TW201625143A - 具有人乳寡醣、益生質及益生菌之兒童營養組成物 - Google Patents
具有人乳寡醣、益生質及益生菌之兒童營養組成物 Download PDFInfo
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- TW201625143A TW201625143A TW104110685A TW104110685A TW201625143A TW 201625143 A TW201625143 A TW 201625143A TW 104110685 A TW104110685 A TW 104110685A TW 104110685 A TW104110685 A TW 104110685A TW 201625143 A TW201625143 A TW 201625143A
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Abstract
本揭示內容大致關於包括半乳-寡醣(galacto-oligosaccharide)和/或聚右旋糖(polydextrose)、益生菌(諸如鼠李糖乳酸桿菌(Lactobacillus rhamnosus GG))、和人乳寡醣之益生質混合物的兒童營養組成物。更具體而言,本揭示內容關於一種營養組成物,其具有(i)蛋白質來源、(ii)脂質來源、(iii)碳水化合物來源、(iv)人乳寡醣或其前驅物、(v)聚右旋糖和/或半乳-寡醣、及(vi)益生菌。所揭示之營養組成物有利地促進腸腦軸(gut-brain axis)。
Description
本揭示內容大體上提供可用於促進個體(尤其是兒童個體)胃腸道中有益細菌的營養組成物,其中該營養組成物包括益生質組成物,其包含半乳-寡醣(galacto-oligosaccharide,GOS)和/或聚右旋糖(polydextrose,PDX)、人乳寡醣(HMO)和諸如鼠李糖乳酸桿菌(Lactobacillus rhamnosus GG(LGG))的益生菌。本揭示內容亦提供用於促進兒童個體胃腸道中有益細菌生長的方法,其包含將所揭示之營養組成物投予至個體。
人類嬰兒腸道微生物相在出生後最初的幾週內會快速地建立。據瞭解嬰兒中腸道微生物相發展會藉由在出生期間暴露至母性及環境細菌而啟動。腸道微生物相的進一步發展係受到新生嬰兒的飲食所影響。嬰兒是否餵母奶或餵配方對腸內細菌數目及組成有強烈的影響。人乳含有很多巨量及微量營養素成分,其特性及功能仍正在發現
及研究。在這些成分中,人乳寡醣被認為對於嬰兒中有益細菌的生長扮演重要的角色。在餵母奶的嬰兒中,例如雙叉桿菌(Bifidobacterium species)在腸內細菌中佔優勢,而鏈球菌(Streptococcus species)及乳酸桿菌(Lactobacillus species)則較不普遍。相較之下,餵配方嬰兒中的微生物叢(microflora)更多元,含有雙叉桿菌(Bifidobacterium species)及類桿菌(Bacteroides species)及更多的致病性微生物,諸如葡萄球菌(Staphylococcus)、大腸桿菌(Escherichia coli)及梭菌(Clostridium species)。餵母奶及餵配方嬰兒糞便中雙叉桿菌的種類變化很大。雙叉桿菌(Bifidobacterium species)通常被視為有益細菌,且已知能防止病原菌的拓植(colonization)。
腸道微生物相對於健全的腦功能也是重要的,且腸道微生物相被認為經由腸腦軸(gut-brain axis)與腦相通,且因此對腦發育及功能具有影響。更具體而言,腸道微生物相經由神經、神經內分泌、神經免疫及荷爾蒙連結與腸及中樞神經系統交互作用。腦發育及生長超過任何其他器官或身體組織的發育及生長,於懷孕26週時達到高峰,且持續快速遍及生命的首三年。此階段的次佳營養(sub-optimal nutrition)對於認知功能具有不可逆的結果。
因此,需要提供諸如嬰兒配方的營養組成物,其促進健全腸道微生物相的生長,且促進健全的腸腦軸。
此種組成物可改善嬰兒及兒童的認知發育,且因此提供終身的腦助益。本揭示內容藉由提供包含益生質、HMO及益生菌的營養組成物以解決此需求。
在一些具體實例中,本揭示內容關於包含GOS和/或PDX、HMO或其一或多種前驅物、及益生菌(諸如LGG)的營養組成物。雖然不受限於任何特定理論,PDX、GOS、HMO及益生菌包括在營養組成物(諸如嬰兒配方)中時被認為可協同作用,以促進有益腸道微生物相的生長及/或功能,因而刺激腸腦軸。因此,此種組成物可促進嬰兒及兒童的健全認知發育。更特定而言,在一些具體實例中,此所提供之該營養組成物包含:(i)蛋白質來源、(ii)脂質來源、(iii)碳水化合物來源、(iv)HMO或其前驅物、(v)包含半乳-寡醣和/或聚右旋糖的益生質、及(vi)益生菌。
可用於本組成物的HMO包括但不限於2’-岩藻糖基乳糖(2’-fucosyllactose)、3’-岩藻糖基乳糖(3’-fucosyllactose)、3’唾液乳糖(3’sialyllactose)、6’唾液乳糖、乳-N-二糖(lacto-N-biose)、乳-N-新四糖(lacto-N-neotetraose)、乳-N-四糖(lacto-N-tetraose)或彼等之任何組合。HMO的前驅物(諸如唾液酸、岩藻糖或彼等之組合)亦可包含在本組成物中。
在一些具體實例中,本揭示內容的組成物亦可
包括長鏈多不飽和脂肪酸來源(諸如二十二碳六烯酸(DHA)和/或二十碳四烯酸(ARA))、ß-聚葡萄糖(ß-glucan)來源、乳鐵蛋白或彼等之任何組合。
在某些具體實例中,本揭示內容進一步提供一種用於促進所需兒童個體胃腸道中有益微生物相的生長和/或功能的方法,包含投予該個體有效量之營養組成物,該營養組成物包含:(i)蛋白質來源、(ii)脂質來源、(iii)碳水化合物來源、(iv)人乳寡醣或其前驅物、(v)益生質、及(vi)益生菌。在某些具體實例中,該腸道微生物相包含乳酸桿菌(Lactobacillus species)、雙叉桿菌(Bifidobacterium species)、支原體(Allobaculum species)或彼等之組合。
在某些具體實例中,該促進有益腸道微生物相生長及/或功能的方法亦能促進個體的認知發育。該方法可進一步減少個體中有害腸道微生物相(諸如梭菌(Clostridium species))的生長。
應了解本揭示內容前述的一般說明及下列具體實例的詳細描述皆是為了提供用於了解所請揭示內容之性質及特徵的概觀或架構。該描述用於解釋所請標的之原理及操作。經由閱讀下列的揭示內容,本揭示內容之其他及進一步特徵及優點對於該所屬技術領域中具有通常知識者而言將是顯而易知的。
圖1描繪顯示使用亮暗偏好試驗(light:dark preference test)之相較於非受壓小鼠(HCC)之含有3’-唾液乳糖(3SL)及6’-唾液乳糖(6SL)之飲食對於受壓力小鼠(SDR)的影響之圖示。
圖2描繪顯示使用開場任務試驗(open field task test)之相較於非受壓小鼠(HCC)之含有3’-唾液乳糖(3SL)及6’-唾液乳糖(6SL)之飲食對於之受壓力小鼠(SDR)的影響之圖示。
圖3描繪進行含有3’-唾液乳糖(3SL)及6’-唾液乳糖(6SL)之飲食,且接著使用開場任務試驗之相較於非受壓小鼠(HCC)之受壓力小鼠(SDR)的代表性移動路徑。
圖4為顯示餵食六種不同飲食(對照組、2g/L 3’-SL、4g/L 3’-SL、2g/L 6’-SL、或4g/L 6’-SL;2g/L PDX+2g/L GOS;n=9)之豬的每公克胼胝體組織之唾液酸的含量圖示。
圖5為顯示餵食六種不同飲食(對照組、2g/L 3’-SL、4g/L 3’-SL、2g/L 6’-SL、或4g/L 6’-SL;2g/L PDX+2g/L GOS;n=9)之豬的每公克小腦組織之唾液酸的含量圖示。
目前將詳細做出本揭示內容之具體實例的參考內容,其一或多個實例闡述如下。各實例以說明本揭示內
容之營養組成物的方式提供,且不受限制。事實上,該所屬技術領域中具有通常知識者顯然將可對本發明所教示的內容做出多種修改及變化,而不會背離該揭示內容的範圍及精神。例如,一個具體實例所舉例或描述之部分特徵可與另一個具體實例併用,以產生又另外的具體實例。
因此,本揭示內容欲涵蓋視為落在所附申請專利範圍及其均等物範圍內之此種修改及變化。本揭示內容之其他目的、特徵及態樣皆揭示於下列的詳細描述中,或由下列的詳細描述可顯然得知。該所屬技術領域中具有通常知識者了解本討論僅為例示性具體實例的描述,且不欲作為本揭示內容較廣泛態樣的限制。
「營養組成物」是指滿足個體之至少一部份營養需求的物質或配方。本揭示內容中可交換使用之術語「營養」、「營養配方」、「腸道營養」、「營養組成物」及「營養補充品」是指液體、粉末、膠狀物、糊狀物、固體、濃縮物、懸浮物、或即用形式的腸道配方、經口配方、嬰兒配方、兒童個體配方、孩童配方、成長奶及/或成人(諸如正在泌乳或懷孕婦女)配方。在特定的具體實例中,該營養組成物係用在包括嬰兒及孩童的兒童個體。
該術語「腸道的」是指可經由或在胃腸、或消化道內。「腸道投予」包括口腔餵食、胃內餵食、穿過幽門(transpyloric)投予或任何其他投予進入消化道。
「兒童個體」包括嬰兒及孩童,並且在此是指
年齡小於13歲的人。在一些具體實例中,兒童個體是指小於8歲的人個體。在其他具體實例中,兒童個體是指年齡介於約1至約6歲或年齡介於約1至約3歲的人個體。在又另外的具體實例中,兒童個體是指年齡介於約6至約12歲的人個體。
「嬰兒」是指年齡不超過約一歲且包括從約0至約12個月嬰兒的個體。該術語嬰兒包括低出生體重嬰兒、非常低出生體重嬰兒、及早產嬰兒。「早產(preterm)」是指懷孕第37週結束前出生之嬰兒,而「足月(full term)」是指懷孕第37週結束後出生之嬰兒。
「孩童」是指年齡介於從約12月至約13歲的個體。在一些具體實例中,「孩童」是指年齡介於1至12歲的個體。在其他具體實例中,該術語「孩童(children)」或「孩童(child)」是指介於約1至約6歲、介於約1至約3歲、或介於約7至約12歲的個體。在其他具體實例中,該術語「孩童(children)」或「孩童(child)」是指任何年齡範圍介於約12個月至約13歲的個體。
「孩童營養產品」是指滿足孩童至少一部分營養需求的組成物。成長奶為孩童營養產品的實例。
「嬰兒配方」是指滿足嬰兒至少一部分營養需求的組成物。在美國,嬰兒配方的含量由描述於21C.F.R.章節100、106及107之聯邦條約所規定。這些條
約致力於定義巨量營養素、維生素、礦物質及其他成分含量以模擬人母乳的營養及其他性質。
該術語「成長奶」是指欲作為多種膳食的一部分以支持年齡介於約1至約6歲孩童的正常生長及發育之廣泛種類的營養組成物。
「建基於乳(milk-based)」是指包含自哺乳動物乳腺抽出或萃取的至少一種成分。在一些具體實例中,建基於乳的營養組成物包含衍生自馴養之有蹄類動物、反芻動物或其他哺乳動物或彼等之任何組合之乳成分。此外,在一些具體實例中,建基於乳是指包含牛酪蛋白、乳清、乳糖或彼等之任何組合物。另外,「建基於乳之營養組成物」可指包含該技術領域中已知的任何衍生自乳或建基於乳之產品的任合組成物。
「營養完整」是指可被用作為單獨的營養來源,其能供應基本上所有每日所需之維生素、礦物質及/或微量元素與蛋白質、碳水化合物、和脂質組合的量。事實上,「營養完整」描述提供支持個體的正常生長及發育所需之適量碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、視情況的必需胺基酸、維生素、礦物質和能量的營養組成物。
因此,定義上對早產嬰兒為「營養完整」的營養組成物提供早產嬰兒生長所需之品質上及數量上適量的碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、視情況的必需胺基酸、維生素、礦物質和能量。
定義上,對足月嬰兒為「營養完整」的營養組成物提供足月嬰兒生長所需之品質上及數量上適量的所有碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、視情況的必需胺基酸、維生素、礦物質和能量。
定義上,對孩童為「營養完整」的營養組成物提供孩童生長所需之品質上及數量上適量的所有碳水化合物、脂質、必需脂肪酸、蛋白質、必需胺基酸、視情況地必需胺基酸、維生素、礦物質和能量。
當應用於營養素,該術語「必需」是指任何無法由身體合成對於正常生長足量且用以維持健康的營養素,且因此必須藉由膳食補充。該術語「視情況地必需」應用於營養素是指當身體無法取得適量的前驅化合物以供內生性合成並產生營養素的條件下,營養素必須藉由膳食補充。
「營養補充品」或「補充品」是指含有營養上相應量之至少一種營養素的配方。例如,此處所述之補充品可提供給人個體(諸如泌乳中或懷孕女性)至少一種營養素。
「益生菌」是指施加至少一種有益功效於宿主健康之具有低或無致病力之微生物。益生菌的實例為LGG。
在一具體實例中,該益生菌可為存活的或非存活的。至於本文所使用之術語「存活的(viable)」是指活著的微生物。該術語「非存活的(non-viable)」或
「非存活的益生菌」是指非活著的益生菌微生物、它們的細胞成分及/或其代謝物。此種非存活的益生菌可能已被加熱殺死或以其他方式去活化,但是它們保留有利於影響宿主健康的能力。可用於本揭示內容的該益生菌可為天然產生、合成或經由生物體的基因操作所開發,無論此來源為目前已知或以後所開發。
該術語「非存活的益生菌」是指所提及益生菌之代謝活性或繁殖力被降低或摧毀的益生菌。更具體而言,「非存活的」或「非存活的益生菌」是指非活著的益生菌微生物、它們的細胞成分及/或其代謝物。此種非存活的益生菌可能已被加熱殺死或以其他方式去活化(inactivated)。然而,該「非存活的益生菌」在細胞層次上仍保留其細胞結構或其他與細胞相關的結構,例如,胞外多醣及只少一部分其生物二醇-蛋白質及DNA/RNA結構,且因此保留有利於影響宿主健康的能力。反之,該術語「存活的」是指活著的微生物。至於此處所使用之術語「非存活的」與「去活化」同義。
該術語「細胞相等」是指非存活的、非複製(non-replicating)的益生菌的量相當於存活細胞之相同數目。該術語「非複製」可了解為由相同數量之複製細菌(cfu/g)所得之非複製微生物的數量,包括去活化益生菌、DNA片段、細胞壁或細胞質化合物。換句話說,非活著、非複製生物體的量以術語cfu表示,猶如所有的微生物是活著的,無論它們是不是死的、非複製、去活化、
片段化等。
「益生質」是指藉由選擇性的地刺激在消化道中一種或有限數量之有益腸道細菌的生長及/或活性、選擇性減少腸道病源菌、或有利地影響能改善宿主健康之腸道短鏈脂肪酸概廓(profile)而有利地影響宿主之非可消化性食物成分。
「β-聚葡萄糖(β-glucan)」是指所有的β-聚葡萄糖,包括β-1,3-聚葡萄糖及β-1,3;1,6-聚葡萄糖兩者,其各自為特定類型的β-聚葡萄糖。此外,β-1,3;1,6-聚葡萄糖為β-1,3-聚葡萄糖的一種類型。因此,該術語「β-1,3-聚葡萄糖」包括β-1,3;1,6-聚葡萄糖。
除非另有指明,此處所使用之所有的百分比、份及比例皆以總配方的重量計。
本揭示內容之該營養組成物可無或實質上無任何本文所述之任意的或所選擇的成分。在此情況下,且除非另有指明,該術語「實質上無」是指該所選之組成物可含有少於任意的成分之功能性數量,通常少於0.1重量%,且亦包括0重量%之此種任意的或所選擇的成分。
所有涉及本揭示內容之單一特性或限制應包括對應的多個特性或限制,且反之亦然,除非藉由作成文獻的情況另有指明或清楚隱含相反之意。
本文所使用之方法或處理步驟之所有組合可以任何順序實施,除非藉由作成參考組合的情況另有指明或清楚隱含相反之意。
本揭示內容之組成物和方法(包括彼等之組分)可包含本文所述具體實例的必要元件及限制、由或基本上由該必要元件及限制所組成,及任何本文所述之附加或任意的成分、組分或限制或其他可用於營養組成物者。
當用於本文,該術語「約」應被解釋為是指在任何範圍內所指定的兩者數字。任何參考範圍應被視為是對該範圍內的任何子集提供支持。
本揭示內容普遍地關於包含益生質(諸如GOS、PDX或在較佳具體實例中為GOS與PDX的組合);HMO;及益生菌(諸如LGG)的兒童營養組成物,其能調節兒童個體(包括早產及足月嬰兒、幼兒及孩童)的腸腦軸。該GOS/PDX、HMO及益生菌被認為能藉由刺激有益腸道微生物相的生長及活性以互補及/或協作方式合作。腸道微生物相對於人嬰兒之正常健康腦功能及發育很重要。因此,本組成物被認為能促進健康腦發育及功能。更特別地,在一些具體實例中,本組成物藉由增加雙叉桿菌(Bifidobacterium)、乳酸桿菌(Lactobacillus)或支原體(Allobaculum species)的增殖改善腸道微生物相組成物及/或活性,同時減少諸如梭菌(Clostridium species)之有害微生物相的增生。
更特定而言,本組成物可經由腸的神經系統調
節個體之神經發育及功能,包括中樞及周邊神經兩者。雖然不受限於理論,在發育中腸腦軸的交互作用被認為能促進兒童族群的神經學發育及功能。另外的神經學助益可包
括促進視覺功能、感覺運動發展、探索和操作、個體關聯性(object relatedness)、個體識別、社會和情感的發展,健康的睡眠模式和減輕壓力。
因此,在一些具體實例中,本揭示內容提供一種營養組成物,其包含:(i)蛋白質來源、(ii)脂質來源、(iii)碳水化合物來源、(iv)人乳寡醣或其前驅物、(v)益生質,其包含GOS及/或PDX、及(vi)益生菌。
該術語「HMO」或「人乳寡醣」是泛指人母乳中之一些可為酸性或中性形式的複合碳水化合物。在某些具體實例中,該HMO是2’-岩藻糖基乳糖、3’-岩藻糖基乳糖、3’唾液乳糖、6’唾液乳糖、乳-N-二糖(lacto-N-biose)、乳-N-新四糖(lacto-N-neotetraose)、乳-N-四糖(lacto-N-tetraose)或彼等之任何組合。3’唾液乳糖、6’唾液乳糖有助於唾液酸,其為一種對腦發育及認知功能重要的營養素。HMO可由乳品分離或富集(enrich),或經由微生物發酵、酵素過程、化學合成或彼等之組合所產生。例示性的HMO前驅物包括唾液酸、岩藻糖或彼等之組合。
於母乳餵養嬰兒中HMO被認為與有益嬰兒之特定雙叉桿菌(Bifidobacterium species)的存在有關,該雙叉桿菌諸如長雙叉桿菌(B.longum)、嬰兒雙叉桿菌(B.infantis)、短雙叉桿菌(B.breve)及雙叉雙叉桿菌(B.bifidium)。因此、用於本組成物中之該HMO可提
供功能上接近人乳的嬰兒配方。此外,該HMO可與GOS/PDX及LGG協同作用,以進一步促進該腸惱軸,因而對兒童個體提供直接及終身的胃腸及神經學助益。在某些具體實例中,該HMO在本組成物中的含量介於約0.005g/100kcal至約1g/100kcal。在其他具體實例中,該HMO的含量介於約0.01g/100kcal至約0.1g/100kcal、約0.015g/100kcal至約0.05g/100kcal。
所揭示之營養組成物亦包含益生質來源,特別地為GOS及/或PDX。在一個具體實例中,至少20%之益生質包含GOS。在其他具體實例中,益生質成分包含GOS及PDX兩者。GOS及PDX的重量比為約1:9至約9:1。在其他具體實例中,GOS及PDX之比為約1:4至4:1,或約1:1。
在一些具體實例中,在營養組成物中GOS的含量可為約0.1g/100kcal至約1.0g/100kcal。在另一個具體實例中,在營養組成物中GOS的含量可為約0.1g/100kcal至約0.5g/100kcal。在一些具體實例中,在營養組成物中PDX的含量在介於約0.1g/100kcal至約0.5g/100kcal的範圍內。在其他具體實例中,PDX的含量可為約0.3g/100kcal。
在特定的具體實例中,GOS及PDX以約至少約0.2g/100kcal之總含量補充至該營養組成物中,且可為約0.2g/100kcal至約1.5g/100kcal。在一些具體實例中,該營養組成物可包含總含量約0.6至約0.8g/100kcal之
GOS及PDX。
在一些具體實例中,該營養組成物包含鼠李糖乳酸桿菌(Lactobacillus rhamnosus GG)(ATCC號碼53103)。可用於本營養組成物的其他益生菌包括(但不限於)雙叉桿菌(Bifidobacterium species),諸如長雙叉桿菌BB536(BL999,ATCC:BAA-999)及動物雙叉桿菌乳酸亞種(Bifidobacterium animalis subsp.lactis)BB-12(DSM No.10140)或任何彼等之組合。
LGG及益生質(諸如GOS及PDX)被認為能顯著地且另人驚訝地改善腦發育、認知功能、及甚至社會及情感技能。另外,施予GOS、PDX與LGG的組合能改變神經傳導物(諸如血清素、5-羥色胺酸、正腎上腺素及/或5-羥吲哚乙酸)的產生。該組成物調節神經傳導物的能力可解釋本組成物對於社會技能、焦慮及記憶功能的有益功效。
在一些具體實例中,該營養組成物包括含量從約1×104cfu/100kcal至約1.5×1010cfu/100kcal的益生菌,且更特別地為LGG。在其他具體實例中,該營養組成物包含含量從約1×106cfu/100kcal至約1×109cfu/100kcal的LGG。又在某些具體實例中,該營養組成物可包括含量從約1×107cfu/100kcal至約1×108cfu/100kcal的LGG。在一些具體實例中,LGG不包括該濃度範圍的上限,另外的益生菌可包括至所指定之上限濃度。該益生菌可為非存活的或存活的。
在一些具體實例中,藉由包括從益生菌批次培養過程之後指數生長期的培養物上清液以提供本揭示內容之該營養組成物中的益生菌功能性,如同國際公開案號WO 2013/142403所述,特此將其以整體引用方式併入本文。不希望受限於理論,但據信,該培養物上清液的活性可歸因於當在益生菌批次培養的指數(或「對數」(log))期後階段所發現被釋放至該培養物介質之組分(包括蛋白質材料、且可能包括(胞外)多醣材料)的混合物。本文所使用之該術語「培養物上清液」包括在該培養物介質中所發現之組分的混合物。該技術之人士已知該細菌之批次培養中所識別的階段。這些階段為「遲滯(lag)」、「對數(log)」(對數(logarithmic)或指數(exponential))、「靜止」及「死亡」(或對數遞減)期。在存在活著的細菌之所有的期間,該細菌由該介質代謝營養素,且分泌(施加或釋放)物質至該培養物介質中。在生長階段之指定時間點所分泌物質之組成物通常為無法預測的。
在一具體實例中,培養物上清液係藉由包含以下步驟的方法所獲得:(a)使用批次方法使諸如LGG之益生菌培養在合適的培養介質中;(b)在培養步驟之後指數生長期收穫該培養物上清液,該時期係藉由參照批次培養方法之遲滯期及靜止期之間時間的第二半部所定義;(c)任意地從該上清液移除低分子量組成,以保持分子量組成高於5-6千道爾頓(kDa);(d)從該培養物上清
液移除液體含量,以獲得該組成物。
該培養物上清液可包含從後指數期所收穫之分泌物質。該後指數期發生在中指數期(其為該指數期期間的中間時間,因此參照至該後指數期則視為該遲滯期與該靜止期之間時間的第二半部)之後的時間。特別地,本文所使用之該術語「後指數期」為參照至該LGG批次培養過程中該遲滯期與該靜止期之間時間的後四分之一部分。在一些具體實例中,該培養物上清液係在指數期期間75%至85%的時間點所收穫,且可在該指數期經過約5/6的時間所收穫。
揭示內容之營養組成物可含有包含二十二碳六烯酸之長鏈多不飽和脂肪酸(LCPUFA)來源。其他合適的LCPUFA包括(但不限於)α-亞麻油酸、γ-亞麻油酸、亞麻油酸、次亞麻油酸、二十二碳六烯酸(DHA)、二十碳五烯酸(EPA)及二十碳四烯酸(ARA)。
在一具體實例中,特別是若該營養組成物為嬰兒配方,該營養組成物以DHA及ARA兩者補充。在此具體實例中,ARA:DHA的重量比可介於約1:3及約9:1。在特定的具體實例中,ARA:DHA的比從約1:2至約4:1。
如果包括的話,DHA及/或ARA的來源可為任何該技術中已知的來源,諸如海洋石油(marine oil)、魚油、單細胞油、蛋黃脂質及腦脂質。在一些具體實例中,該DHA及ARA源自單細胞馬泰克油(Martek oil)
(DHASCO®及ARASCO®),或彼等之變體。該DHA及ARA可以是天然形式,條件是該LCPUFA來源的剩餘部分不會造成對個體任何實質有害的影響。或者,該DHA及ARA可以精煉形式使用。
在一具體實例中,DHA及ARA來源為如美國專利編號5,374,657;5,550,156;及5,397,591所教示的單細胞油類,將其揭示內容以整體引用方式併入本文。然而,本揭示內容不僅限於此種油類。
該營養組成物亦可包含ß-聚葡萄糖來源。聚葡萄糖為多醣類(特別是葡萄糖的聚合物),其為天然產生且可發現於細菌、酵母菌、真菌和植物的細胞壁中。ß-聚葡萄糖本身為葡萄糖聚合物的多種子集,其係經由ß類型糖苷鍵將葡萄糖單體鏈連接在一起形成複合物碳水化合物所製成。
β-1,3-聚葡萄糖為由例如酵母菌、蕈類、細菌、藻類或穀類所純化出之碳水化合物聚合物。(Stone BA,Clarke AE.Chemistry and Biology of(1-3)-Beta-Glucans.London:Portland Press Ltd;1993.)β-1,3-聚葡萄糖之化學結構取決於β-1,3-聚葡萄糖來源。此外,多種物理化學參數(例如溶解度、一級結構、分子量及分枝)對β-1,3-聚葡萄糖的生物活性有重要的影響。(Yadomae T.,Structure and biological activities of fungal beta-1,3-glucans.Yakugaku Zasshi.2000;120:413-431.)
β-1,3-聚葡萄糖為具或不具有β-1,6-葡萄糖側鏈
之天然產生的多醣類,其可發現於多種植物、酵母菌、真菌和細菌的細胞壁中。β-1,3;1,6-聚葡萄糖包含具有接附於(1,6)位置之側鏈的(1,3)連接子之葡萄糖單元。β-1,3;1,6-聚葡萄糖為享有結構共通性的葡萄糖聚合物之非均質群組,其包括藉由β-1,3鍵所連接之直鏈葡萄糖單元骨架與由此骨架所延伸出之β-1,6-連接葡萄糖分枝。當此為本文所描述之ß-聚葡萄糖類型的基本結構,可能存在某些變體。例如,某些酵母菌ß-聚葡萄糖具有由該β(1,6)分枝所延伸出之另外區域的β(1,3)分枝,該分枝會使其個別結構增加更多的複雜性。
衍生自麵包酵母(啤酒酵母菌(Saccharomyces cerevisiae))之ß-聚葡萄糖由連接於該1及3位置的D-葡萄糖分子鏈構成,其具有附接於該1及6位置之葡萄糖側鏈。衍生自酵母菌的ß-聚葡萄糖為具有包含穿插有β-1,6側鏈之β-1,3骨架的葡萄糖單元直鏈(長度通常為6-8個葡萄糖單元)之一般結構的不可溶纖維狀複合物糖。更具體而言,衍生自麵包酵母之ß-聚葡萄糖為聚-(1,6)-β-D-葡萄呱喃糖基-(1,3)-β-D-葡萄呱喃糖。
此外,ß-聚葡萄糖具有良好耐受性且不會產生或導致兒童個體有過多氣體、腹脹、氣脹或腹瀉。添加ß-聚葡萄糖至針對兒童個體的營養組成物(諸如嬰兒配方、成長乳或其他孩童的營養產品)會藉由增加抵抗入侵病原體的抗性而增進該個體的免疫反應,且因此維持或改善總體健康。
在特定的具體實例中,營養組成物包含每100kcal:(i)介於約1g及約7g的蛋白質來源、(ii)介於約1g及約10g的脂質來源、(iii)介於約6g及約22g的碳水化合物來源、(iv)介於約0.005g及約1g的人乳寡醣、(v)介於約0.1mg及1.0mg的半乳-寡醣、(vi)介於約0.1mg及約0.5mg的聚右旋糖、及(vii)介於約1×105cfu/100kcal至約1.5×109cfu/100kcal之鼠李糖乳酸桿菌(Lactobacillus rhamnosus GG)或約1×105當量cfu/100kcal至約1.5×109當量cfu/100kcal之鼠李糖乳酸桿菌的乾燥組成物。在一些具體實例中,該營養組成物包含從約0.015g/100kcal至約1.5g/100kcal之培養物上清液。
本揭示內容亦提供一種用於促進有需要之兒童個體胃腸道中有益微生物相生長的方法,其包含將此處所描述之有效量的任何營養組成物施予至該個體,例如一種包含PDX、GOS、HMO及諸如LGG之益生菌的營養組成物。更特定而言,本揭示內容提供一種用於促進有需要之兒童個體胃腸道中有益微生物相生長的方法,其包含將有效量的營養組成物施予至該個體,該營養組成物包含:(i)蛋白質來源、(ii)脂質來源、(iii)碳水化合物來源、(iv)人乳寡醣或其前驅物、(v)包含聚右旋糖及半乳-寡醣之益生質、及(vi)益生菌。
在某些具體實例中,將該組成物施予至該個體會刺激該個體中腸道細菌的生長,其中該腸道細菌包含乳
酸桿菌(Lactobacillus species)、雙叉桿菌(Bifidobacterium species)、支原體(Allobaculum species)或彼等之組合。在另一個具體實例中,該方法會減少該個體腸道中梭菌(Clostridium species)的生長。在又其他具體實例中,該方法增進個體的認知發育。
更具體而言,在一些具體實例中,本組成物及方法增進個體的正常心智表現、學習、記憶、認知及視覺功能。在其他具體實例中,本組成物及方法支持個體健康、正常或改善的行為、心理動作及情緒發展。還有在另外的具體實例中,本組成物及方法增進感覺運動發育、探索及操作、個體關聯性(object relatedness)、視覺敏銳度、異議認可、視覺注意力及/或其他認知處理方面。
不受限於特定的理論,多種作用機制能有助於本揭示內容之營養組成物及方法之有益胃腸上及神經學上的助益。例如,藉由腸道微生物相產物的有益組成物可影響腦及影響行為。另外,該組成物可增進下視丘-腦下垂體-腎上腺(HPA)軸的活化及海馬迴神經生成。該HPA軸為神經內分泌系統的主要部分,其能控制對於壓力的反應並調控許多身體過程,包括消化、免疫系統、心情和情緒、性取向(sexuality)及能量儲存及消耗。其為腺體、激素與調解一般適應症候群之部分中腦之間交互作用的共同機制。
另一個機制為海馬迴中腦源性神經營養因子(BDNF)的調節作用。BDNF作用在中樞神經系統及周
邊神經系統的某種神經元上,其助於支持現存神經元的存活,及促進新神經元及突觸的生長及分化。在腦中,BDNF在海馬迴、皮層及前腦基底部中活化,該些部位為重要的學習、記憶、及高級思考區域。BDNF本身對於長期記憶是重要的。雖然在哺乳動物腦中絕大多數的神經元是產前所形成的,但部分的成人腦在已知為神經新生的過程中保有從神經幹細胞生長新神經元的能力。神經滋養因子為幫助刺激及控制神經新生的化學物質,BDNF為最為活耀的一種。不具有製造BDNF能力的出生老鼠在腦部及感覺神經系統會有發育缺陷,且通常在分娩後會很快死亡,表示BDNF對於正常神經發育扮演重要的角色。
本組成物亦限制循環介白素6(IL-6)及趨化介素(C-C模體(motif))配體2(CCL2)的量。IL-6為一種促炎細胞激素(proinflammatory cytokine),其已知在許多疾病能刺激發炎及自體免疫過程,該疾病諸如糖尿病、動脈粥樣硬化、抑鬱症、阿茲海默氏病、系統性紅斑狼瘡、多發性骨髓瘤、前列腺癌、白塞氏病、和類風濕性關節炎。另外,晚期/轉移性癌症病患在其血液中具有較高水平的IL-6。顯示出IL-6會經由影響腦中的後生修飾作用(epigenetic modification)而導致多種神經學疾病。IL-6活化磷脂肌醇-3-激酶(PI3K)路徑,且此路徑下游標的為蛋白激酶B(PKB)。IL-6亦涉及與精神疾病(諸如精神分裂症和抑鬱症)相關的路徑。CCL2為一種屬於CC趨化介素家族的小細胞激素。CCL2將單核球、
記憶T細胞及樹突細胞吸引至由組織損傷或感染所產生的發炎反應位置。
本組成物可另外促進諸如5-羥基色胺酸(5-HT)之腸道激素從內分泌細胞釋放。5-HT為天然產生的胺基酸與在生物合成神經傳導物質血清素及褪黑激素中的代謝性中間產物。
又另一個本營養組成物之有助於有益胃腸及神經學助益的可能機制為刺激傳入(感覺)神經路徑,包括迷走神經或交感神經傳導物質,因此促進健康腦部發育。本組成物亦可調節涉及認知基因的路徑。
可以任何該技術領域中已知形式提供所揭示之營養組成物,諸如粉末、膠狀、懸浮物、糊狀、固體、液體、液體濃縮物、可復水粉末代乳品(reconstitutable powdered milk substitute)或即用產品。在某些具體實例中,該營養組成物可包含營養補充品、孩童的營養產品、嬰兒配方、人乳強化劑、成長乳或任合其他針對兒童個體所設計之營養組成物。本揭示內容的營養組成物包括例如口服攝取、促進健康的物質,其包括例如食品,飲料,片劑,膠囊和粉末。此外,可將本揭示內容的營養組成物標準化為特定的卡路里含量,可將其提供為即用產品,或可將其以濃縮形式提供。在一些具體實例中,該營養組成物為粒子尺寸在5μm至1500μm之範圍內的粉末形式,更佳為在10μm至1000μm之範圍內,且甚至更佳在50μm至300μm之範圍內。
在一些具體實例中,該營養組成物為適用於年齡介於從0至12個月、從0至3個月、從0至6個月或從6至12個月的嬰兒配方。在其他具體實例中,該揭示內容提供針對年齡1-3歲及/或4-6歲孩童所設計之一種以強化乳為底質之成長乳,其中該成長乳支持生長及發育及終生健康。
在一個具體實例中,該營養組成物為一種嬰兒配方,可將HMO、益生菌、GOS和PDX的組合添加至市售的嬰兒配方。可將例如Enfalac、Enfamil®、Enfamil®早產配方、含鐵之Enfamil®、Enfamil®LIPIL®、Lactofree®、Nutramigen®、Pregestimil®、及ProSobee®(得自美強生公司,埃文斯維爾,於美國)與PDX、GOS、HMO及LGG加以補充,且可將其用於目前揭示內容的實務中。
正如所述,所揭示的該營養組成物可包含蛋白質來源。該蛋白質來源可為該技術中所使用的任一者,例如脫脂奶粉、乳清蛋白、酪蛋白、大豆蛋白、水解蛋白、胺基酸等。可用於實施本揭示內容的牛乳蛋白質來源包括(但不限於)乳蛋白粉、乳蛋白濃縮物,乳蛋白分離物,脫脂乳固體,脫脂乳,脫脂奶粉,乳清蛋白,乳清蛋白分離物,乳清蛋白濃縮物,甜乳清,酸乳清,酪蛋白,酸酪蛋白,酪蛋白酸鹽(例如酪蛋白酸鈉,鈉酪蛋白酸鈉鈣,酪蛋白酸鈣)及其任意的組合。
在一個具體實例中,將該營養組成物之蛋白質
提供為完整蛋白質。在其他具體實例中,將該蛋白質提供為完整蛋白質和部分水解蛋白質兩者的組合,其具有介於約4%及10%的水解度。在某些其他具體實例中,該蛋白質是更完全水解。在又其他具體實例中,該蛋白質來源包含胺基酸作為蛋白質均等物。在又另一個具體實例中,該蛋白質來源可以含麩醯胺酸的肽進行補充。
在該營養組成物之特定的具體實例中,蛋白質來源的乳清:酪蛋白的比例與人母乳中的比例相似。在一具體實例中,該蛋白質來源包含從約40%至約90%的乳清蛋白和從約10%至約60%的酪蛋白。
在一些具體實例中,該營養組成物包含每100kcal介於約1g和約7g之間的蛋白質來源。在其他具體實例中,該營養組成物包含每100kcal介於約3.5g和約4.5g之間的蛋白質。
適用於本揭示內容之營養組成物的脂肪或脂質來源可為已知或該技術所使用的任一者,包括但不限於動物來源,例如乳脂、奶油、乳酪脂、蛋黃脂質;海洋來源,諸如魚油、海洋石油(marine oil)、單細胞油;蔬菜及植物油,諸如玉米油、菜籽油、葵花油、大豆油、棕櫚油、椰子油、高油酸葵花油、月見草油、菜籽油、橄欖油、亞麻籽(亞麻仁)油、棉籽油、高油酸紅花油、棕櫚硬脂、棕櫚仁油、小麥胚芽油;中鏈三酸甘油脂油和乳液和脂肪酸酯;及彼等之任何組合。
碳水化合物來源可為用於該技術中任一者,例
如乳糖、葡萄糖、果糖、玉米糖漿固體、麥芽糊精、蔗糖、澱粉、米糖漿固體等。在該營養組成物中碳水化合物通常的變化量介於約5g至約25g/100kcal。
在一些具體實例中,該營養組成物可包括除了GOS和PDX之外的益生質。在一些具體實例中,另外可用於本揭示內容的益生質可包括乳酮糖、乳果寡醣(lactosucrose)、棉子糖、葡萄糖-寡醣、菊糖、果-寡醣、異麥芽-寡醣、大豆寡醣、乳果寡醣(lactosucrose)、木糖-寡醣、幾丁-寡醣(chito-oligosaccharide)、甘露-寡醣、阿拉伯-寡醣(aribino-oligosaccharide)、唾液-寡醣(siallyl-oligosaccharide)、岩藻糖-寡醣(fuco-oligosaccharide)及龍膽-寡醣(gentio-oligosaccharide)。在不包括其各自濃度範圍上限之GOS和PDX的具體實例中,可包括高達所指定的上限濃度的另外益生質。
在一些具體實例中,本揭示內容的營養組成物可包含乳鐵蛋白。取決於物種,乳鐵蛋白為含有1-4個聚醣(glycan)之約80kD的單鏈多肽。不同物種之乳鐵蛋白的3-D結構非常相似,但不相同。乳鐵蛋白各包含兩個同源瓣(homologous lobe),稱為N-及C-瓣,分別參見該分子的N-端及C-端部分。各個瓣進一步由兩個子瓣(sub-lobe)或區域所組成,其形成一個裂口,其中鐵離子(Fe3+)與(雙)碳酸鹽陰離子以協同作用的方式緊密結合。這些區域分別稱為N1、N2、C1及C2。乳鐵蛋白的N-端具有負責若干重要結合特徵的強陽離子胜肽區
域。乳鐵蛋白具有非常高的等電點(~pI 9),且其陽離子性質對於對抗細菌、病毒及真菌病源的防禦能力有重要的作用。在乳鐵蛋白的N-端區域內有多群的陽離子胺基酸殘基,其能調解乳鐵蛋白抵抗廣泛微生物的生物活性。
用於本揭示內容之乳鐵蛋白可例如由非人動物或藉由基因改造生物所產生的乳所分離出。在一些具體實例中,本文所述之口服電解質溶液包含非人乳鐵蛋白、由基因改造生物所產生的非人乳鐵蛋白和/或由基因改造生物所產生的人乳鐵蛋白。
用於本揭示內容之合適的非人乳鐵蛋白包括(但不限於)與人乳鐵蛋白之胺基酸序列具有至少48%同源性之非人乳鐵蛋白。譬如,牛乳鐵蛋白(“bLF”)具有與人乳鐵蛋白約70%序列同源性之胺基酸組成物。在一些具體實例中,該非人乳鐵蛋白與人乳鐵蛋白具有至少65%同源性,且在一些具體實例中,具有至少75%同源性。用於本揭示內容之可接受的非人乳鐵蛋白包括(但不限於)bLF、豬乳鐵蛋白、馬乳鐵蛋白、水牛乳鐵蛋白、山羊乳鐵蛋白、鼠乳鐵蛋白及駱駝乳鐵蛋白。
在一些具體實例中,本揭示內容之營養組成物包含非人乳鐵蛋白,例如bLF。bLF為一種屬於鐵運輸蛋白或傳遞家族的醣蛋白。其係由牛乳中分離,其中發現其為乳清蛋白的成分。已知在人乳鐵蛋白和bLF有胺基酸序列、醣化作用形式及鐵結合能力之間的差異。另外,從牛乳分離bLF包括有多個及依序處理步驟,其影響所產生
bLF製品的物理化學性質。亦據說人乳鐵蛋白及bLF與人腸道中乳鐵蛋白受體的結合能力有差異。
雖然不希望受限於此或任何其他理論,但據信從全脂乳所分離之bLF比從乳粉所分離出之bLF具有較少之脂多醣(LPS)初始結合。另外,據信有較低體細胞數的bLF具有較少初始結合的LPS。具有較少初始結合LPS之bLF表面具有更多結合位。這被認為有助於使bLF結合至適當的位置並破壞感染程序。
適用於本揭示內容之bLF可藉由該技術中已知的任何方法製造。例如,在美國專利編號4,791,193中(將其以整體引用方式併入本文),Okonogi等人揭示一種用於製造高純度牛乳鐵蛋白的方法。通常,所揭示的方法包括三個步驟。首先將乳原料與弱酸性陽離子交換器接觸以吸附乳鐵蛋白,接著第二步驟為清洗以移除未吸附的物質。接著為去吸附步驟,其中移除乳鐵蛋白以製造純化的牛乳鐵蛋白。其他的方法可包括如美國專利編號7,368,141、5,849,885、5,919,913及5,861,491中所述的步驟,將其全部揭示內容以整體引用方式併入本文。
在某些具體實例中,用於本揭示內容的乳鐵蛋白可藉由從乳源分離蛋白質之膨脹床吸附(expanded bed absorption,“EBA”)方法提供。EBA(有時亦稱為穩定流體床吸附)為用於從乳源分離諸如乳鐵蛋白之乳蛋白的方法,EBA包含建立包含微粒基質之膨脹床吸附管柱、施加乳源至該基質、及以包含約0.3至約2.0M氯化鈉之沖
提緩衝液由基質沖提乳鐵蛋白。任何哺乳類乳源可用於本方法中,雖然在特定的具體實例中,該乳源為牛乳源。在一些具體實例中,該乳源包含全脂乳、低脂乳、脫脂乳、乳清、酪蛋白或其混合物。
在特定的具體實例中,該標的蛋白為乳鐵蛋白,雖然亦可分離出諸如乳過氧化酶或乳白蛋白之其他乳蛋白質。在一些具體實例中,該方法包含以下步驟:建立包含微粒基質之膨脹床吸附管柱、施加乳源至該基質、及以約0.3至約2.0M氯化鈉由基質沖提乳鐵蛋白。在其他具體實例中,該乳鐵蛋白以約0.5至約1.0M氯化鈉沖提,又在另外的具體實例中,該乳鐵蛋白以約0.7至約0.9M氯化鈉沖提。
該膨脹床吸附管柱可為該技術中已知的任一者,諸如美國專利編號7,812,138、6,620,326及6,977,046中所述者,在此將其揭示內容以引用方式併入本文。在一些具體實例中,將乳源施加至膨脹模式之管柱,且該沖提以膨脹或緊密模式進行。在特定的具體實例中,該沖提以膨脹模式進行。例如,該膨脹模式之該膨脹比可為約1至約3、或約1.3至約1.7。EBA技術進一步描述於國際公開申請案號WO 92/00799、WO 02/18237、WO 97/17132,在此將其以整體引用方式併入本文。
該乳鐵蛋白的等電點約為8.9。先前分離乳鐵蛋白的EBA方法使用200mM之氫氧化鈉作為沖提緩衝液。因此,系統之pH上升至超過12,且可藉由不可逆的
結構改變包含乳鐵蛋白之結構及生物活性。目前已發現氯化鈉溶液可用作為從EBA基質分離乳鐵蛋白的沖提緩衝液。在某些具體實例中,該氯化鈉具有約0.3M至約2.0M的濃度。在其他具體實例中,該乳鐵蛋白沖提緩衝液具有約0.3M至約1.5M、或約0.5M至約1.0M的氯化鈉濃度。
在其他具體實例中,用於本揭示內容之組成物的乳鐵蛋白可經由使用徑向層析法或帶電膜所分離,如同該技術領域人士所熟知者。
用在某些具體實例中的乳鐵蛋白可為分離自全脂乳及/或具有低體細胞數之任何乳鐵蛋白,其中「低體細胞數」是指體細胞數少於200,000細胞/mL。舉例來說,適合的乳鐵蛋白可得自紐西蘭莫林斯維爾(Morrinsville)之Tatua Co-operative Dairy Co.Ltd.、自荷蘭(Netherlands)阿默斯福特(Amersfoort)之FrieslandCampina Domo或自紐西蘭奧克蘭(Auckland)之Fonterra Co-Operative Group Limited。
令人驚訝地,即使暴露在低pH(即,低於約7,且甚至低至約4.6或以下)及/或高溫(即,高於約65℃、及高達約120℃)(預期會破壞或嚴重限制人乳鐵蛋白的穩定性或活性的條件),本文所包括之乳鐵蛋白會維持某種殺菌活性。可預期在用於本文所述類型之營養組成物的某種處理方法期間的這些低pH及/或高溫條件,諸如低溫殺菌。因此,即使在處理方法之後,乳鐵蛋白具有對
抗人腸道中不欲之細菌病源的殺菌活性。在一些具體實例中,該營養組成物可包含從約25mg/100mL至約150mg/100mL的量之乳鐵蛋白。在其他具體實例中,乳鐵蛋白的含量為從約60mg/100mL至約120mg/100mL。在又其他的具體實例中,乳鐵蛋白的含量從約85mg/100mL至約110mg/100mL。
在一具體實例中,本揭示內容之營養組成物包含膽鹼。膽鹼為正常細胞功能必需的營養素。其為膜磷脂質的前驅物,且其加速乙醯膽鹼(包含在記憶儲存器內之神經傳導物質)的合成及釋放。另外,雖然不希望受限於此或任何其他理論,但相信飲食膽鹼及二十二碳六烯酸(DHA)會協同作用以促進卵磷脂的生物合成,且因此幫助促進人個體中的突觸新生。另外,膽鹼及DHA可展現促進樹突棘(dendritic spine)形成的協同功效,其對於維持所建立之突觸連接是重要的。在一些具體實例中,本揭示內容之營養組成物包括每次服用約40mg至每服用8oz.約100mg的膽鹼。
在一具體實例中,該營養組成物包含鐵來源。在一具體實例中,該鐵來源為焦磷酸鐵、正磷酸鐵、反丁烯二酸亞鐵或彼等之混合物,且在一些具體實例中,該鐵來源可裝在膠囊中。
一或多種維生素及/或礦物質亦可以足夠量添加至該營養組成物以供應個體的每日營養需求。該所屬技術領域中具有通常知識者可了解維生素及礦物質需求會改
變,例如,基於個體的年齡。舉例而言,嬰兒與介於一至十三歲的孩童可能具有不同的維生素及礦物質需求。因此,該具體實例不欲限制該營養組成物至特定年齡族群,但反而提供可接受之維生素及礦物質成分的範圍。
在某些具體實例中,該組成物可任意地包括(但不限於)一或多種下述的維生素或其衍生物:維生素B1(噻胺、焦磷酸噻胺、TPP、三磷酸噻胺、TTP、鹽酸噻胺、噻胺硝酸鹽)、維生素B2(核糖黃素、黃素單核苷酸、FMN、黃素腺雙核苷酸、FAD、乳黃素、卵核黃素)、維生素B3(菸鹼、菸鹼酸、菸鹼醯胺、3-吡啶甲醯胺、菸鹼醯胺腺二核苷酸、NAD、菸鹼酸單核苷酸、NicMN、吡啶-3-羧酸)、維生素B3-前驅物色胺酸、他命B6(吡哆醇、吡哆醛、吡哆胺、鹽酸吡哆醇)、泛酸(泛酸鹽、泛醇)、葉酸鹽(葉酸、葉酸素、喋醯麩胺酸)、維生素B12(鈷胺素、甲基鈷胺素、脫氧腺苷鈷胺素、氰鈷銨素、羥基鈷胺素、腺苷鈷銨素)、生物素、維生素C(抗壞血酸)、維生素A(視黃醇、乙酸視黃酯、軟脂酸視網酯、具有其他長鏈脂肪酸之視網酯類、視黃醛、視黃酸、視黃醇酯類)、維生素D(鈣化醇、膽鈣化醇、維生素D3、1,25,-二羥維生素D)、維生素E(α-生育酚、α-生育酚乙酸鹽、α-生育酚琥珀酸鹽、α-生育酚菸酸鹽、α-生育酚)、維生素K(維生素K1、葉醌、萘醌、維生素K2、甲萘醌-7、維生素K3、甲萘醌-4、甲萘醌、甲萘醌-8、甲萘醌-8H、甲萘醌-9、甲萘醌-9H、甲萘醌-10、甲萘
醌-11、甲萘醌-12、甲萘醌-13)、膽鹼、肌醇、β-胡蘿蔔素及彼等之任何組合。
在其他具體實例中,該組成物可任意地包括(但不限於)一或多種以下的礦物質或其衍生物:硼、鈣、乙酸鈣、葡萄糖酸鈣、氯化鈣、乳酸鈣、磷酸鈣、硫酸鈣、氯、鉻、氯化鉻、吡啶甲酸鉻(chromium picolonate)、銅、硫酸銅、葡萄糖酸銅、硫酸銅(II)、氟、鐵、羰基鐵、三價鐵(ferric iron)、反丁烯二酸亞鐵、正磷酸鐵、研製鐵(iron trituration)、多醣鐵、碘化物、碘、鎂、碳酸鎂、氫氧化鎂、氧化鎂、硬脂酸鎂、硫酸鎂、錳、鉬、磷、鉀、磷酸鉀、碘化鉀、氯化鉀、乙酸鉀、硒、硫、鈉、琥珀酸辛酯磺酸鈉、氯化鈉、硒酸鈉、鉬酸鈉、鋅、氧化鋅、硫酸鋅及彼等之混合物。礦物質化合物之非限制例示性衍生物包括任何礦物質化合物之鹽類、鹼性鹽類、酯類及螯合物。
該些礦物質可以鹽類形式(諸如磷酸鈣、甘油磷酸鈣、檸檬酸鈉、氯化鉀、磷酸鉀、磷酸鎂、硫酸亞鐵、硫酸鋅、硫酸銅(II)、硫酸錳及亞硒酸鈉)添加至成長乳或至其他孩童之營養組成物。另外的維生素及礦物質可以該技術領域中已知的方式添加。
在一具體實例中,每次服用維生素A、C及E、鋅、鐵、碘、硒及膽鹼,針對任何特定國家,該孩童的營養組成物可含有介於約10至約50%的最大飲食建議量,或針對一群國家介於約10至約50%的平均飲食建議
量。在另一個具體實例中,每次服用B-維生素,針對任何特定國家,該孩童的營養組成物可供應約10-30%的最大飲食建議量,或針對一群國家約10-30%的平均飲食建議量。在又另一個具體實例中,在孩童之營養產品中維生素D、鈣、鎂、磷及鉀的含量可對應於在乳品中的平均含量。在其他具體實例中,針對任何特定國家,孩童之營養組成物中每次服用的其他營養素可存在約20%的最大飲食建議量、或針對一群國家約20%的平均飲食建議量。
本揭示內容之孩童營養組成物可任意地包括一或多種以下的調味劑,包括但不限於調味精、揮發性油、可可或巧克力調味料、花生醬調味料、餅乾屑、香草或任何市售調味料。可使用之調味料的實例包括但不限於純茴香萃取物、人造香蕉萃取物、人造櫻桃萃取物、巧克力萃取物、純檸檬萃取物、純柑橘萃取物、純薄荷萃取物、蜂蜜、人造鳳梨萃取物、人造糖蜜酒萃取物、人造草莓萃取物、或香草萃取物;或諸如香水薄荷油(balm oil)、月桂油(bay oil)、香柑油、雪松木油、櫻桃油、肉桂油、丁香油、或薄荷油之揮發性油;花生醬、巧克力調味料、香草餅乾屑、白脫糖、太妃糖、及彼等之混合物。調味劑的用量變化極度取決於所使用之調味劑。可以該技術領域中已知的方式選擇調味劑的類型及用量。
本揭示內容之營養組成物可任意地包括一或多種乳化劑,可添加該乳化劑以提供最終產物之穩定性。適合的乳化劑實例包括(但不限於)卵磷脂(例如,從蛋或
大豆)、α-乳清蛋白及/或單及雙甘油酯、及其混合物。其他的乳化劑對於該技術領域人士而言為顯而易知的,且選擇適合的乳化劑將(部分)取決於最終產物的配方。
本揭示內容之營養組成物可任意地包括一或多種防腐劑,可添加該防腐劑以延長產品保存期間。合適的防腐劑包括但不限於已二烯酸鉀、已二烯酸鈉、苯甲酸鉀、苯甲酸鈉、乙二胺四乙酸二鈉鈣及彼等之混合物。
本揭示內容之營養組成物可任意地包括一或多種穩定劑。適用於實施本揭示內容之營養組成物的穩定劑包括但不限於阿拉伯膠、印度膠、加拉亞膠、龍鬚膠、洋菜膠、叉紅藻膠、瓜爾膠、結冷膠、刺槐豆膠、果膠、低甲氧基果膠、明膠、微晶纖維素、CMC(羧甲基纖維素鈉)、甲基纖維素、羥丙基甲纖維素、羥丙基纖維素、DATEM(單-及雙甘油酯之雙乙醯酒石酸酯)、葡聚糖(dextran)、紅藻膠及彼等之混合物。
本揭示內容之營養組成物可提供最小、部份或全部的營養供給。該組成物可為營養補充品或代餐。該組成物可(但不限於)為營養完整的。在一具體實例中,本揭示內容之營養組成物為營養完整的且含有適當種類及含量的脂質、碳水化合物、蛋白質、維生素及礦物質。該脂質或脂肪的含量變化典型地從約2至約7g/100kcal。該蛋白質的含量變化典型地從約1至約5g/100kcal。該碳水化合物的含量變化典型地從約8至約14g/100kcal。
在一些具體實例中,本揭示內容之營養組成物
為成長乳。成長乳為針對年齡大於一歲的孩童(典型年齡從1-6歲)之以強化乳為底質的飲料。它們不是醫療食品且也不打算被用作為解決特定營養缺乏的代餐或補充品。反而,設計成長乳的目的是作為多種飲食的補體(completment),以另外保證提供孩童達到持續每天攝取所有必需維生素及礦物質、巨量營養素加上另外的功能性飲食成分(諸如聲稱具有促進健康特性之非必需營養素)。
根據本揭示內容之嬰兒配方或成長乳或其他營養組成物的萃取組成物按市場會有所不同,其取決於所關注群體之當地規範及飲食攝取資訊。在一些具體實例中,根據本揭示內容之營養組成物由乳蛋白來源(諸如全脂或脫脂乳)加上所添加之用以達成所欲感官性質之糖及甜味劑,及所添加的維生素及礦物質所組成。該脂肪組成物典型地衍生自乳原料。可將總蛋白質定訂為符合人乳、牛乳或較低數值之總蛋白質。通常將總碳水化合物訂定為提供小量添加的糖(諸如蔗糖或果糖),以達到可能可接受的味道。典型地,維生素A、鈣及維生素D的添加量符合區域性牛乳的營養貢獻。另外,在一些具體實例中,維生素及礦物質所添加的量可提供每次服用大約20%的飲食參考攝取量(dietary reference intake,DRI)或20%的每日所需(Daily Value(DV))。此外,在不同市場間之營養素數值可能有所不同,取決於所欲群體所認定之營養需求、原料貢獻及區域規範。
該兒童個體可為孩童或嬰兒。例如,該個體可為年齡介於0至3個月、約0至6個月、0至12個月、3至6個月或6至12個月的嬰兒。或者該個體可為年齡介於從1至13歲、1至6歲、或1至3歲的孩童。在一具體實例中,該組成物可在出生前、幼兒期間、及童年期間投予至兒童個體。
提供實例以解釋本揭示內容之營養組成物的一些具體實例,但不應解釋為加諸於其之任何限制。基於考慮本文所揭示之營養組成物或方法的說明書或實施,本文申請專利範圍內的其它具體實例對於該所屬技術領域中具有通常知識而言為顯而易知的。意欲使說明書與實例僅視為具有例示性,本揭示內容之範圍及精神藉由在實例之後的申請專利範圍所指明。
此研究旨在確定支持有益共生微生物生長的益生質寡醣是否將減弱壓力源所誘發之焦慮樣行為。簡而言之,以標準的實驗室食物或含有乳寡醣3’唾液乳糖(3SL)或6’唾液乳糖(6SL)的實驗室食物餵養小鼠(6-8周齡)兩週,然後使小鼠暴露於一個社會分裂壓力源或無壓力的對照組條件。在社會混亂壓力源模式中,如果小鼠花更少的時間在開放領域中央和有更多的時間在周圍,他們被描述為具有在開放領域的焦慮樣行為。在我們
的研究中,暴露至壓力源會造成餵食對照組飲食小鼠的焦慮樣行為。在亮:暗偏好測試中,相較於無壓力的對照組小鼠,暴露至壓力源的小鼠顯然花更多的時間在暗處(圖1),且花更多時間在開放領域周圍(圖2)。然而,餵食3SL或6SL的暴露至壓力源及無壓力小鼠之行為在亮:暗偏好任務及開放領域兩者中的行為相似,顯示這些益生質可減弱壓力源對於焦慮樣行為的影響。以實驗性飲食處理之動物的代表性移動軌跡係顯示於圖3。該3SL飲食造成在光亮區域中的多數移動,其表示壓力源對於焦慮樣行為的影響下降。
唾液酸(SA)為人乳寡醣及神經組織的關鍵成分。在新生兒發育期間SA快速累積在腦中且被認為對於腦部發育有重要作用。本研究目標在於確定是否唾液乳糖(3’唾液乳糖及6’唾液乳糖)的不同異構物會富集發育中新生仔豬的腦部SA酸。將日齡豬隨機分配於6種飲食(對照組、2g/L 3’-SL、4g/L 3’-SL、2g/L 6’-SL、或4g/L 6’-SL;2g/L PDX+2g/L GOS;n=9),且每日餵食三次經21天。仿照足月人類嬰兒配方(formula)之基礎飲食,調整至符合新生豬隻的營養需求。仔豬在實驗期間迅速地消耗該配方、以正常速率生長及維持臨床健康。飲食性SL並未影響飼料攝取、生長或糞便的一致性。在第21天將豬隻安樂死,並將左半腦解剖為大腦、小腦、胼胝體和
海馬區。以氯仿:甲醇(2:1)將全部及結合脂質的(神經結苷酯)SA萃取後進行下列分析,且將游離SA進行差異計算。將結合蛋白質的SA懸浮於含有1%Triton X-100的PBS後在不可溶殘渣中進行測量。使用修改之過碘酸-間苯二酚反應測定SA。在餵食2g/L之3’-SL(359±16ug SA/g濕組織)或6’-SL(361±16ug SA/g)的豬隻胼胝體中結合神經結苷酯的SA比對照組豬隻(314±16ug SA/g;P<0.05;圖4)增加15%。同樣地,在餵食4g/L之3’-SL(416±14ug SA/g)的豬隻小腦中結合神經結苷酯的SA比對照組豬隻(377±14ug SA/g;P<0.05;圖5)增加10%。綜上,具有3’-或6’-SL的配方之補充品可富集哺乳仔豬腦中的神經結苷酯SA。
Claims (21)
- 一種營養組成物,其包含:(i)蛋白質來源,(ii)脂質來源,(iii)碳水化合物來源,(iv)人乳寡醣或其前驅物,(v)益生質,其包含聚右旋糖(polydextrose)、半乳-寡醣(galacto-oligosaccharide)、或彼等之組合,及(vi)益生菌。
- 如請求項1之組成物,其中該至少一種人乳寡醣包含2’-岩藻糖基乳糖(2’-fucosyllactose)、3’-岩藻糖基乳糖、3’唾液乳糖(3’sialyllactose)、6’唾液乳糖、乳-N-二糖(lacto-N-biose)、乳-N-新四糖(lacto-N-neotetraose)、乳-N-四糖(lacto-N-tetraose)或彼等之任何組合。
- 如請求項1之組成物,其中該人乳寡醣前驅物包含唾液酸、岩藻糖或彼等之組合。
- 如請求項1之組成物,其中該人乳寡醣之濃度介於約0.005g/100kcal至約1g/100kcal。
- 如請求項1之組成物,其中該益生質包含重量比介於約1:4至約4:1之聚右旋糖及半乳寡醣。
- 如請求項1之組成物,其中該聚右旋糖的量介於約0.1g/100kcal至約0.5g/100kcal。
- 如請求項1之組成物,其中該半乳寡醣在該組成 物中的含量介於約0.1g/100kcal至約1.0g/100kcal。
- 如請求項1之組成物,其中該益生菌包含乳酸桿菌(Lactobacillus species)。
- 如請求項1之組成物,其中該益生菌包含鼠李糖乳酸桿菌(Lactobacillus rhamnosus GG)。
- 如請求項1之組成物,其中該益生菌係非存活的(non-viable)。
- 如請求項1之組成物,其中該益生菌係存活的(viable)。
- 如請求項1之組成物,其中該益生菌為含量介於約1×105cfu/100kcal至約1.5×109cfu/100kcal的鼠李糖乳酸桿菌。
- 如請求項1之組成物,其進一步包含長鏈多不飽和脂肪酸來源。
- 如請求項13之組成物,其中該長鏈多不飽和脂肪酸來源包含二十二碳六烯酸、二十碳四烯酸或彼等之組合。
- 如請求項1之組成物,其進一步包含ß-聚葡萄糖(ß-glucan)來源。
- 如請求項15之組成物,其中該ß-聚葡萄糖來源包含1,3-ß-聚葡萄糖。
- 如請求項1之組成物,其中該組成物包含每100kcal:(i)介於約1g與約7g的蛋白質來源, (ii)介於約1g與約10g的脂質來源,(iii)介於約6g與約22g的碳水化合物來源,(iv)介於約0.005g與約1g的人乳寡醣,(v)介於約0.1g與1.0g的半乳-寡醣,(vi)介於約0.1g與約0.5g的聚右旋糖,及(vii)介於約1×105cfu/100kcal至約1.5×109cfu/100kcal的鼠李糖乳酸桿菌。
- 一種用於促進所需兒童個體胃腸道中有益微生物相(microbiota)生長的方法,該方法包含投予該個體有效量的營養組成物,該營養組成物包含:(i)蛋白質來源,(ii)脂質來源,(iii)碳水化合物來源,(iv)人乳寡醣或其前驅物,(v)益生質,其包含聚右旋糖、半乳-寡醣、或彼等之組合,及(vi)益生菌。
- 如請求項18之方法,其中該組成物的投予刺激個體中腸細菌的生長,其中該腸細菌包含乳酸桿菌、雙叉桿菌(Bifidobacterium species)、支原體(Allobaculum species)或彼等之組合。
- 如請求項18之方法,其中該方法進一步促進個體的認知發育。
- 如請求項18之方法,其中該方法進一步減少個 體腸中梭菌(Clostridium species)的生長。
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- 2015-03-25 MX MX2016012693A patent/MX2016012693A/es unknown
- 2015-03-25 EP EP15715926.0A patent/EP3154376A1/en not_active Withdrawn
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CA2945970A1 (en) | 2015-10-29 |
EP3154376A1 (en) | 2017-04-19 |
CN106255505A (zh) | 2016-12-21 |
MX2016012693A (es) | 2016-12-16 |
WO2015164021A1 (en) | 2015-10-29 |
MY187630A (en) | 2021-10-05 |
AU2015250268A1 (en) | 2016-09-15 |
AU2021200368A1 (en) | 2021-03-18 |
PH12016501953A1 (en) | 2017-01-09 |
SG11201607125RA (en) | 2016-09-29 |
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