CN104427887A - 包含RRR-α生育酚和多不饱和脂肪酸的营养组合物 - Google Patents
包含RRR-α生育酚和多不饱和脂肪酸的营养组合物 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
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Abstract
一般地公开了营养配方,且具体地公开了婴儿配方,其包含RRR-α生育酚、LC-PUFA和任选维生素C的组合。所述组合在个体、特别是婴儿中增强脑发育并改善认知表现。
Description
相关申请的交叉引用
本发明在此要求享有2012年3月14日提交的临时专利申请序列号61/610,799的权益,其公开内容以其整体通过引用并入本文。
公开领域
本公开涉及包含RRR-α生育酚的营养组合物,特别是婴儿配方。更具体地,本公开涉及包含RRR-α生育酚、长链多不饱和脂肪酸(LC-PUFA)和维生素C的营养组合物,以及在个体、特别是婴儿中施用所述组合物用于增强脑发育和/或改善认知表现的方法。
公开背景
婴儿配方今天通常用来在生命早期为早产儿和足月儿提供营养的补充或唯一来源。这些配方通常含有蛋白质、碳水化合物、脂肪、维生素、矿物质和其它营养素,并且可作为粉末、即食型液体和液体浓缩物市售。由于并非所有婴儿都可以接受人乳,因此许多婴儿配方提供了人乳的优质替代品。
除了上述营养素以外,长链多不饱和脂肪酸(LC-PUFA)包括花生四烯酸(ARA)和二十二碳六烯酸(DHA)、和生育酚包括RRR-α生育酚,存在于许多婴儿配方中。ARA和DHA,连同其它脂肪酸,通常被认为支持婴儿中的脑和视力发育,以及提供其它益处,而生育酚可以提供抗氧化剂益处用于稳定细胞膜中的不饱和脂质以抵御自身氧化作用,并且清除由氧化酶的正常活性通过脂质过氧化产生的自由基。
婴儿配方中包含的LC-PUFA可能易受氧化和降解的破坏。在一些情况下,高水平的DHA和/或ARA可导致脂质过氧化物的生成增加,在RRR-α生育酚可被肠道吸收之前,所述脂质过氧化物可以降解RRR-α生育酚。此外,黄嘌呤氧化酶(xanthin oxidase,XO)与肠中的AMP反应以产生过氧化氢,所述过氧化氢可以帮助婴儿防止细菌通过接合点(junction point)。然而,新生婴儿的抗氧化酶并没有充分发展。作为结果,来自XO的过氧化氢也可氧化脂质,诸如LC-PUFA,导致RRR-α生育酚的降解。为了对抗这种不想要的作用,婴儿配方中可以包含一种或多种抗氧化剂,以提供一些保护而免于LC-PUFA的氧化和降解。
本领域中存在对于可以为婴儿提供范围广泛的营养素同时在延长的时间周期上保持稳定性的稳定的营养配方包括婴儿配方的持续需求。
公开概述
本公开涉及包含RRR-α生育酚、DHA、ARA和维生素C的组合的营养组合物,特别是婴儿配方。所述组合物可以改善婴儿中的中枢神经系统的成熟,这由RRR-α生育酚添加(accretion)刺激脑中胆固醇产生和所产生的胆固醇刺激的神经元髓鞘化而导致。在许多实施方案中,所述营养组合物进一步包含蛋白质、脂肪和碳水化合物来源。在一些实施方案中,使用营养组合物的方法包括改善婴儿的中枢神经系统成熟和认知的方法。
一些实施方案涉及包含至少7 mg/L的 RRR-α生育酚、至少60 mg/L的二十二碳六烯酸、至少110 mg/L的花生四烯酸和至少130
mg/L的维生素C的营养组合物。
一些实施方案涉及用于增强婴儿中的脑发育的方法。所述方法包括将包含至少7 mg/L的 RRR-α生育酚、至少60
mg/L的二十二碳六烯酸、至少110 mg/L的花生四烯酸和至少130
mg/L的维生素C的婴儿配方施用于婴儿。
一些实施方案涉及用于改善婴儿中的认知表现的方法。所述方法包括将包含至少7 mg/L的 RRR-α生育酚、至少60
mg/L的二十二碳六烯酸、至少110 mg/L的花生四烯酸和至少130
mg/L的维生素C的婴儿配方施用于婴儿。
一些实施方案涉及包含至少7 mg/L的 RRR-α生育酚、至少60 mg/L的二十二碳六烯酸和至少110 mg/L的花生四烯酸的营养组合物。
现已发现,包含RRR-α生育酚、DHA和ARA的特定组合和量的营养组合物,诸如婴儿配方,由于RRR-α生育酚的脑添加的增强而为婴儿提供了改善的中枢神经系统成熟和认知发育、发挥功能和/或表现。进一步,将维生素C添加至RRR-α生育酚、DHA和ARA的组合提供了免于DHA和ARA的氧化的保护,从而进一步保护RRR-α生育酚免于降解,并允许RRR-α生育酚、DHA和ARA更好地被个体的肠道吸收。
因此,本公开的营养组合物和方法提供了可替代的治疗或营养干预选项,其可有助于个体、特别是婴儿、幼儿和儿童中的脑发育的增强、增强的中枢神经系统发育以及认知表现的改善。
公开详述
本文公开的组合物和方法通常涉及包含RRR-α生育酚、DHA、ARA和维生素C的组合的营养组合物,特别是婴儿配方。通过RRR-α生育酚在脑中的添加,这些组合物能够增强婴儿脑发育,增强婴儿中枢神经系统发育,和改善婴儿的总体认知表现。
至关重要的是,在生命的早期,婴儿接受足够的营养,以便提供身体和心理上足够的成熟,特别是在脑和中枢神经系统中。营养不足可导致在许多个体中可终身的许多健康问题。脑和中枢神经系统成熟是对于婴儿关键的发育区域。通过来自本文所述的营养组合物的RRR-α生育酚的脑添加,婴儿的中枢神经系统成熟可通过改善的神经元髓鞘化而得到增强和改善。此外,RRR-α生育酚的脑添加刺激脑谷氨酸合成,其增强并刺激新生神经元延长和分支,这导致在神经元之间建立间隙连接。因此,如本文所述的营养组合物的使用提供必要的营养素,以使婴儿发育成熟的中枢神经系统和改善的认知。
下文详细地描述各个实施方案的这些和其它要素或特征。
术语“蒸煮”和“蒸煮灭菌的”在本文中可互换使用,且除非另外规定,是指如下常用操作:用营养液(诸如液体婴儿配方)填充容器,最通常为金属罐或其它类似包装,然后使该填充液体的包装进行必要的热灭菌步骤,以形成经蒸煮灭菌的营养液产品。
术语“无菌的”和“无菌灭菌的”在本文中可互换使用,且除非另外规定,是指不依靠上述蒸煮包装步骤来制造包装产品,其中营养液和包装在填充之前分别进行灭菌,然后在灭菌或无菌处理条件下组合以形成经灭菌的、无菌包装的营养液产品。
除非另外规定,如本文中所使用,术语“营养组合物”、“营养产品”和“营养配方”,可以互换用于指包含蛋白质、脂肪和碳水化合物中的至少一种并适用于口服施用于人的营养液和营养粉。营养组合物可以进一步包含维生素、矿物质和其它成分,并代表营养的唯一的、主要的或补充的来源。营养组合物包括婴儿配方。
除非另外规定,如本文中所使用,术语“营养液”是指呈即饮型液体形式、浓缩形式的营养产品,和通过在使用之前重构本文所述的营养粉所制备的营养液。
除非另外规定,如本文中所使用,术语“营养粉”是指呈可流动或可舀取形式的营养产品,其可在食用之前用水或另一种含水液体重构且包括喷雾干燥的和干混/干掺的粉末。
除非另外规定,如本文中所使用,术语“脂肪”、“脂质”和“油”可互换用于指来源于植物或动物或从植物或动物加工的脂质物质。这些术语也包括合成脂质物质,只要此类合成物质适于口服施用于人。
除非另外规定,如本文中所使用,术语“认知表现”是指脑的学习、思考和记忆功能(即,记忆获取、记忆保留和记忆回想)。因此,除非另外规定,如本文中所使用,术语“改善认知表现”是指改善婴儿的学习、思考和/或记忆(记忆获取、记忆保留和记忆回想)功能。
除非另外规定,如本文中所使用,所有百分数、份数和比例均以总产品的重量计。除非另外规定,所有此类重量在其涉及所列成分时均基于活性水平且因此不包括可包括于市售物质中的溶剂或副产物。
除非另外规定或提及的上下文清楚地暗示为相反,所有对本公开的单数特征或限制的提及均应包括相应的复数特征或限制,且反之亦然。
除非另外规定或提及组合的上下文清楚地暗示为相反,如本文中所使用的方法或处理步骤的所有组合均可以以任何顺序进行。
本公开的营养组合物的多种实施方案也可以基本上无本文所述的任何成分或特征,条件是其余配方仍然含有所有需要的本文所述的成分或特征。在这种上下文中,且除非另外规定,术语“基本上无”意指选择的组合物含有小于功能量的任选成分,典型地小于1重量%,包括小于0.5重量%,包括小于0.1重量%,且还包括0重量%的此类任选或选择的基本成分。
营养组合物可包含下列,由下列组成,或基本上由下列组成:如本文所述的产品的要素以及本文所述或另外用于营养产品应用中的任何其它或任选的要素。
产品形式
在一些实施方案中,本公开的营养组合物包含RRR-α生育酚、LC-PUFA和维生素C的组合,并且可以以任何已知的或其它合适的口服产品形式进行配制和施用。任何固体、半固体、液体、半液体或粉末形式(包括其组合或变化)适于本文使用,条件是此类形式允许安全和有效地将如本文又定义的基本成分口服递送至个体。
适合于本文公开的产品和方法使用的产品形式的具体非限制性实例包括,例如,液体和粉末早产儿配方、液体和粉末足月儿配方、液体和粉末幼儿配方、和液体和粉末基本和半基本配方。成人营养配方也在本公开的范围之内。
本公开的营养组合物优选地配制为膳食产品形式,其在本文中定义为呈这样的产品形式的包含本公开成分的那些实施方案,所述产品形式还含有脂肪、蛋白质和碳水化合物中的至少一种。组合物可以用足够种类和量的营养素配制以提供营养的唯一、主要或补充来源,或提供诸如用于患有特定疾病或状况的婴儿的或具有目标营养益处的专用营养产品。
营养液
营养液包括浓缩和即食型营养液两者。这些营养液最通常被配制为悬浮液、乳状液或澄清或基本澄清的液体。
适合使用的营养乳状液可以是包含蛋白质、脂肪和碳水化合物的含水乳状液。这些乳状液通常在约1℃至约25℃下为可流动或可饮用液体且通常呈水包油、油包水或复合含水乳状液(complex
aqueous emulsion)形式,尽管此类乳状液最通常呈具有连续水相和不连续油相的水包油乳状液形式。
营养液可为且通常为储存稳定的。营养液通常含有营养液的高至95重量%的水,包括约50重量%至约95重量%,也包括约60重量%至约90重量%,且也包括约70重量%至约85重量%的水。营养液可具有多种产品密度,但最通常具有密度大于1.03 g/mL,包括大于1.04
g/mL,包括大于1.055 g/mL,包括约1.06
g/ml至约1.12 g/mL,且也包括约1.085
g/ml至约1.10 g/mL。
营养液可具有约3.5至约8的pH范围,但最有利地在约4.5至约7.5的范围内,包括约5.5至约7.3,包括约6.2至约7.2。
尽管营养液的食用份量(serving size)可根据许多变量而变化,但典型食用份量通常为至少2 mL,或甚至至少5 mL,或甚至至少10 mL,或甚至至少25 mL,包括2 mL至约300 mL的范围,包括约100 mL至约300 mL的范围,约4 mL至约250 mL的范围,约150 mL至约250 mL的范围,约10 mL至约240 mL的范围,和约190 mL至约240 mL的范围。
营养粉
营养粉呈可流动或基本上可流动的微粒组合物或至少微粒组合物的形式。特别适合的营养粉形式包括喷雾干燥、聚结或干掺的粉末组合物或其组合,或通过其它合适方法制备的粉末。所述组合物可容易地用勺或类似其它装置舀取和测量,其中所述组合物可容易地用适合的含水液体(通常为水)重构,以形成供立即口服或肠道使用的营养液(诸如婴儿配方)。在此情形下,“立即”使用通常意指在约48小时内,最通常在约24小时内,优选在重构后立刻或重构20分钟内。
RRR-
α生育酚
本公开的营养组合物包括RRR-α生育酚。如本文中所使用,术语“RRR-α生育酚”是指营养组合物包括婴儿配方中存在的RRR-α生育酚和RRR-α生育酚乙酸酯的外源来源和内在来源两者。内在来源包括在组分中内在存在的RRR-α生育酚,所述组分存在于营养组合物中,并且可包括,例如,各种油和脂肪。RRR-α生育酚的外源来源包括不作为另一种组分的部分被添加至营养组合物的RRR-α生育酚。
已经发现,RRR-α生育酚的脑添加增强中枢神经系统成熟和认知;即,RRR-α生育酚在人婴儿的脑中的存在增强婴儿的中枢神经系统的成熟和认知发育。升高水平的RRR-α生育酚在脑中的存在可增加脑中胆固醇的产生,这导致增加的神经元髓鞘化。此外,RRR-α生育酚的脑添加刺激脑中谷氨酸的产生,这可导致神经元延长和分支,其导致在神经元之间建立间隙连接。这种间隙通信可以显著增加神经元之间的通信速度,并使脑在更短时间内处理更多的数据。
生育酚,一般称为维生素E,以四种形式α、β、γ和δ可得,它们在苯并二氢吡喃环上甲基的数目和位置上不同(参见表1)。进一步,生育酚可根据植基尾部的手性以许多立体异构形式存在。在α生育酚中,RRR-α生育酚(也称为“天然维生素E”),具有最大的生物活性,并且据报道是脑中α生育酚的主要形式。RRR-α生育酚是单一立体异构体,而合成的维生素E(全外消旋-α生育酚或生育酚乙酸酯)是八种异构体的等摩尔混合物,其中只有一种是RRR-α生育酚。α生育酚的主要形式是RRRα生育酚(基于动物研究)的事实强烈表明,其它七种手性异构体必须被脑以较低速率吸收或以较快速率氧化。胆固醇是髓磷脂的主要组分,并且可能经刺激的胆固醇合成可刺激新生婴儿神经元髓鞘化。已经显示谷氨酸刺激神经突向外生长和分支;神经突生长和分支允许神经元细胞与多个神经元建立间隙连接; RRRα生育酚与谷氨酸和胆固醇相关的发现表明,RRRα生育酚在新生婴儿中枢神经系统成熟中发挥关键作用。
RRR-α生育酚以以下浓度存在于营养组合物中:婴儿配方的至少7
mg/L,包括至少8 mg/L,包括至少9
mg/L,包括至少10 mg/L,包括至少15
mg/L,包括至少18 mg/L,包括至少20
mg/L,包括至少7 mg/L至约100
mg/L,包括至少7 mg/L至约50
mg/L,且包括约20 mg/L至约40
mg/L。RRR-α生育酚的总量包括如上所指出的RRR-α生育酚的外源和内在的量两者。
在一些实施方案中,除了RRR-α生育酚,所述营养组合物包含另一种额外生育酚,特别是γ生育酚。γ生育酚已被用于食品应用中作为抗氧化剂,由此防止食品和饮料由于敏感组分诸如一些脂肪的氧化而导致的变质。
然而,现已发现γ生育酚与磷脂负相关。因此,当存在时,γ生育酚在婴儿配方中以营养组合物的小于7
mg/L,包括小于5 mg/L,包括0
mg/L至3 mg/L,包括约1
mg/L至3 mg/L的浓度存在。
长链多不饱和脂肪酸
(LC-PUFA)
除了RRR-α生育酚,本公开的营养组合物包含LC-PUFA。营养组合物中包含LC-PUFA,以便在个体中、特别是婴儿中提供营养支持和益处,以及支持脑发育。在一些实施方案中,所述营养组合物包含LC-PUFA与RRR-α生育酚的组合。除了RRR-α生育酚,特别适合于营养组合物中使用的是花生四烯酸(ARA)和二十二碳六烯酸(DHA)的组合。
DHA是n-3 LC-PUFA,并且在脑和视网膜中富含,占脑中LC-PUFA的40%和视网膜中LC-PUFA的60%。ARA是存在于机体细胞膜的磷脂特别是磷脂酰乙醇胺、磷脂酰胆碱和和磷脂酰肌醇酯(phosphatidylinositide)中的n-6 LC-PUFA,并且在脑、肌肉和肝中富集。
LC-PUFA可作为游离脂肪酸、以甘油三酯形式、以甘油二酯形式、以甘油单酯形式、以磷脂形式或作为上述中一种或多种的混合物,优选以甘油三酯形式提供。
在一些实施方案中,营养组合物包含以下浓度的DHA:至少60
mg/L,包括至少70 mg/L,包括至少80
mg/L,包括至少90 mg/L,包括至少100
mg/L,包括至少150 mg/L,包括至少200
mg/L,且包括60 mg/L至约1000
mg/L,且包括约100 mg/L至约500
mg/L,且包括以下浓度的ARA:至少110
mg/L,包括至少120 mg/L,包括至少130
mg/L,包括至少140 mg/L,包括至少150
mg/L,包括至少200 mg/L,且包括110
mg/L至约1000 mg/L,且还包括约110
mg/L至约500 mg/L。
在一些实施方案中,所述营养组合物包含RRR-α生育酚、DHA和ARA的组合,从而使得DHA与RRR-α生育酚的重量比范围为约5:1至约15:1,期望地约7.5:1至约10:1,并且ARA与RRR-α生育酚的重量比范围为约12:1至约24:1,期望地约12:1至约18:1。
维生素
C
除了RRR-α生育酚和LC-PUFA,本公开的营养组合物进一步包含维生素C以提供氧化保护。维生素C,也称为L-抗坏血酸或L-抗坏血酸盐,可从许多水果和蔬菜来源得到。适用于口服营养产品中使用并与此类产品的基本要素和特征相容的维生素C的任何来源可以与本公开的营养组合物使用。
最近已经发现,维生素C可以螯合游离的二价铁(其已被发现降低配方喂养早产儿中的血清维生素E水平),从而防止铁充当促氧化剂。进一步,高水平的ARA和DHA可由于肠黄嘌呤氧化酶(XO)诱导的氧化生成高水平的脂质过氧化物,在RRR-α生育酚可被肠道吸收之前,所述肠黄嘌呤氧化酶(XO)也可以降解RRR-α生育酚。因此,本公开的婴儿配方中包含维生素C可以降低RRR-α生育酚的氧化降解。
本公开的营养组合物期望地包含以下浓度的维生素C:至少130 mg/L,包括至少150 mg/L,包括至少175 mg/L,包括至少200 mg/L,包括至少225 mg/L,包括至少250 mg/L,包括至少300 mg/L,且包括130 mg/L至约1000 mg/L,且包括约200 mg/L至约500 mg/L。
类胡萝卜素
在一些实施方案中,所述营养组合物额外包含类胡萝卜素,以提供额外的氧化保护,以及进一步增强婴儿的脑发育。在示例性实施方案中,所述营养组合物包含叶黄素、β-胡萝卜素、玉米黄质、番茄红素及其组合。在一些实施方案中,所述营养组合物包含叶黄素和玉米黄质中的一种或多种。
通常期望的是营养组合物包含叶黄素、番茄红素、玉米黄质、β-胡萝卜素中的至少一种以提供约0.001
µg/mL至约5 µg/mL的类胡萝卜素总量。更具体地,营养组合物包含0.001
µg/mL至5 µg/mL,包括0.001
µg/mL至0.0190 µg/mL,包括0.001 µg/mL至0.0140
µg/L的量的叶黄素,且也包括0.044 µg/mL至5 µg/mL的叶黄素。通常还期望的是,营养组合物包含0.001
µg/mL至5 µg/mL,0.001
µg/mL至0.0130 µg/mL,包括0.001 µg/mL至0.0075
µg/mL的番茄红素,且也包括0.0185 µg/L至5 µg/L的番茄红素。通常还期望的是,营养组合物包含1
µg/mL至5 µg/mL,包括0.001
µg/mL至0.025 µg/L的β-胡萝卜素,包括0.001 µg/L至0.011
µg/mL的β-胡萝卜素,且也包括0.034
µg/mL至5 µg/mL 的β-胡萝卜素。应当理解,这些量的β-胡萝卜素、叶黄素、玉米黄质和番茄红素的任何组合可包含在本公开的营养组合物中。其它类胡萝卜素可任选包含在本文所述的婴儿配方中。本文所述的婴儿配方中所包含的类胡萝卜素的任何一种或全部可来自天然来源,或经人工合成。
所选择组合中的每种类胡萝卜素都可以从用于婴儿配方中的任何已知或另外合适的材料来源获得,并且每种都可以单独、或者所有一起、或以任何组合且来自任何数量的来源(包括来源,诸如含有其它维生素或矿物质并组合如本文所述的一种或多种类胡萝卜素的多维生素预混物)提供。叶黄素、番茄红素、β-胡萝卜素或其组合的一些合适来源的非限制性实例包括LycoVit®番茄红素(购自BASF, Mount
Olive, NJ),以油、粉末或珠形式的Lyc-O-Mato®番茄提取物(购自LycoRed Corp.,
Orange, NJ),β-胡萝卜素、叶黄素或番茄红素(购自DSM Nutritional Products, Parsippany, NJ),FloraGLO®番茄红素(购自Kemin Health, Des Moines, IA),Xangold®天然叶黄素酯(购自Cognis, Cincinnati, OH),和Lucarotin®β-胡萝卜素(购自BASF, Mount Olive, N.J)。
大量营养素
除了本文描述的RRR-α生育酚、LC-PUFA和维生素C以外,本公开的营养组合物可以进一步包含一种或多种任选的大量营养素。任选的大量营养素包括蛋白质、脂质(除了LC-PUFA以外)、碳水化合物及其组合。营养组合物期望地被配制为含有所有三种大量营养素的膳食产品。
适用于本文的大量营养素包括任何蛋白质、脂质(除了LC-PUFA以外)或碳水化合物或其已知或其它适用于口服营养组合物的来源,条件是任选的大量营养素对于口服施用是安全且有效的,且另外与营养组合物中的其它成分相容。
所述营养组合物中任选的脂质(包括LC-PUFA)、碳水化合物和蛋白质的浓度或量可以变化相当大,这取决于具体产品形式(例如,棒或其它固体剂型,基于乳或大豆的液体或其它澄清饮料,可重构的粉末等)和各种其它制剂和目标膳食需求。这些任选的大量营养素最通常地在下表所描述的任何具体范围内配制。
碳水化合物
适用于营养组合物中的任选的碳水化合物可以是简单碳水化合物、复合碳水化合物、或其变化或组合。合适的碳水化合物的非限制性实例包括水解淀粉或改性淀粉或玉米淀粉、麦芽糖糊精、异麦芽酮糖、舒可慢(sucromalt)、葡萄糖聚合物、蔗糖、玉米糖浆、玉米糖浆固体、稻来源的碳水化合物、葡萄糖、果糖、乳糖、高果糖玉米糖浆、蜂蜜、糖醇(例如麦芽糖醇、赤藓糖醇、山梨糖醇)、及其组合。
适用于本文的任选的碳水化合物也包括可溶性膳食纤维,其非限制性实例包括阿拉伯胶、低聚果糖(FOS)、羧甲基纤维素钠、瓜尔胶、柑橘果胶、低甲氧基果胶和高甲氧基果胶、燕麦和大麦葡聚糖、角叉菜胶、洋车前草(psyllium)及其组合。不溶性膳食纤维也适合作为本文的碳水化合物来源,其非限制性实例包括燕麦壳纤维、豌豆壳纤维、大豆壳纤维、大豆子叶纤维、糖用甜菜纤维、纤维素、玉米糠、及其组合。
蛋白质
适用于营养组合物中的任选的蛋白质包括水解的、部分水解的或非水解的蛋白质或蛋白质来源,且可以源自任何已知的或其它合适的来源,诸如乳(例如酪蛋白、乳清)、动物(例如肉、鱼、卵白蛋白)、谷物(例如稻、玉米)、蔬菜(例如大豆、豌豆、马铃薯)或其组合。用于本文的蛋白质也可以包括已知用于营养产品中的游离氨基酸,或完全地或部分地被其代替,所述游离氨基酸的非限制性实例包括L-色氨酸、L-谷氨酰胺、L-酪氨酸、L-甲硫氨酸、L-半胱氨酸、牛磺酸、L-精氨酸、L-肉碱、及其组合。
脂质
除了本文所述的LC-PUFA以外,适用于营养组合物中的任选的脂质,任选包括椰子油、分馏椰子油、大豆油、玉米油、橄榄油、红花油、高油酸红花油、高GLA-红花油、MCT油(中链甘油三酯)、葵花油、高油酸葵花油、棕榈油和棕榈仁油、棕榈油精、芥花油(canola oil)、亚麻籽油、琉璃苣油、棉籽油、月见草油、黑醋栗籽油、转基因油来源、真菌油、海产油(例如金枪鱼油、沙丁鱼油)等。
任选成分
营养组合物可进一步包含其它任选的成分,其可改变配方的物理、营养、化学、享乐(hedonic)或加工特征或当用于目标群体时充当药物或其它营养组分。许多此类任选成分为已知的或另外适用于其它营养产品中且也可用于本文所述的营养组合物中,条件是此类任选的成分对于口服施用为安全和有效的且与组合物中的基本成分和其它成分相容。
此类其它任选的成分的非限制性实例包括防腐剂、抗氧化剂、缓冲剂、药物活性剂、甜味剂、着色剂、调味剂、调味增强剂、增稠剂和稳定剂、乳化剂、润滑剂及其组合。
所述营养组合物可以进一步包含一种或多种矿物质,其非限制性实例包括磷、钠、氯化物(chloride)、镁、锰、铁、铜、锌、碘、钙、钾、铬、钼、硒及其组合。
所述营养组合物还可包含一种或多种维生素(除了维生素C以外),其非限制性实例包括生物素、胆碱、肌醇、叶酸、泛酸、TPAN、胆碱、维生素A、硫胺素(维生素B1)、核黄素(维生素B2)、烟酸(维生素B3)、吡哆醇(维生素B6)、氰钴胺素(维生素B12)、维生素D、维生素E、维生素K和其各种盐、酯或其它衍生物及其组合。
制造方法
营养组合物可通过用于制备所选产品形式的任何已知或另外有效的制造技术来制备。已知用于任何给定产品形式(诸如营养液和营养粉)的许多此类技术且其可容易地由营养和配制领域的普通技术人员应用于本文所述的营养产品。
液体、基于乳或大豆的营养液,例如,可以通过首先形成含有所有制剂油、任何乳化剂、纤维和脂溶性维生素的油和纤维的掺合物来制备。其它浆料(通常为碳水化合物和两种蛋白质浆料)分别通过将碳水化合物和矿物质一起与蛋白质在水中混合进行制备。然后将浆料与油掺合物一起混合。将所得混合物均化,热处理,使用任何水溶性维生素标准化,调味,并最终将液体灭菌或无菌过滤或干燥,以产生粉末。
也可以通过本文中没有具体描述的其它已知或另外合适的技术制造本公开的营养组合物,而不背离本公开的精神和范围。因此,本实施方案在所有方面均被视为示例性而非限制性的,并且所有改变和等同方案也都在本公开的描述之内。
使用方法
本公开的方法包括口服施用包含RRR-α生育酚并组合有LC-PUFA(特别是DHA和ARA)和维生素C的营养组合物,特别是婴儿配方,以增强脑发育。由于RRR-α生育酚、DHA、和ARA各自在脑中高度浓缩,包括如本文所述RRR-α生育酚与LC-PUFA 诸如DHA和ARA的组合提供了个体特别是婴儿中的脑发育所需的重要营养素 (例如胆固醇和磷脂)。
除了增强脑发育以外,可施用营养组合物以改善婴儿中的认知表现。具体地,RRR-α生育酚、DHA、ARA和维生素C的组合可通过增强有助于学习、思考和记忆的认知功能的记忆获取、记忆保留和记忆回想来改善总体认知。
可以将如本文所述的营养组合物施用于个体,通常包括婴儿,或者,在一些实施方案中,可以将其施用于“有其需要”的特定的婴儿子集;即施用于可通过施用所述婴儿配方而明确获益的特定婴儿。例如,如果特定婴儿易患(即,具有疾病或状况的遗传倾向,具有其家族史,和/或具有其症状)神经变性疾病或其它可损害/减少总体认知或认知的具体方面的疾病和状况,则所述特定婴儿可“需要”如本文所述的婴儿配方。
所述个体期望地每天食用至少一食用份营养组合物,并且在一些实施方案中,可以每天食用两份、三份、或甚至更多食用份。每个食用份期望地作为单一、未分开的剂量来施用,尽管所述食用份还可被分成两个或更多部分或分开的食用份以便在一天内以两次或更多次服用。本公开的方法包括连续逐天施用以及定期或受限施用,尽管连续逐天施用通常是期望的。本公开的方法优选基于每日应用,其中每日施用持续维持至少3天,包括至少5天,其中至少1个月,其中包括至少6周,包括至少8周,包括至少2个月,包括至少6个月,期望地至少约18-24个月,期望地作为长期、连续、每日膳食源或补充剂。
实施例
以下实施例说明本公开的营养产品的特定实施方案和/或特征。提供所述实施例仅出于说明的目的而并不应理解为限制本公开,因为在不脱离本公开的精神和范围的情况下其许多变化是可以的。
例举的产品是根据用于制备营养液(例如,乳状液)和粉末的营养工业中众所周知的制造方法制备的营养产品。
实施例
1-5
实施例1-5说明本公开的即食型营养乳状液,其成分列于下表中。除非另外规定,所有成分量均以每1000千克批次产品的千克数列出。
实施例
6-10
实施例6-10说明本公开的即食型营养乳状液,其成分列于下表中。除非另外规定,所有成分量均以每1000千克批次产品的千克数列出。
实施例
11-15
实施例11-15说明本公开的喷雾干燥营养粉,其成分列于下表中。除非另外规定,所有成分量均以每1000千克批次产品的千克数列出。
AN =根据需要。
Claims (15)
1.营养组合物,优选婴儿配方,其包含至少7 mg/L 的RRR-α生育酚、至少60 mg/L的二十二碳六烯酸、至少110 mg/L的花生四烯酸,且优选包含至少130 mg/L的维生素C。
2.根据权利要求1的营养组合物,其进一步包含小于7 mg/L的 γ生育酚。
3.根据权利要求1和2中任一项的营养组合物,其进一步包含类胡萝卜素,优选地,其中所述类胡萝卜素选自叶黄素、玉米黄质及其组合。
4.根据前述权利要求中任一项的营养组合物,其中所述婴儿配方中二十二碳六烯酸与RRR-α生育酚的重量比为5:1至15:1,优选7.5:1至10:1。
5.根据前述权利要求中任一项的营养组合物,其中所述婴儿配方中花生四烯酸与RRR-α生育酚的重量比为12:1至24:1,优选12:1至18:1。
6.用于增强婴儿中的脑发育的方法,所述方法包括将包含至少7 mg/L的 RRR-α生育酚、至少60 mg/L的二十二碳六烯酸、至少110 mg/L的花生四烯酸和至少130 mg/L的维生素C的婴儿配方施用于婴儿。
7.根据权利要求6的方法,其中所述婴儿配方中二十二碳六烯酸与RRR-α生育酚的重量比为5:1至15:1。
8.根据权利要求6和7中任一项的方法,其中所述婴儿配方中花生四烯酸与RRR-α生育酚的重量比为12:1至24:1。
9.根据权利要求6至8中任一项的方法,其中所述婴儿配方进一步包含小于7 mg/L的 γ生育酚。
10.根据权利要求6至9中任一项的方法,其中所述婴儿配方进一步包含类胡萝卜素,所述类胡萝卜素优选选自叶黄素、玉米黄质及其组合。
11.用于改善婴儿中的认知表现的方法,所述方法包括将包含至少7 mg/L的 RRR-α生育酚、至少60 mg/L的二十二碳六烯酸、至少110 mg/L的花生四烯酸和至少130 mg/L的维生素C的婴儿配方施用于婴儿。
12.根据权利要求11的方法,其中所述婴儿配方中二十二碳六烯酸与RRR-α生育酚的重量比为5:1至15:1。
13.根据权利要求11和12中任一项的方法,其中所述婴儿配方中花生四烯酸与RRR-α生育酚的重量比为12:1至24:1。
14.根据权利要求11至13中任一项的方法,其中所述婴儿配方进一步包含小于7 mg/L的 γ生育酚。
15.根据权利要求11至14中任一项的方法,其中所述婴儿配方进一步包含类胡萝卜素,所述类胡萝卜素优选选自叶黄素、玉米黄质及其组合。
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NZ630210A (en) | 2016-05-27 |
HK1205645A1 (zh) | 2015-12-24 |
IN2014DN08200A (zh) | 2015-05-01 |
IL234553A (en) | 2017-11-30 |
PH12014502024A1 (en) | 2014-11-24 |
WO2013138157A1 (en) | 2013-09-19 |
MX2014011056A (es) | 2015-03-09 |
US20150025133A1 (en) | 2015-01-22 |
CA2867438A1 (en) | 2013-09-19 |
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