050094A CN 101198337 A CN101198337 A CN 101198337A
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- alimentation composition
- cysteine
- colostrum
- fat blend
- epa
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Abstract
本发明涉及一种包含初乳和脂肪混合物营养组合物,特别适合于对HIV患者的肠道功能障碍进行治疗。
Description
技术领域
本发明涉及到一种营养组合物。特别地,本发明涉及到营养组合物用于治疗HIV患者的肠道功能障碍的用途。
背景技术
HIV患者的肠道功能障碍是病毒感染和炎症反应两者共同作用的结果。肠道功能障碍经常与肠中的炎性病症相关。肠通透性的增加或肠道屏障机能的不足是慢性炎症疾病、变态反应、食物中毒和HIV感染的患者中常见的病理特征。
先前已经提出了营养解决方案。WO2004/112509中描述了一种用于使新生婴儿体内肠道屏障成熟最优化的营养处方。所提出的处方包含至少一种微生物、EPA和不可消化的寡糖。
本发明人在以前的一个申请(PCT/NL2004/000444)中描述了多不饱和脂肪酸、特别是二十碳五烯酸(EPA)、二十二碳六烯酸(DHA)和花生四烯酸(ARA)能够有效地改善肠道屏障的抵抗力和减少肠道紧密连接的通透性。它进一步描述了可以使用ARA的前体——γ-亚麻酸(GLA),而对效力没有负面影响。
发明内容
本发明提供一种选定的多不饱和脂肪酸(PUFA)和初乳的组合物。该PUFA和初乳的组合物能够通过改善屏障完整性和支持组织再生来有效地增强肠功能。肠道屏障完整性是通过协同性地减小肠通透性和改善粘液产生来改善的。后者对于改善HIV患者(更具体地说是成年HIV患者)体内屏障完整性特别重要,所述HIV患者遭受着肠内炎性病症的攻击。
令人惊奇的是,本发明人发现初乳能与PUFA协同作用来减小肠通透性并支持组织再生,从而改善肠道功能。
因此在一个实施方案中本发明涉及一种包含初乳和含有EPA的脂肪混合物的组合物。优选地,EPA占总脂肪混合物重量的10-40%。在另一个实施方案中本发明组合物中的脂肪混合物还包含DHA,优选的脂肪混合物包含占总脂肪混合物的1-25wt%的DHA。在另一个实施方案中本发明组合物中的脂肪混合物进一步可包含GLA,优选的脂肪混合物进一步还包含占总脂肪混合物的1-15wt%的GLA。还在另外一个实施方案中本发明组合物中的脂肪混合物进一步还包含DHA和GLA,优选的具体含量为上文限定的量。
本发明的一个方面是初乳和包含EPA的脂肪混合物用于制备营养组合物的用途,所述营养组合物用于预防和/或治疗HIV患者的肠道功能障碍。
具体实施方式
据估计,最多有25-30%的没有实质性临床症状的HIV感染患者具有异常的肠道功能,例如营养吸收的下降和/或由于肠的粘膜上皮层泄漏而产生的通透性的增加。已经知道,肠道功能障碍的这些方面的发病率会在疾病发展过程中不断提高。实际上,认为最终几乎所有的AIDS患者都会具有不同程度的肠道功能障碍。本发明的合剂可以有利地被用于改善HIV患者的肠道功能。
不受限于理论,在图1中给出了一张流程图,其中涉及到的因子被描述为在HIV感染过程中会导致异常的肠道功能,所述异常的肠道功能的最终特征在于例如腹泻、感染和吸收不良的临床特征。
用HIV感染肠细胞被认为会产生炎性反应,该炎性反应最终会导致HIV患者中经常出现的胃肠(GI)症状,例如腹泻、其他感染和吸收不良。该反应可能是由炎性反应直接介导或由肠屏障损伤或肠病(吸收和粘液产生减少)间接介导。本文提出的成分都在所述流程图的一个或多个方向中起作用。
初乳
初乳是雌性哺乳动物(特别是母牛)在分娩后乳腺中分泌的初乳液。初乳包含许多生物活性成分,因此是生物活性分子例如生长因子和免疫球蛋白的一种极好来源。初乳可以是液体形式或者干燥形式。在本发明的上下文中,合适的初乳为浓缩蛋白粉形式,所述浓缩蛋白粉可以按照例如US6202546中所述来制备。商品初乳粉包含大约70-80wt%的蛋白。液态初乳包含4-20wt%的蛋白。
本文的初乳蛋白是指液态初乳或固态初乳(例如浓缩蛋白粉)中存在的蛋白成分。优选地,该蛋白基本上是未变性的,使得该蛋白组分中存在的生物活性分子是有活性的。
为了在HIV患者中获得有益的效果,每天提供大约5至50克的初乳蛋白,优选每天10至30克,最优选每天约15g初乳蛋白。如前文所述,商品初乳粉包含约70-80wt%的蛋白。因此本发明产品的日剂量中包含大约6至75g初乳粉。优选地提供足够量的初乳,使得每天提供至少1克的免疫球蛋白G,优选1-10克,最优选2-8克免疫球蛋白G。
初乳或乳的提取物,例如EP0545946中描述的乳清生长因子提取物或者WO/02083164中描述的酪蛋白提取物、免疫球蛋白浓缩物、乳铁蛋白或其他浓缩的乳清组分,也可以被用来改善HIV患者的肠道屏障机能。不受限于理论,认为生长因子和/或抗体参与改善肠道组织的再生,从而改善肠的完整性。优选地,该初乳或乳清提取液包含的免疫球蛋白和生长因子的量与从分娩后1-5天内(优选分娩后1-3天)的母牛的新鲜初乳中存在的免疫球蛋白和生长因子的量至少相同或更高。基于干重,初乳中免疫球蛋白G的量优选地为20-40wt%。在初乳中存在的生长因子包括(但不限于)胰岛素样生长因子1和2、转化生长因子1和2、β-动物纤维素、KGF和本领域技术人员已知的其他生长因子。优选地,这些生长因子的浓度至少与新鲜液态初乳中生长因子浓度在相同的范围内(基于干重),新鲜液态初乳中生长因子的浓度通常是已知的或可以被测量的。使用提取物的优势是:在蛋白的量不必增加太多的前提下,就能够提高本发明产品的免疫球蛋白和生长因子的含量。
多不饱和脂肪酸
在本发明中,术语脂肪混合物是指一种组合物,至少包括EPA和至少一种属于n-3脂肪酸组和/或n-6脂肪酸组的其他脂肪酸。
如前文所述的多不饱和脂肪酸,特别是二十碳五烯酸(EPA,C20:5n-3)、二十二碳六烯酸(DHA)和花生四烯酸(ARA)能够有效地减少肠道紧密连接的通透性。也可以使用ARA前体——γ-亚麻酸(GLA,C18:3n-6),而对效力没有负面影响。这样是有优势的,因为GLA的炎性反应比ARA小。因此,优选的脂肪混合物包括EPA和DHA(任选地)和/或含有GLA。上述的脂肪酸有效地维持了上皮抗性并能够降低炎性病症导致的上皮通透性的提高。另外,靶向粘膜炎性反应可以减少炎症介质对肠道屏障机能和上皮的吸收能力的有害作用。因此提供了一种适用于改善肠道屏障完整性的组合物,该组合物除了包括初乳之外还包括EPA,并优选地还包括GLA和DHA。
基于该生物化学途径,可以假定其他的脂肪酸组合物也有作用。因此,还提供了包括一种或多种PUFA或其混合物(脂肪混合物)的组合物。例如,可以使用一种包括任意的EPA、二十二碳六烯酸(DHA,C22:6n-3)、双同γ-亚麻酸(DGLA,C20:3n-6)、十八碳四烯酸(STA,C18:4n-3)、α亚麻酸(ALA,C18:3n-3)、二十二碳五烯酸(DPA,C22:5n-3)、二十四碳四烯酸(ETE,C20:4n-3)和/或花生四烯酸(ARA,n-6)的混合物的脂肪混合物。特别地,可以使用包含EPA和任何的DHA、DGLA、STA、ALA、DPA、ETE和/或ARA的混合物的脂肪混合物。
在一个实施方案中,使用的包含n-3和/或n-6脂肪酸的脂肪混合物占据至少约25en%、优选至少约30en%、更优选至少约35en%(en%是能量百分比的缩写,表示每种成分占制剂的总卡价(caloric value)的相对量)。使用了一种适合的相对高日剂量的多不饱和脂肪酸。优选的日剂量为至少1克PUFA、优选1-25克PUFA、更优选2-15克PUFA,并且最优选3-10克PUFA。
最佳的脂肪混合物优选地含有的n-3/n-6脂肪酸比值在1-3之间。甚至更优选该比值在1.5-2.7之间,因为这可以使所述包括该脂肪混合物的产物具有最佳的稳定性。此外,n-3脂肪酸占脂肪混合物的总脂肪酸量的重量百分比为15-50%,最优选地占20-50wt%,并且n-6脂肪酸占脂肪混合物的总脂肪酸量的重量百分比为10-50%,优选地为10-40wt%,最优选地为15-35wt%。在完整产品(complete product)中存在的其他脂肪酸不应显著地影响n-3/n-6的脂肪酸比。完整产品中n-3/n-6的比值应保持在1-3之间,并且优选在1.5-2.7之间。因此,一种适合的最佳的脂肪混合物可以包括40wt%-60wt%的琉璃苣油和40%-60%的鱼油。
优选的日用量,或者说日剂量,为至少0.15克的EPA。优选0.15-5克EPA。在本发明的这些包括DHA和/或GLA的实施方案中,使用了0.10-4.0克的DHA和0.05-2.5克的GLA。优选地,特别是在那些除EPA外还使用了DHA和/或GLA的情况下,使用了0.5-2.5克的EPA、0.3-2.0克的DHA和0.25-1.25克的GLA。最优选的量是0.75-1.5克的EPA、0.5-1.2克的DHA和0.37-1.0克的GLA。在一个实施方案中,所述营养组合物的日剂量包括0.15-5g的EPA和0.05-2.5g的GLA。
为了不损害产物的稳定性和口味(稳定性和口味可能与良好的顺应性相关),脂肪酸和初乳的比例维持在某个范围内很重要。该产品优选地相对于每克初乳蛋白含有0.01-0.30克的EPA,和如果存在的话,相对于每克初乳蛋白含有0.006-0.25克的DHA和0.003-0.17克的GLA。一个优选的实施方案是一种包含初乳和含EPA的脂肪混合物的组合物,并且EPA存在的范围是总脂肪混合物的10-40wt%。更优选地,该组合物进一步包括占总脂肪混合物1-25wt%的DHA,或该脂肪混合物进一步包括占总脂肪混合物的1-15wt%的GLA。更优选地,该脂肪混合物进一步包括占总脂肪混合物的1-25wt%的DHA和1-15wt%的GLA。
半胱氨酸和半胱氨酸源
令人惊奇地,本发明人还发现NAC形式的额外的半胱氨酸或富含半胱氨酸的蛋白质物质可以进一步改善患有肠道炎症的HIV患者的肠道屏障机能。因此,在另外一个实施方案中,本发明提供了添加半胱氨酸源的营养组合物,所述组合物可以进一步改善肠道屏障的完整性。
除上述的一种或多种成份之外,所提供的组合物任选地进一步包含合适量的半胱氨酸和/或半胱氨酸源。本文中的短语“半胱氨酸源”是指所有包含任一形式的可生物利用的半胱氨酸的化合物,并且可被换算为存在于化合物中的半胱氨酸的量或来源于消化后体内化合物的半胱氨酸的量,以摩尔表示。在肠道发炎过程中,发明人发现通过将半胱氨酸、半胱氨酸源或者二者同时添加至包括脂肪混合物和初乳的营养组合物中,可以改善肠道功能。
下文中“半胱氨酸等价物”是指半胱氨酸本身的量或者存在于半胱氨酸源中的半胱氨酸的量。例如,100mg NAC(N-乙酰半胱氨酸;MW=163.2)等价于74mg的半胱氨酸(MW121.15)。类似地,这样的换算可以被应用于蛋白质或肽。当肽(MW=X道尔顿)包含3个半胱氨酸氨基酸(3Y道尔顿)时,那么100mg这种肽等价于100×3Y/Xmg的半胱氨酸。因此100mg的这种肽是300Y/Xmg的半胱氨酸等价物。
例如,根据本发明的合适的半胱氨酸源是变性蛋白和/或非变性蛋白如乳蛋白,例如乳清蛋白(如α-乳清蛋白)或清蛋白和β-乳球蛋白或卵蛋白。这些蛋白富含半胱氨酸并且因此特别适用。植物蛋白,例如豌豆、马铃薯、大豆和水稻也可以被用来提供半胱氨酸。而且,可以使用这些蛋白源的水解产物或富集了富含半胱氨酸的蛋白质和肽的部分(例如如EP1201137中所述)。此外,可以使用合成的半胱氨酸等价物,例如半胱氨酸衍生物,如谷胱甘肽、半胱氨酸、半胱氨酸盐、N-乙酰半胱氨酸和/或二乙酰半胱氨酸。在一个实施方案中,本发明组合物包括半胱氨酸,其中所述半胱氨酸源选自N-乙酰半胱氨酸、乳清、卵蛋白,或它们的组合。
HIV感染的目标患者适合给药的日剂量为至少约100mg的半胱氨酸等价物,优选每天至少约200、400或600mg的半胱氨酸等价物,更优选每天至少约1000mg的半胱氨酸等价物。应当理解的是,日剂量可以细分为在一天内数次服用的2个、3个或者更多的剂量单位。
在另外一个实施方案中,根据本发明的组合物任选地进一步包括一种或多种化合物,所述化合物能够增强谷胱甘肽的全身和/或组织水平。其中已经发现硫辛酸、丙酮酸盐、草酰乙酸盐、草酰天冬氨酸都能刺激谷胱甘肽的水平。除半胱氨酸之外还可以使用这些刺激谷胱甘肽水平的化合物,也可以使用这些化合物来替代半胱氨酸。
营养组合物
本发明的营养组合物对携带HIV的患者特别有益处。该营养组合物可以有各种不同的能量密度,但是因为患有肠道功能障碍的HIV患者不会有很好的食欲,所以最好以小体积来提供日剂量的所有成分。因此一个优选的实施方案是一种营养棒,其中所有成分被以高密度包装于小体积中。此外,把成分加工成棒状的另一个优点是可以改善该组合物的口感和稳定性。在产品被做成棒状的情况下,优选地,每天给药的单次剂量是最大为100g的棒剂,但是较小棒剂的多次剂量也可行的,优选地不超过每天约100g的最大量。
另一个优选的实施方案是一种液体组合物,其中所述成分以这样一种方式提供:仅提供必须的较小体积且保证了所述成分的口味和稳定性。优选地,使用每日剂量不超过250ml或者甚至更优选的每日剂量不超过150ml的的液体组合物来给予本发明的组合物。
这样一种压缩营养产品的优点是:当HIV患者缺乏足够食欲的时候,小体积会提高对于该产品的顺应性和忠实性。当严重缺乏食欲的时候,该产品也可以通过喂食管方法给予,比如夜间喂食。管饲的粘性应该在1-100N.s/m2的范围内,优选1.2-30N.s/m2并且最优选1.5-20N.s/m2,20℃下的剪切率为100s-1。
一种完全营养处方能够对缺乏足够营养支持的HIV患者特别有益处,所述HIV患者需要额外的常量营养物如蛋白质、脂肪和碳水化合物,以及微量营养物例如维生素和矿物质。因此一个优选的实施方案包括高营养值的蛋白质、脂肪、碳水化合物、矿物质和维生素,其中所述维生素和矿物质需要具有如特殊医用食品(Food for SpecialMedical Purposes,FSMP)规则所要求的足够量。本发明组合物的一个优选的实施方案包含15-50en%的脂质、25-60en%的初乳蛋白、15-45en%的碳水化合物和半胱氨酸或半胱氨酸源,所述半胱氨酸源选自NAC、乳清、初乳、卵蛋白,或它们的组合。
本发明的另外一个方面是一种营养食物疗法,例如用于进一步提高亲和性(pleasantness)(例如产品的口感和顺应性)的固体(干)产品和液体产品的组合。该营养食物疗法包括给予一种包含初乳和其他成分并优选地包括NAC的棒剂,以及给予一种液体产品。所述液体产品包含能够经受液体处理步骤(例如灭菌和巴斯德灭菌)的成分,如根据本发明的脂肪混合物、纤维等。因此本发明的一个方面涉及到一个营养试剂盒,其组件包括至少一种固体组合物a)和至少一种液体组合物b),其中固体组合物a)包含初乳并优选地包括NAC,且组分b)包含一种脂肪混合物,所述脂肪混合物包含10-40wt%EPA、1-25wt%DHA和1-15wt%GLA。
腹泻是在许多食用液体食物的HIV患者中出现的一个主要问题。已经发现通过以干营养组合物或液体营养组合物的方式给予本发明的初乳组合物能够减轻粪便的问题,所述液体营养组合物的重量克分子渗透压浓度为50-500mOsm/kg,更优选为100和400mOsm/kg。
按上述观点,该营养组合物优选地不应含有过量的热量。因此,该营养组合物含有的热量优选地不超过500千卡/日剂量,更优选地为200-400千卡/日剂量,并且更优选地为250-350千卡/日剂量。
在本说明书及其权利要求中,动词“包括”及其变化形式使用其非限制性含义,意为包括该词之后接着的条目,但是并不排出没有特别说明的条目。另外,“一”或“一种”指的要素并不排除存在超过一种要素的可能性,除非文中清楚地要求有且仅有一种该要素。因此“一”或“一种”通常指“至少一种”。
实施例
实施例1.用于治疗HIV患者的肠道功能障碍的液体营养组合物
原料 g/100ml
琉璃苣油 2.0
EPA-DHA油 3.0
初乳 10.0(7.5g蛋白)
麦芽糊精 20.0
日剂量为100-300ml,优选为200ml。
实施例2.用于HIV患者的粉状营养组合物
原料 g/天 g/100g
初乳 20.00 26.27
NAC 1.2 1.55
琉璃苣油 4.00 5.25
EPA-DHA油 6.00 7.88
α-乳清蛋白 34.03 44.69
麦芽糊精DE47 7.00 9.19
麦芽糊精 5.00 6.57
SSL(乳化剂) 0.11 0.15
维生素/矿物质混合物 根据FSMP规则
每天 每100g
千卡 En% 千卡
能量蛋白 185 56.0 185
能量碳水化合物 56 17.0 86
能量脂肪 89 27.0 100
合计 330 100 371
实施例3.用于提高顺应性的液体和固体产品的营养食物疗法
一种营养试剂盒,其组件包括100ml的液体组合物和100g的固体或非水性组合物,所述液体组合物包括2.0g琉璃苣油和3g EPA/DHA油;所述固体或非水性组合物包含20克的初乳和1.2克NAC,在室温下的水活度小于0.7。
实施例4.用于HIV患者的营养组合物的日剂量
原材料 | g/天 | 活性成份 | 克 |
蛋白质牛初乳粉NACMPC总蛋白质 | 16.91.81.520.2 | IgG(初乳)N-乙酰-L-半胱氨酸乳蛋白质浓缩物 | 4.01.81.5 |
脂肪混合物鱼油琉璃苣油总脂肪 | 5.21.36.5 | EPA+DHAGLA | 2.00.5 |
膳食纤维/碳水化合物GOS糖浆菊粉HP果胶水解物果糖糖浆丙三醇总纤维和CHO | 15.00.88.817.54.546.6 | 半乳糖寡糖果糖寡糖果胶 | 6.750.757.5 |
Claims (14)
1.一种特别适合于HIV患者的营养组合物,包含初乳和含有EPA的脂肪混合物。
2.根据权利要求1的营养组合物,其中所述脂肪混合物包括10-40wt%之间的EPA。
3.根据权利要求1或2的营养组合物,其中所述脂肪混合物还包含1-25wt%的DHA。
4.根据权利要求1或2或3的营养组合物,其中所述脂肪混合物还包含1-15wt%的GLA。
5.根据权利要求1-4任一项的营养组合物,其中所述脂肪混合物的n-3/n-6脂肪酸比值在1-3之间,并且在脂肪混合物的总脂肪酸含量中,n-3脂肪酸的重量百分比为15-50%,n-6脂肪酸的重量百分比为10-50%。
6.根据权利要求1-5任一项的营养组合物,其中所述组合物还包含半胱氨酸和/或半胱氨酸源,所述组合物的日剂量中至少提供100mg半胱氨酸等价物。
7.根据权利要求6的营养组合物,其中所述半胱氨酸源是N-乙酰半胱氨酸、乳清、卵蛋白或它们的组合。
8.根据权利要求1-7任一项的营养组合物,其中所述初乳可以被哺乳动物乳制品提取物部分或完全的替代,所述提取物包含的抗体和生长因子的量至少等于或高于从分娩后1-5天、优选分娩后1-3天的牛获得的新鲜初乳中抗体和生长因子的量。
9.根据权利要求1-8任一项的营养组合物,所述组合物包含15-50en%的脂质、25-65en%的初乳蛋白、15-45en%的碳水化合物和半胱氨酸或半胱氨酸源,所述半胱氨酸源选自NAC、乳清、初乳、卵蛋白或它们的组合。
10.初乳和含EPA的脂肪混合物用于制备一种营养组合物的用途,所述营养组合物用于预防和/或HIV患者的肠道功能障碍。
11.根据权利要求10的用途,其中所述营养组合物的日剂量包括5-50克的初乳蛋白。
12.根据权利要求10或11的用途,其中所述营养组合物的日剂量包括至少0.15g的EPA。
13.根据权利要求10-12任一项的用途,其中所述营养组合物的日剂量包含0.15-5g的EPA和0.05-2.5g的GLA。
14.营养试剂盒,其组件包括至少一种固体组合物a)和至少一种液体组合物b),其中组合物a)包含初乳并优选地包括NAC,并且组合物b)包含一种脂肪混合物,所述脂肪混合物包含10-40wt%的EPA、1-25wt%的DHA和1-15wt%的GLA。
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2005
- 2005-04-21 EP EP05103257A patent/EP1723951A1/en not_active Withdrawn
- 2005-12-16 AT AT05816351T patent/ATE524189T1/de not_active IP Right Cessation
- 2005-12-16 CA CA002605414A patent/CA2605414A1/en not_active Abandoned
- 2005-12-16 AU AU2005330749A patent/AU2005330749B2/en not_active Ceased
- 2005-12-16 EP EP05816351A patent/EP1890707B1/en not_active Revoked
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- 2005-12-16 CN CNA2005800500942A patent/CN101198337A/zh active Pending
- 2005-12-16 JP JP2008507571A patent/JP2008536914A/ja active Pending
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- 2006-04-19 PT PT06733070T patent/PT1871181E/pt unknown
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- 2006-04-19 SI SI200631456T patent/SI2241196T1/sl unknown
- 2006-04-19 EP EP10165389.7A patent/EP2241196B2/en active Active
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- 2006-04-19 BR BRPI0610786A patent/BRPI0610786B8/pt not_active IP Right Cessation
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