TW201429477A - 使用人乳寡糖之用於調節炎症之營養調配物 - Google Patents
使用人乳寡糖之用於調節炎症之營養調配物 Download PDFInfo
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Abstract
本發明揭示營養組合物之用途,其係用於製造用以調節或減輕成年或老年個體之炎症的藥物。亦提供該等營養組合物用於製造藉由減少PNC形成來減輕炎症及降低發炎疾病發病率之藥物的用途。在一些態樣中,該等營養組合物包含中性人乳寡糖。在其他態樣中,該等營養組合物包含酸性人乳寡糖與長鏈聚不飽和脂肪酸及類胡蘿蔔素之組合。
Description
本申請案主張2012年12月20日申請之美國臨時申請案第61/739,923號之權益。
本發明係關於一種營養組合物之用途,其係用於製造用以調節或減輕成年或老年個體之炎症的藥物。更具體言之,在一些態樣中,該等營養組合物藉由減少血小板嗜中性白血球複合物(PNC)形成來減輕炎症及降低發炎疾病發病率。特定言之,在一些態樣中,該等營養組合物包含中性人乳寡糖。在其他態樣中,該等營養組合物包含酸性人乳寡糖與長鏈聚不飽和脂肪酸及類胡蘿蔔素之組合。
發炎反應係身體在傳染物入侵、抗原攻擊或者物理、化學或創傷性損害後恢復及保持體內恆定的嘗試。儘管發炎反應一般視為對損傷之健康反應,但若免疫系統未經適當調控,則其可呈現非所要之生理學反應。具體言之,未經調控之氧化及相關炎症為例如引起成年及老年腫瘤患者中組織損害及臨床上顯著之疾病的主要原因。
含有HMO之乳汁與嬰兒呼吸、腸胃及免疫系統之增強的發育以及平衡的生長及成熟有關,藉此保護嬰兒免受感染及發炎疾病影響。除外源抗氧化劑(諸如維生素A、C、E及硒)外,乳汁看似亦含有內源
抗氧化劑,諸如超氧化歧化酶、麩胱甘肽過氧化酶及過氧化氫酶,或其他非酶促抗氧化劑,諸如麩胱甘肽、乳鐵傳遞蛋白及多酚。此外,乳汁包括HMO,其不僅用作病原體受體類似物,而且還活化免疫因子。此等乳汁組分之功能,起抗氧化劑及免疫調節劑作用,不僅包括藉由過氧化反應保護乳汁脂質,而且亦可幫助調控對感染或其他損傷之發炎反應。
目前沒有可用於使發炎疾病降至最少之疫苗。因此,開發安全且有效之預防或治療方法將為有益的,尤其是對於成年及老年個體。因此,將需要提供營養組合物,且尤其是成人營養組合物配方,其可產生包括改善免疫系統支持及反應在內的營養益處。若營養組合物可調節炎症且增強對微生物感染(包括細菌及病毒感染)及其他發炎疾病之免疫性,則將另外有益。
在一個態樣中,本發明係針對包含約0.001mg/mL至約25mg/mL濃度之中性人乳寡糖之組合物的用途,其係用於製造用以調節或減輕有需要之成年或老年個體之炎症的藥物。
在另一態樣中,本發明係針對包含在約0.001mg/mL至約10mg/mL範圍內之酸性人乳寡糖、濃度不超過營養組合物中總脂肪含量之約5%之長鏈聚不飽和脂肪酸及約0.001μg/mL至約10μg/mL濃度之類胡蘿蔔素之組合物的用途,其係用於製造用以調節有需要之成年或老年個體之炎症的藥物。
圖1. 顯示2'FL及FL混合物可顯著減少PNC形成。培育15分鐘最佳。
術語「殺菌釜封裝」與「殺菌釜滅菌」在本文中可互換使用,
且除非另外說明,否則其係指用營養液填充容器(最通常為金屬罐或其他類似封裝),接著使填充液體之封裝經受必要熱滅菌步驟以形成經滅菌的殺菌釜封裝之營養液產品的慣例。
除非另外說明,否則如本文所用之術語「無菌封裝」係指不依賴上述殺菌釜封裝步驟來製造封裝產品,其中營養液及封裝在填充之前分別進行滅菌,接著在滅菌或無菌加工條件下組合形成經滅菌的無菌封裝之營養液產品。
除非另外說明,否則如本文所用之術語「脂肪」與「油」可互換使用,意指源自植物或動物或者由植物或動物加工得到之脂質材料。此等術語亦包括合成脂質材料,只要該等合成材料適於經口投與人類。
除非另外說明,否則如本文所用之術語「人乳寡糖」或「HMO」一般係指在人類乳汁中發現的可呈酸性或中性形式之許多複合碳水化合物,及其前驅物。例示性非限制性中性人乳寡糖包括3-海藻糖基乳糖、2'-海藻糖基乳糖及乳糖-N-新四糖(LNnT)。例示性人乳寡糖前驅物包括唾液酸、乳糖、海藻糖或其任何組合。
除非另外說明,否則如本文所用之術語「中性人乳寡糖」一般係指包含在生理學pH值下不帶電之單醣,亦即不含唾液酸(N-乙醯基-神經胺糖酸或N-羥乙醯基-神經胺糖酸)之殘基或部分且亦缺乏葡糖胺(亦即非乙醯化葡糖胺)的中性寡糖。中性HMO之濃度範圍可為約0.001mg/mL至約25mg/mL。因此,2'-海藻糖基乳糖之重量範圍的實例可為約0.001mg/mL至約25mg/mL;且LNnT可在約0.001mg/mL至約25mg/mL範圍內。
除非另外說明,否則如本文所用之術語「存放穩定的」係指營養產品在封裝且接著在18-24℃下儲存至少3個月,包括約6個月至約24個月,且亦包括約12個月至約18個月後仍為商業上穩定的。
如本文所用之術語「營養調配物」或「營養組合物」可互換使用,且除非另外說明,否則其係指包括營養液、營養粉末、營養固體、營養半固體、營養半液體、營養補充劑及此項技術中已知之任何其他營養食物產品的合成配方。營養粉末可復原形成營養液,其均包含脂肪、蛋白質及碳水化合物中之一或多者且適於人類經口消費。術語「營養調配物」或「營養組合物」不包括人類乳汁。
除非另外說明,否則如本文所用之術語「營養液」係指即飲液體形式、濃縮形式之營養產品及藉由在使用之前復原本文所述之營養粉末而製成之營養液。
除非另外說明,否則如本文所用之術語「營養粉末」係指可流動或可挖取形式之營養產品,其可在消費之前用水或另一水性液體復原且包括噴霧乾燥及乾式混合/乾式摻合粉末兩者。
除非另外說明,否則如本文所用之術語「營養半固體」係指性質(諸如剛性)介於固體與液體之間的營養產品。一些半固體實例包括布丁狀物、明膠及黏團(dough)。
除非另外說明,否則如本文所用之術語「營養半液體」係指性質(諸如流動性)介於液體與固體之間的營養產品。一些半液體實例包括濃稠奶昔(thick shake)及液體凝膠。
如本文所用之術語「成人」係指成人及約12歲及12歲以上的兒童。
如本文所用之術語「老年個體」係指至少45歲,包括至少50歲、至少55歲、至少60歲、至少65歲、至少70歲、至少75歲且包括至少80歲或超過80歲的個體。術語「老年」亦包括約45歲至約95歲之群體,及約55歲至約80歲之群體。
除非另外說明,否則如本文關於誘導產生單核細胞來源之細胞激素所使用的術語「不存在病毒(absence of a virus)」或「病毒不存
在的(absent a virus)」係指個體不具有病毒或具有的病毒量小於引起免疫反應所需之量;亦即,低於身體之自然免疫反應提高細胞激素及其他免疫因子之產量所需之量。
除非另外說明,否則如本文所用之術語「發炎疾病」或「發炎病狀」係指以炎症為特徵之任何疾病、病症或病狀。除非另外說明,否則如本文所用之術語「感染介導之發炎疾病」係指與微生物感染(包括病毒及細菌感染)有關或由其誘發之發炎疾病。
除非另外說明,否則如本文所用之術語「易感」及「處於風險中」意謂對某種病狀或疾病具有極小抗性,包括該病狀或疾病之遺傳傾向、具有該病狀或疾病之家族史及/或具有該病狀或疾病之症狀。
除非另外說明,否則如本文所用之術語「調節」係指所選特徵之靶向運動。
除非另外說明,否則如本文所用之術語「改善」意謂消除、延遲或降低與病狀有關之症狀的流行或嚴重程度。
術語「有效量」欲限定實現降低患者將經受不良健康事件之風險,同時避免不良副作用(諸如通常與替代療法相關者)之目標的HMO之量。該有效量可分一或多次劑量投與。
除非另外說明,否則如本文所用之術語「治療(treating/treatment)」包括延遲病狀之發作、減輕病狀之症狀的嚴重程度或消除病狀之一些或全部症狀。
除非另外說明,否則如本文所用之術語「病毒生長」或「細菌生長」係指病毒或細菌之產生、增殖或複製。
如本文所用之術語「食物產品」係指含有脂肪、胺基氮及碳水化合物中之一或多者且向患者提供推薦每日量之一些或全部營養支持的遞送媒劑。食物產品通常將含有維生素、礦物質、痕量礦物質及其類似物,以向飲食替代物、醫療食品、補充劑提供平衡營養。食物產
品可為任何典型形式,諸如飲料、粉末、條(bar)、果汁、碳酸飲料、瓶裝水。
除非另外說明,否則如本文所用之所有百分比、份數及比率係以總組合物之重量計。除非另外說明,否則所有該等重量只要是關於所列成分,即基於活性物含量,且因此不包括市售材料中可能包括之溶劑或副產物。
不管是否明確揭示,如本文所用之數值範圍欲包括在該範圍內之每一個數值及數值子集。此外,此等數值範圍應解釋為向針對該範圍內之任何數值或數值子集之技術方案提供支持。舉例而言,揭示1至10應解釋為支持2至8、3至7、5至6、1至9、3.6至4.6、3.5至9.9等之範圍。
除非另外說明或明確指出與提及之上下文相反,否則本發明所有提及之單個特徵或限制應包括相應複數個特徵或限制,且反之亦然。
除非另外說明或明確指出與所提及組合之上下文相反,否則如本文所用之方法或製程步驟之所有組合可以任何順序執行。
PNC(血小板嗜中性白血球複合物)形成之減少表明炎症減輕。當前文獻亦顯示,中性寡糖之彙集混合物不會減少PNC形成,或降低CD11b表現。令人驚奇地是,實驗結果顯示單獨或與3-海藻糖基乳糖(3FL)組合之個別中性人乳寡糖2'-海藻糖基乳糖(2'FL)及乳糖-N-新四糖(LNnT)減少PNC形成。此外,單獨3FL不會減少PNC形成。
已發現,特定中性HMO(諸如2'-海藻糖基乳糖,及乳糖-N-新四糖,2'-海藻糖基乳糖與3-海藻糖基乳糖之組合及本文所述之其他HMO)藉由降低人類免疫細胞中一些關鍵細胞激素之產量,同時不提高病毒負荷(此可導致較快自感染恢復),而在抑制成人常見炎症,且尤其是抑制病毒誘發之炎症(包括呼吸道融合性病毒、人類副流行性
感冒及A型流感)方面特別有效。
PNC形成(血小板-嗜中性白血球複合物)提高且因此炎症加重,且可受益於炎症減輕之群體包括糖尿病患者(尤其女性)、局部缺血患者、活動性鐮狀細胞病患者、血管炎症患者及遭受微生物感染(呼吸道或胃腸感染、敗血症、牙周炎)之患者。其他受益者為處於慢性炎症風險中之彼等成年及老年個體。此可包括運動員、老年人、患有哮喘或過敏症者,且患有發炎性腸病(IBD)者亦可受益於PNC形成減少及由此引起之炎症減輕。
令人驚奇地是,確定此等中性HMO即使在極低濃度(包括低於人類乳汁中發現之濃度的濃度)下亦呈現所要抑制作用。
此外,已發現特定中性HMO當與長鏈聚不飽和脂肪酸及/或類胡蘿蔔素組合時以協同方式對呼吸道病毒(包括RSV)起作用。此等協同作用抑制病毒誘導之發炎性細胞激素,且尤其是干擾素誘導性蛋白質10(IP-10)。亦可向HMO及長鏈聚不飽和脂肪酸及/或類胡蘿蔔素組合中添加包括抗氧化劑(諸如維生素A及維生素E)或核苷酸在內之額外組分。
已另外發現包括酸性/唾液酸化HMO(例如6'-唾液酸基乳糖或3'-唾液酸基乳糖)及/或中性HMO(包括海藻糖基化(例如2'-海藻糖基乳糖)及/或含有n-乙醯基葡萄糖胺(例如LNnT)者)之HMO組合會降低氧化應力。
亦已發現中性HMO 2'-海藻糖基乳糖及2'-海藻糖基乳糖與3-海藻糖基乳糖之混合物會減少血小板嗜中性白血球複合物(PNC)形成。同樣,LNnT使3名個體中之2名的PNC形成減少。
本文所述之營養組合物及方法利用單獨中性或酸性HMO或其與長鏈聚不飽和脂肪酸、抗氧化劑或兩者,且尤其類胡蘿蔔素、核苷酸或兩者的組合來控制及減輕與炎症相關之許多疾病及病狀。在一些態
樣中,本文所述之營養組合物包括合成配方,其包括一種中性HMO,或中性HMO之組合。在其他態樣中,營養組合物利用酸性HMO與長鏈聚不飽和脂肪酸之組合。下文詳細描述營養組合物、方法及其用途之此等及其他特徵,以及許多視情況存在之變化及附加中的一部分。
中性或酸性HMO可調配成適合組合物,且接著根據本發明之方法,以適於所選投與途徑之方式向患者投與。調配物包括(但不限於)適於口服或非經腸(包括皮下、肌肉內、腹膜內、瘤內及靜脈內)投與者。如本文所定義之經口投與包括使中性或酸性HMO通過患者食道的任何投藥形式。舉例而言,經口投與包括鼻飼插管法,其中管自患者鼻子通入胃中以投與食物或藥物。
口服調配物包括適用於本文之任何固體、液體或粉末調配物,其限制條件為該調配物允許安全且有效地經口遞送中性或酸性HMO及視情況存在之營養組分。在較佳實施例中,口服調配物為液體營養組合物。適於經口投與之本發明調配物可呈離散單元,諸如錠劑、糖衣錠、膠囊、***錠、粉片或扁囊劑,其各自含有預定量的呈粉末或顆粒形式或呈水性液體或非水性液體中之溶液或懸浮液形式(諸如糖漿、酏劑、乳液或飲劑)之中性或酸性HMO。
營養組合物及方法可包含如本文所述之組合物及方法之基本要素,以及本文所述或另外適用於營養產品應用的任何其他或視情況存在之要素;由其組成;或基本上由其組成。
本發明之營養組合物包括至少一種中性HMO,且在許多實施例中包括兩種或兩種以上中性HMO之組合。在其他態樣中,營養組合物包括酸性HMO。在特定具體態樣中,營養組合物含有酸性及中性HMO之組合。寡糖為人類乳汁的一種主要組分,其含有平均每公升
10g中性寡糖及每公升1g酸性寡糖。人乳寡糖之組成非常複雜且已知超過200種不同的寡糖樣結構。
營養組合物中可包括單獨中性或酸性HMO,或在一些實施例中,包括其與如本文所述之其他免疫增強因子(例如LCPUFA、抗氧化劑、核苷酸等)之組合。中性或酸性HMO可自哺乳動物分泌之乳汁分離或增濃,該等哺乳動物包括(但不限於):人類、牛、綿羊、豬或山羊物種。中性或酸性HMO亦可經由微生物醱酵、酶促過程、化學合成或其組合來產生。
除上文所述之HMO外,營養組合物亦可包括此項技術中已知的其他中性HMO、酸性HMO,或酸性或中性HMO前驅物。
特別適於營養組合物之HMO包括中性HMO之組合(例如2'FL與3FL或3FL與LNnT)及酸性HMO之組合(例如6'SL與3'SL)。在特定具體態樣中,可使用酸性與中性HMO之組合(例如2'FL與6'SL)。
中性或酸性HMO係以至少約0.001mg/mL,包括至少約0.01mg/mL,包括約0.001mg/mL至約25mg/mL,包括約0.01mg/mL至約20mg/mL,包括約0.01mg/mL至約10mg/mL,包括約0.01mg/mL至約5mg/mL,包括約0.01mg/mL至約1mg/mL,且亦包括約0.001mg/mL至約1mg/mL,包括約0.001mg/mL至約0.23mg/mL,包括約0.01mg/mL至約0.23mg/mL於營養組合物中之總中性或酸性HMO的於組合物中之中性或酸性HMO之總量(每毫升組合物中性或酸性HMO之毫克數)存在於營養組合物中。通常,營養組合物中中性或酸性HMO之量將取決於存在之特定一或多種中性或酸性HMO以及營養組合物中其他組分之量。
在一個具體實施例中,營養組合物包括約0.001mg/mL至約25mg/mL,包括約0.001mg/mL至低於約2mg/mL,且亦包括約0.01mg/mL至約25mg/mL,包括約0.01mg/mL至低於約2mg/mL之量的中
性人乳寡糖。
在另一實施例中,營養組合物包括一或多種選自2'-海藻糖基乳糖及乳糖-N-新四糖之中性人乳寡糖。
在一個具體實施例中,營養組合物包括單獨或與其他HMO組合之LNnT,其濃度為約0.001mg/mL至約25mg/mL,包括約0.001mg/mL至低於0.2mg/mL,亦包括約0.01mg/mL至約25mg/mL,包括約0.01mg/mL至低於約0.2mg/mL,且亦包括大於約0.32mg/mL至約20mg/mL,且亦包括約0.1mg/mL至約5mg/mL。
在另一具體實施例中,營養組合物包括單獨或與其他HMO組合之2'FL,其量為約0.001mg/mL至約25mg/mL,包括約0.001mg/mL至約15mg/mL,包括約0.001mg/mL至低於約2mg/mL,包括約0.001mg/mL至低於約1mg/mL,亦包括約0.01mg/mL至約25mg/mL,包括約0.01mg/mL至約20mg/mL,包括約0.01mg/mL至低於約2mg/mL,包括約0.01mg/mL至低於約1mg/mL,且亦包括大於1.7mg/mL至約20mg/mL,包括大於約2.5mg/mL至約20mg/mL,且亦包括約0.050mg/mL至約10mg/mL,包括約0.1mg/mL至約10mg/mL。
在一個具體實施例中,營養組合物包括2'FL或LNnT與3FL之組合,HMO之總量為0.001mg/mL至約25mg/mL,包括約0.01mg/mL至約25mg/mL,其中3FL係以約0.001mg/mL至約10mg/mL之濃度存在。
在另一實施例中,酸性HMO(例如3'SL或6'SL)係單獨存在或與中性HMO(例如2'FL、LNnT或其組合)組合存在,其濃度為約0.001mg/mL至約10mg/mL。若酸性HMO係單獨存在,則其較佳與聚不飽和脂肪酸、類胡蘿蔔素或兩者組合存在。
除了上述HMO之外,本發明之營養產品可包括LCPUFA。營養組
合物中包括LCPUFA來提供營養支持,以及降低氧化應力並增進腸上皮及相關免疫細胞群體之生長及功能發育。在一些實施例中,營養組合物包括一或多種中性或酸性HMO與一或多種LCPUFA之組合,使得組合物向最終使用者提供協同益處,諸如在調節抗病毒免疫反應及抑制炎症方面之協同益處。在一些實施例中,與LCPUFA組合使用以提供協同作用之HMO為酸性HMO。
用於營養組合物中之例示性LCPUFA包括例如ω-3 LCPUFA及ω-6 LCPUFA。特定LCPUFA包括二十二碳六烯酸(DHA)、二十碳五烯酸(EPA)、二十二碳五烯酸(DPA)、二十碳四烯酸(ARA)、亞麻油酸、次亞麻油酸(α次亞麻油酸)及源自油來源之γ-次亞麻油酸,該等油來源諸如為植物油、海洋浮游生物、真菌油、磷蝦油及魚油。在一個特定實施例中,LCPUFA係源自魚油,諸如鯡魚油、鮭魚油、鯷魚油、鱈魚油、大比目魚油、鮪魚油或鯡魚油。與中性或酸性HMO一起用於營養組合物中之尤佳LCPUFA包括DHA、ARA、EPA、DPA及其組合。
為了減少營養組合物中高劑量LCPUFA之潛在副作用,LCPUFA之含量較佳以營養組合物中總脂肪內含物重量計不超過5%,包括以總脂肪內含物重量計低於2%,且包括以總脂肪內含物重量計低於1%。
提供的LCPUFA可呈游離脂肪酸形式、三酸甘油酯形式、二酸甘油酯形式、單酸甘油酯形式、磷脂形式、酯化形式或上述一或多者之混合物形式,較佳呈三酸甘油酯形式。
如本文所述之營養組合物通常將包含約0.01mM至約10mM且包括約0.01mM至約1mM的LCPUFA總濃度。或者,營養組合物包含約0.001g/L至約1g/L的LCPUFA總濃度。
在一個實施例中,營養組合物包括約100至約425mg/L或約12至約53mg/100kcal濃度的總長鏈ω-6脂肪酸,及/或另外包括約40至約
185mg/L或約5至約23mg/100kcal濃度的總長鏈ω-3脂肪酸。在一個具體實施例中,營養組合物中的長鏈ω-6脂肪酸與長鏈ω-3脂肪酸之比率在約2:1至約3:1範圍內,較佳為約2.5:1。
在一個具體實施例中,營養組合物包括約0.025mg/mL至約0.130mg/mL或約3至約16mg/100kcal濃度之DHA。在另一實施例中,營養組合物包括約0.080mg/mL至約0.250mg/mL或約10至約31mg/100kcal濃度之ARA。在另一實施例中,營養組合物包括DHA與ARA之組合,使得DHA比ARA之比率在約1:4至約1:2範圍內。
此外,營養組合物可包含一或多種抗氧化劑與中性或酸性HMO(以及視情況存在之LCPUFA及/或核苷酸)之組合來提供營養支持,以及降低氧化應力。在一些實施例中,營養組合物包括中性HMO、酸性HMO或兩者與抗氧化劑之組合,使得該組合物向最終使用者提供協同益處,諸如在調節抗病毒免疫反應及抑制炎症方面之協同益處。在一些實施例中,中性或酸性HMO與類胡蘿蔔素(且具體言之葉黃素、β-胡蘿蔔素、玉米黃素及/或番茄紅素)組合使用以提供協同作用。
可包括適於經口投與之任何抗氧化劑用於本發明之營養組合物中,包括例如維生素A、維生素E、維生素C、視黃醇、生育酚,及類胡蘿蔔素,例如包括葉黃素、β-胡蘿蔔素、玉米黃素及番茄紅素,及其組合。
如所述,用於營養組合物之抗氧化劑可與單獨中性或酸性HMO一起使用,或與中性或酸性HMO及LCPUFA及/或核苷酸組合使用。在一個具體實施例中,用於營養組合物中之抗氧化劑包括類胡蘿蔔素,且尤其類胡蘿蔔素、葉黃素、番茄紅素、玉米黃素及/或β-胡蘿蔔素之組合。如本文所選擇及定義的含有此等組合之營養組合物可用
於調節炎症及/或C反應蛋白含量。
營養組合物一般較佳包含至少一種選自葉黃素、番茄紅素、玉米黃素及β-胡蘿蔔素之類胡蘿蔔素以提供約0.001μg/mL至約10μg/mL總量之類胡蘿蔔素。更具體言之,營養組合物包含約0.001μg/mL至約10μg/mL,包括約0.001μg/mL至約5μg/mL,包括約0.001μg/mL至約0.0190μg/mL,包括約0.001μg/mL至約0.0140μg/mL,且亦包括約0.044μg/mL至約5μg/mL葉黃素之量的葉黃素。營養組合物一般亦較佳包含約0.001μg/mL至約10μg/mL,包括約0.001μg/mL至約5μg/mL、約0.001μg/mL至約0.0130μg/mL,包括約0.001μg/mL至約0.0075μg/mL,且亦包括約0.0185μg/mL至約5μg/mL番茄紅素。營養組合物一般亦較佳包含約1μg/mL至約10μg/mL,包括約1μg/mL至約5μg/mL,包括約0.001μg/mL至約0.025μg/mL,包括約0.001μg/mL至約0.011μg/mL,且亦包括約0.034μg/mL至約5μg/mLβ-胡蘿蔔素。應理解,本發明之營養組合物中可包括此等量之β-胡蘿蔔素、葉黃素、玉米黃素及番茄紅素的任何組合。如本文所述之營養組合物中可視情況包括其他類胡蘿蔔素。本文所述之營養組合物中包括的任一種或所有類胡蘿蔔素可來自天然來源或為人工合成的。在一個特定實施例中,營養組合物包含中性HMO、2'FL與番茄紅素之組合。
類胡蘿蔔素可自適用於營養組合物中的任何已知或另外適合之材料來源獲得,且其各自可個別地提供或一起提供,或以任何組合提供且來自許多來源,包括諸如含有其他維生素或礦物質與一或多種如本文所述之類胡蘿蔔素之組合的綜合維生素預混物的來源。葉黃素、番茄紅素、β-胡蘿蔔素或其組合之一些適合來源的非限制性實例包括LycoVit®番茄紅素(可購自BASF,Mount Olive,N.J.);呈油、粉末或珠粒形式之Lyc-O-Mato®番茄提取物(可購自LycoRed Corp.,Orange,N.J.);β-胡蘿蔔素、葉黃素或番茄紅素(可購自DSM Nutritional
Products,Parsippany,N.J.);FloraGLO®葉黃素(可購自Kemin Health,Des Moines,Iowa);Xangold®天然葉黃素酯(可購自Cognis,Cincinnati,Ohio);及Lucarotin® β-胡蘿蔔素(可購自BASF,Mount Olive,N.J.)。
除中性或酸性HMO之外,本發明之營養組合物可另外包含選自由以下組成之群的核苷酸及/或核苷酸前驅物:核苷、嘌呤鹼基、嘧啶鹼基、核糖及去氧核糖。核苷酸可為單磷酸鹽、二磷酸鹽或三磷酸鹽形式。核苷酸可為核糖核苷酸或去氧核糖核苷酸。核苷酸可為單體、二聚體或多聚體的(包括RNA及DNA)。核苷酸可以游離酸形式或鹽形式,較佳以單鈉鹽形式存在於營養組合物中。在一些實施例中,營養組合物包括中性HMO、酸性HMO或兩者與核苷酸之組合,使得該組合物向最終使用者提供協同益處,諸如在調節抗病毒免疫反應及抑制炎症及/或改善腸屏障完整性方面之協同益處。
在本發明之營養組合物中併入核苷酸會改善腸屏障完整性及/或成熟。
用於營養組合物中之適合核苷酸及/或核苷包括5'-單磷酸胞苷、5'-單磷酸尿苷、5'-單磷酸腺苷、5'-1-單磷酸鳥苷及/或5'-單磷酸肉苷中之一或多者,更佳為5'-單磷酸胞苷、5'-單磷酸尿苷、5'-單磷酸腺苷、5'-單磷酸鳥苷及5'-單磷酸肉苷。
包括中性或酸性HMO之營養組合物可經調配以包括蛋白質、脂肪及碳水化合物中至少一者。在許多實施例中,營養組合物將包括中性或酸性HMO與蛋白質、碳水化合物及脂肪。儘管脂肪、蛋白質及碳水化合物之總濃度或總量可取決於產品類型(亦即,營養配方)、產品形式(亦即,營養固體、粉末、即飲液體或濃縮液)以及預期使用者之目標膳食需要而變化,但該等濃度或量最通常在以下具體範圍中之
一者內,包括如本文所述之任何其他必需脂肪、蛋白質及/或碳水化合物成分在內。
除LCPUFA之外,本發明之營養組合物可包含其他脂肪來源。用於本文中之適合其他脂肪來源包括適用於口服營養產品中且可與該等產品之基本成分及特徵相容的任何脂肪或脂肪來源。脂肪最通常可為乳化脂肪,其濃度以重量計可在約1%至約30%範圍內,包括約2%至約15%且亦包括約4%至約10%。在一個具體實施例中,其他脂肪係源自短鏈脂肪酸。
用於本文所述之營養產品中的適合脂肪或其來源之其他非限制性實例包括椰子油、分餾椰子油、大豆油、玉米油、橄欖油、紅花油、高油酸紅花油、油酸(EMERSOL 6313 OLEIC ACID,Cognis Oleochemicals,Malaysia)、MCT油(中鏈三酸甘油酯)、葵花子油、高油酸葵花子油、棕櫚油及棕櫚仁油、棕櫚液油、菜籽油、水產動物油、魚油、真菌油、海藻油、棉籽油及其組合。二十碳四烯酸及二十二碳六烯酸之脂質來源包括(但不限於)水產動物油、蛋黃油及真菌油或海藻油。
此等脂肪之眾多商業來源容易獲得且為實施此項技術者已知的。舉例而言,大豆油及菜籽油可購自Archer Daniels Midland,Decatur,Ill。玉米油、椰子油、棕櫚油及棕櫚仁油可購自Premier Edible Oils Corporation,Portland,Organ。分餾椰子油可購自Henkel Corporation,LaGrange,Ill。高油酸紅花油及高油酸葵花子油可購自SVO Specialty Products,Eastlake,Ohio。水產動物油可購自Mochida International,Tokyo,Japan。橄欖油可購自Anglia Oils,North Humberside,United Kingdom。葵花子油及棉籽油可購自Cargil,Minneapolis,Minn。紅花油可購自California Oils Corporation,
Richmond,Calif。
除了此等食用級油之外,需要時,可向食物產品中併入結構化脂質。結構化脂質為此項技術中已知的。結構化脂質之簡潔描述可見於INFORM,第8卷,第10期,第1004頁;題為Structured lipids allow fat tailoring(1997年10月)。亦參看美國專利第4,871,768號。結構化脂質主要為在同一甘油核上含有中鏈及長鏈脂肪酸之混合物的三醯基甘油。結構化脂質及其於腸配方中之用途亦描述於美國專利第6,194,379號及第6,160,007號中。
視情況,ω-3脂肪酸可包含至多約30%之油摻合物,該等ω-3脂肪酸較佳主要由較長鏈形式,二十碳五烯酸(EPA)及二十二碳六烯酸(DHA)組成。用於製備營養組合物之膳食油一般含有呈三酸甘油酯形式之ω-3脂肪酸且包括(但不限於)菜籽油、中鏈三酸甘油酯、魚油、大豆油、大豆卵磷脂、玉米油、紅花油、葵花子油、高油酸葵花子油、高油酸紅花油、橄欖油、琉璃苣油、黑酯栗油、月見草油及亞麻籽油。視情況,根據本發明之脂質摻合物中ω-6脂肪酸與ω-3脂肪酸之重量比為約0.1至3.0。ω-3脂肪酸之每日遞送應為至少450mg且可取決於個體之體重、性別、年齡及醫學病況而變化。如所述,需要較高含量供成年人消費:例如每日約0.5至50gm,更佳每日約2.5至5gm。
營養產品可另外包含適用於口服營養產品中且可與該等產品之基本成分及特徵相容的任何蛋白質或其來源。營養液中之總蛋白質濃度以重量計可在約0.5%至約30%範圍內,包括約1%至約15%,包括約2%至約10%,及亦包括約3%至約8%,包括約3%至約7%,且包括約3%至約6.72%。在一個特定實施例中,當營養產品為乳液時,該乳液包括以重量計總濃度為約6.77%之蛋白質。當營養產品為實質上澄清之液體時,該澄清液體包括以重量計總濃度為約3.00%至約4.47%之
蛋白質。
用於營養產品中之適合蛋白質或其來源之非限制性實例包括水解、部分水解或未水解之蛋白質或蛋白質來源,其可源自任何已知或另外適合之來源,諸如乳汁(例如酪蛋白、乳清)、動物(例如肉、魚)、穀類(例如稻、玉米)、蔬菜(例如大豆)或其組合。該等蛋白質之非限制性實例包括乳蛋白分離物、如本文所述之乳蛋白濃縮物、酪蛋白分離物、廣泛水解之酪蛋白、乳清蛋白、酪蛋白鈉或酪蛋白鈣、全脂牛乳、部分或完全脫脂乳、大豆蛋白分離物、大豆蛋白濃縮物等。在一個具體實施例中,營養組合物包括源自人類及/或牛起源之乳蛋白的蛋白質來源。
營養產品中之蛋白質可包括完整蛋白質,該術語在本文中定義為改善產品穩定性且使調配物在存放期間苦味及餘味之產生減至最少。
營養產品可另外包含適用於口服營養產品中且可與該等產品之基本成分及特徵相容的任何碳水化合物。營養液中之碳水化合物濃度例如以重量計可在約5%至約40%範圍內,包括約7%至約30%,包括約10%至約25%。
用於本文所述之營養產品中的適合碳水化合物或其來源之非限制性實例可包括麥芽糊精、水解或改質澱粉或玉米澱粉、葡萄糖聚合物、玉米糖漿、玉米糖漿固體、源自稻之碳水化合物、源自豌豆之碳水化合物、源自馬鈴薯之碳水化合物、木薯澱粉、蔗糖、葡萄糖、果糖、乳糖、高果糖玉米糖漿、蜂蜜、糖醇(例如麥芽糖醇、赤藻糖醇、山梨糖醇)、人工甜味劑(例如蔗糖素、乙醯磺胺酸鉀、甜菊)及其組合。特別合乎需要之碳水化合物為低右旋糖當量(DE)之麥芽糊精。
本發明之營養組合物可另外包含其他視情況存在之組分,其可改良產品之物理、化學、美感或加工特徵,或當用於目標群體時用作醫藥或其他營養組分。許多該等視情況存在之成分為已知的或另外適用於醫療食品或其他營養產品或醫藥劑型中,且亦可用於本文之組合物中,其限制條件為該等視情況存在之成分對於經口投與為安全的且可與所選產品形式中之必需及其他成分相容。
該等視情況存在之成分的非限制性實例包括防腐劑、乳化劑、緩衝劑、核苷酸、果寡糖、纖維、半乳寡糖、聚右旋糖,及其他益菌助生質、益生菌、醫藥活性劑、消炎劑、如本文所述之其他養分、著色劑、調味劑、增稠劑及穩定劑、乳化劑、潤滑劑等。
營養組合物可另外包含甜味劑,較佳包括至少一種糖醇,諸如麥芽糖醇、赤藻糖醇、山梨糖醇、木糖醇、甘露糖醇、異麥芽糖醇及乳糖醇,且亦較佳包括至少一種人工或高效甜味劑,諸如乙醯磺胺酸鉀、阿斯巴甜糖(aspartame)、蔗糖素、糖精、甜菊及塔格糖(tagatose)。此等甜味劑,尤其是糖醇與人工甜味劑之組合,尤其適用於調配具有所要風味特徵之本發明之液體飲料實施例。此等甜味劑組合在掩蔽有時與向液體飲料添加植物蛋白質有關之非所要風味方面尤其有效。營養產品中視情況存在之糖醇濃度範圍以營養產品之重量計可為至少0.01%,包括約0.1%至約10%,且亦包括約1%至約6%。視情況存在之人工甜味劑濃度範圍以營養產品之重量計可為約0.01%,包括約0.05%至約5%,亦包括約0.1%至約1.0%。
如本文所述之營養組合物中可包括助流劑或抗結塊劑來延遲粉末隨時間之凝集或結塊且使粉末實施例容易自其容器流出。已知或另外適用於營養粉末或產品形式中之任何已知助流劑或抗結塊劑適用於本文中,其非限制性實例包括磷酸三鈣、矽酸鹽及其組合。營養組合物中助流劑或抗結塊劑之濃度取決於產品形式、其他所選成分、所要
流動特性等而變化,但最通常以營養組合物之重量計在約0.1%至約4%之範圍內,包括約0.5%至約2%。
營養組合物中亦可包括穩定劑。已知或另外適用於營養組合物中之任何穩定劑亦適用於本文中,其一些非限制性實例包括膠狀物,諸如三仙膠(xanthan gum)。穩定劑以營養組合物之重量計可佔約0.1%至約5.0%,包括約0.5%至約3%,包括約0.7%至約1.5%。
營養組合物可另外包含多種其他維生素或相關養分中之任一者,其非限制性實例包括維生素A、維生素D、維生素E、維生素K、硫胺素、核黃素、吡哆醇、維生素B12、類胡蘿蔔素(例如β-胡蘿蔔素、玉米黃素、葉黃素、番茄紅素)、菸酸、葉酸、泛酸、生物素、維生素C、膽鹼、肌醇、其鹽及衍生物,及其組合。食物產品較佳包括(但不限於)以下維生素及礦物質:鈣、磷、鈉、氯化物、鎂、錳、鐵、銅、鋅、硒、碘、鉻、鉬、條件必需養分m-肌醇、肉鹼及牛磺酸,以及維生素A、C、D、E、K及B複合物,及其混合物。
條件必需養分肉鹼為由甲硫胺酸及離胺酸形成的天然存在之胺基酸。其主要代謝作用與長鏈脂肪酸跨粒線體膜之運輸有關,因此刺激此等燃料物質氧化用於代謝能。肉鹼補充為諸如肝病及腎病,及伴發營養不良之嚴重慢性疾病或大面積損傷之病狀中的重要代謝工具。視情況,飲食替代物可補充有足以供應高達每天4gm肉鹼之含量的肉鹼。
營養組合物可另外包含多種其他額外礦物質中之任一者,其非限制性實例包括鈣、磷、鎂、鐵、鋅、錳、銅、鈉、鉀、鉬、鉻、氯化物及其組合。
飲食替代物亦可含有纖維及穩定劑。適合纖維及/或穩定劑來源包括(但不限於)三仙膠、瓜爾膠(guar gum)、***膠(gum arabic)、印度膠(gum ghatti)、刺梧桐膠(gum karaya)、黃蓍膠、瓊脂、富塞蘭
藻膠(furcellaran)、結冷膠(gellan gum)、刺槐豆膠、果膠、低甲氧基果膠及高甲氧基果膠、燕麥及大麥葡聚糖、角叉菜膠、車前子、明膠、微晶纖維素、CMC(羧甲基纖維素鈉)、甲基纖維素羥丙基甲基纖維素、羥丙基纖維素、DATEM(單酸甘油酯及二酸甘油酯之二乙醯基酒石酸酯)、聚葡萄糖、角叉菜膠、FOS(果寡糖)及其混合物。可溶性膳食纖維之眾多商業來源均為可獲得的。舉例而言,***膠、水解羧甲基纖維素、瓜爾膠、果膠以及低甲氧基果膠及高甲氧基果膠可購自TIC Gums,Inc.,Belcamp,Md。燕麥及大麥葡聚糖可購自Mountain Lake Specialty Ingredients,Inc.,Omaha,Nebr。車前子可購自Meer Corporation,North Bergen,N.J.,而角叉菜膠可購自FMC Corporation,Philadelphia,Pa。
併入之纖維亦可為不溶性膳食纖維,其代表性實例包括燕麥殼纖維、豌豆殼纖維、大豆殼纖維、大豆子葉纖維、甜菜纖維、纖維素及玉米麩。不溶性膳食纖維之眾多來源亦為可獲得的。舉例而言,玉米麩可購自Quaker Oats,Chicago,Ill.;燕麥殼纖維來自Canadian Harvest,Cambridge,Minn.;豌豆殼纖維來自Woodstone Foods,Winnipeg,Canada;大豆殼纖維及燕麥殼纖維來自The Fibrad Group,LaVale,Md.;大豆子葉纖維來自Protein Technologies International,St.Louis,Mo.;甜菜纖維來自Delta Fiber Foods,Minneapolis,Minn.,且纖維素來自the James River Corp.,Saddle Brook,N.J.。
纖維實例及其向食物產品中之併入的更詳細論述可見於頒予Garleb等人之美國專利第5,085,883號中。
配方中所用之纖維的量可變化。所用纖維之特定類型並不關鍵。可利用適於人類消費且在食物產品之基質中穩定的任何纖維。
除纖維之外,營養組合物亦可含有寡糖,諸如果寡糖(FOS)或葡寡糖(GOS)。寡糖可由存在於大腸中之厭氧微生物迅速且大規模醱酵
形成短鏈脂肪酸。此等寡糖為大多數雙叉桿菌屬(Bifidobacterium species)之較佳能量來源,但不為潛在病原微生物(諸如產氣莢膜梭菌(Clostridium perfingens)、艱難梭菌(C.difficile)或大腸桿菌(Eschericia coli))所利用。
營養產品可另外包含一或多種增稠劑(thickner/thickening agent)。添加增稠劑可藉由誘導飽腹感(如上文所論述,此延長胃通過時間)來降低感覺異常之發生率。
例示性增稠劑包括***膠、羧甲基纖維素鈉、甲基纖維素、瓜爾膠、結冷膠、刺槐豆膠、蒟蒻粉(konjac flour)、羥丙基甲基纖維素、黃蓍膠、刺梧桐膠、***膠、聚葡萄胺糖、***半乳聚糖、葡甘聚醣、三仙膠、海藻酸鹽、果膠、低甲氧基果膠及高甲氧基果膠、穀類β-葡聚糖(亦即,燕麥β-葡聚糖、大麥β-葡聚糖)、角叉菜膠及車前子。
用於營養液中之一種尤佳增稠劑為結冷膠。結冷膠為由多沼假單胞菌(Pseudomonas elodea)產生之水溶性多糖。因為結冷膠為剪切稀化的,所以其可用於營養液中而不產生無吸引力之黏性變形產品。尤佳用於本發明之營養產品中者包括低醯基結冷膠。「低醯基」結冷膠(亦稱為且常稱為去醯化結冷膠)意謂結冷膠已經處理,使得其形成堅固、無彈性之脆性凝膠,相較於形成軟質、彈性極大之無脆性凝膠之「高醯基」,其為熱穩定的。一種適合的市售低醯基結冷膠為Kelcogel F(CP Kelco U.S.Inc.,Atlanta Georgia)。
增稠劑,且尤其是結冷膠,係以營養液重量計在約0.03%至約0.05%範圍內,包括約0.035%至約0.045%且包括約0.04%之濃度存在於營養液中。
本發明之粉末狀營養組合物中脂肪、碳水化合物及蛋白質之總量或總濃度可取決於所選組合物及預期使用者之膳食或醫學需求而顯
著變化。下文闡述了大量營養素濃度之其他適合實例。
本發明之營養組合物可以任何已知或另外適合之口服產品形式調配及投與。任何固體、液體、半固體及半液體或粉末產物形式,包括其組合或變化形式,均適用於本文中,其限制條件為該等形式允許將必需成分(亦如本文所定義)安全且有效地經口遞送至個體。
營養組合物可為包含本文所述成分且經口投與安全且有效之任何產品形式。營養組合物可調配成僅包括本文所述之成分,或可經視情況存在之成分改質以形成許多不同的產品形式。
本發明之營養組合物合意地調配成膳食產品形式,其在本文中定義為包含本發明之成分的彼等實施例,其為含有脂肪、蛋白質及碳水化合物中至少一者且較佳亦含有維生素、礦物質或其組合的產品形式。營養組合物將至少包含中性或酸性HMO,其合意地與蛋白質、脂肪、維生素及礦物質中至少一者組合,產生營養組合物。
營養組合物可用足夠種類及量之養分調配,以提供唯一、主要或補充營養來源,或提供用於罹患特定疾病或病狀之個體或具有如下文所述之目標營養益處的專門營養產品。
適用於本文中之營養組合物形式之實例包括零食及飲食替代產品,包括調配成條、棒、小甜餅或麵包或蛋糕或其他烘焙物品、冷凍液、糖果、早餐穀類食品、粉末或顆粒狀固體或其他微粒、零食碎片(chip)或口嚼片(bite)、冷凍或殺菌袋裝主菜等產品。營養組合物亦可為介於固體與液體之間的形式,諸如半固體或半液體組合物,諸如布丁狀物或凝膠。
適用於本文中之液體產品形式之實例包括零食及飲食替代產品、熱飲料或冷飲料、碳酸飲料或非碳酸飲料、果汁或其他酸化飲料、乳品或基於大豆之飲料、奶昔、咖啡、茶、藉由鼻飼插管投與之
組合物等。此等液體組合物最通常調配成懸浮液或乳液,但亦可調配成任何其他適合形式,諸如澄清液體、實質上澄清之液體、液體凝膠等。
營養組合物包括一或多種幫助滿足患者之營養要求之成分。視情況存在之養分每份或每劑可提供高達約1000kcal能量,包括約25至約900kcal、約75至約700kcal、約150至約500kcal、約350至約500kcal或約200至約300kcal能量。
大多數飲食替代產品(亦即,條或液體)由脂肪、碳水化合物及蛋白質提供卡路里(calory)。此等產品通常亦含有維生素及礦物質,因為預期其可適用作唯一營養來源。儘管此等飲食替代產品可用作唯一營養來源,但其通常不會如此。個體消費此等產品來替代每天的一餐或兩餐,或提供健康零食。本發明之營養產品應理解為包括此等實施例中任一者。
此等營養成分之量可取決於目標患者群體(亦即,癌症、HIV/AIDS、關節炎、感官考慮、文化偏好、使用等)而廣泛變化。然而,作為通用非限制性準則,本發明之飲食替代產品將含有以下相對量之蛋白質、脂肪及碳水化合物(以總卡路里之相對百分比計):提供佔總卡路里含量5至80%之蛋白質組分、提供佔總卡路里含量10至70%之碳水化合物組分,及提供佔總卡路里含量5至50%之脂質組分。
如熟習製備營養配方技術者已知的,飲食替代物將含有適合碳水化合物、脂質及蛋白質。適合碳水化合物包括(但不限於)來源於玉米、木薯澱粉、稻或馬鈴薯的呈蠟狀或非蠟狀形式之水解澱粉、完整澱粉、天然澱粉及/或化學改質澱粉;及糖,諸如葡萄糖、果糖、乳糖、蔗糖、麥芽糖、高果糖玉米糖漿、玉米糖漿固體、果寡糖,及其混合物。
通常,FOS佔每份飲食替代物0至5gm,較佳每份飲食替代物1至
5gm,更佳每份飲食替代物2至4gm。
飲食替代物可使用熟習此項技術者熟知的技術製造。存在多種加工技術。此等技術通常包括由一或多種溶液形成漿料,其可含有水及以下一或多者:碳水化合物、蛋白質、脂質、穩定劑、維生素及礦物質。中性或酸性HMO通常在其他礦物質之前添加至碳水化合物漿料中。該漿料經乳化、均質化並冷卻。可在加工之前、加工之後或加工之前及加工之後向漿料中添加多種其他溶液。經加工配方接著經滅菌且可經稀釋以乾燥成粉末,即食使用或以濃縮液形式封裝。當所得配方欲為即食液體或濃縮液時,在滅菌之前將添加適量水。
諸如條、小甜餅等之固體組合物亦可利用熟習此項技術者已知之技術製造。舉例而言,其可使用如此項技術中已知之冷擠壓技術製造。為了製備該等組合物,通常將所有粉末狀組分乾式摻合在一起。該等組分通常包括蛋白質、維生素預混物、某些碳水化合物等。接著將脂溶性組分摻合在一起且與上述粉末狀預混物混合。最後,將任何液體組分混合於組合物中,形成塑膠樣組合物或黏團。
上述方法欲產生塑性體,其接著可藉由稱為冷成形或擠壓之程序成形,而不進一步發生物理或化學改變。在此方法中,塑性體在相對較低壓力下強制通過可賦予所要形狀之模具。所得擠出物接著在適當位置切斷以產生所要重量之產品。需要時,接著塗覆固體產品以提高可口性,且封裝以供分配。通常,封裝將向最終消費者提供使用說明(亦即,可由癌症患者消費,幫助使瘦肉損失降至最少,等等)。
本發明之固體組合物亦可藉由烘焙應用或熱擠壓製造,產生穀類、小甜餅及脆餅乾。熟習此項技術者將能夠自可用於產生所要最終產品之許多製造方法中選出一種。
如上文所述,中性或酸性HMO亦可併入果汁、非碳酸飲料、碳酸飲料、電解質溶液、加味水(下文統稱為「飲料」)等。此項技術中
熟知用於製造該等飲料之方法。讀者注意力貫注於美國專利5,792,502,其各自之內容以引用的方式併入本文中。舉例而言,包括中性或酸性HMO在內之所有成分均溶解於適當體積之水中。接著視情況添加調味劑、著色劑、維生素等。接著混合物經巴氏殺菌(pasteurize),封裝並儲存直至出貨。
適用於如本文所揭示之含有中性或酸性HMO之組合物的產品形式之具體非限制性實例包括例如液體及粉末狀膳食補充劑。
營養液包括濃縮營養液及即食營養液兩者。此等營養液最通常調配成懸浮液或乳液,不過其他液體形式亦在本發明之範疇內。通常,中性或酸性HMO可併入飲食替代飲料中,諸如Ensure®、Glucerna®等。中性或酸性HMO亦可併入EAS液體運動營養產品中。或者,中性或酸性HMO可併入果汁、碳酸飲料、瓶裝水等中。此外,中性或酸性HMO可併入諸如ProSure®、Promote®、Jevity®及Advera®之醫療營養品中,其經設計以支持特定疾病病況,諸如癌症、HIV/AIDS、COPD關節炎等。熟習此項技術者熟知用於製造該等食物產品中任一者之方法。
當營養產品為濃縮營養液時,濃縮營養液中之中性或酸性HMO總濃度為約0.0002%至約0.60%,包括約0.002%至約0.30%,包括約0.02%至約0.20%,且進一步包括約0.02%至約0.06%(以濃縮營養液之重量計)。
當營養產品為即食營養液時,即食營養液中之中性或酸性HMO總濃度為約0.0001%至約0.50%,包括約0.001%至約0.15%,包括約0.01%至約0.10%,且進一步包括約0.01%至約0.03%(以即食營養液之重量計)。
適用之營養乳液可為包含蛋白質、脂肪及碳水化合物之水性乳
液。此等乳液一般為在約1℃至約25℃下可流動或可飲用之液體且通常為水包油、油包水或複合水性乳液形式,不過該等乳液最通常為具有連續水相及不連續油相之水包油乳液形式。
營養乳液可為且通常為存放穩定的。營養乳液通常含有以營養乳液重量計至多約95%水(以重量計),包括約50%至約95%,亦包括約60%至約90%,且亦包括約70%至約85%水。營養乳液可具有多種產品密度,但最通常具有大於約1.03g/mL,包括大於約1.04g/mL,包括大於約1.055g/mL,包括約1.06g/mL至約1.12g/mL,且亦包括約1.085g/mL至約1.10g/mL之密度。
營養乳液可具有針對最終使用者之營養需求而定製之卡路里密度,不過在大多數情形中,乳液一般包含至少15kcal/fl oz(540kcal/l),更通常約27.5kcal/fl oz(928kcal/l)至約44kcal/fl oz(1475-1480kcal/l)。在一些實施例中,乳液可具有約500kcal/l至約3000kcal/l,包括約540kcal/l至約2000kcal/l的卡路里密度。在一些具體實施例中,乳液可具有500,或900,或1200,或1500,或2000kcal/l之卡路里密度。
營養乳液可具有約2.5至約8的pH值範圍,但最有利在約4.5至約7.5範圍內,包括約5.5至約7.3,包括約6.2至約7.2。
儘管營養乳液之食用分量可取決於多種變數而變化,但典型食用分量一般為至少約1mL,或甚至為至少約2mL,或甚至為至少約5mL,或甚至為至少約10mL,或甚至為至少約25mL,包括約1mL至約360mL範圍,包括約30mL至約250mL,且包括約60mL至約240mL。
較佳液體營養組合物包括Ensure® Muscle Health及Ensure® Clinical Strength,二者皆可購自Abbott Nutrition(Columbus,OH)。Ensure® Clinical Strength(Ensure® CS)之組合物的非限制性實例描述
於下表1及表2中,具體成分緊接其後提供。
在一具體實施例中,營養補充劑包括水、玉米糖漿、蔗糖、乳蛋白濃縮物、酪蛋白鈉、菜籽油、玉米油、果寡糖、大豆蛋白分離物、2'-海藻糖基乳糖、乳清蛋白濃縮物、檸檬酸鉀、天然及人工調味劑、磷酸鉀、卵磷脂、纖維素凝膠、氫氧化鎂、碳酸鈣、抗壞血酸、磷酸鈣、氯化膽鹼、氯化鈉、磷酸鈉、氫氧化鉀、硫酸鋅、纖維素膠、L-肉鹼、角叉菜膠、dl-α-生育酚乙酸酯、右旋糖、硫酸亞鐵、麥芽糊精、菸鹼醯胺、結冷膠、泛酸鈣、檸檬酸、硫酸銅、硫酸錳、氯化鉻、氯化硫胺素鹽酸鹽、椰子油、維生素A棕櫚酸酯吡哆醇鹽酸鹽、核黃素、葉酸、生物素、硒酸鈉、鉬酸鈉、碘化鉀、葉綠醌、氰鈷維生素及維生素D3。
營養固體可為任何固體形式,但通常為可流動或實質上可流動之微粒組合物,或至少微粒組合物形式。特別適合之營養固體產品形式包括噴霧乾燥、聚結及/或乾式摻合之粉末組合物。該等組合物容易挖取且用調羹或其他類似裝置量測,且預期使用者容易用適合水性液體(通常為水)將其復原形成供立即口服或經腸使用之營養組合物。在此情形中,「立即」使用一般意謂在約48小時內,最通常在約24小時內,較佳就在復原之後。
當營養產品為營養粉末時,營養粉末中以營養粉末之重量計的中性HMO總濃度為約0.0005%至約5%,包括約0.01%至約1%。
營養粉末可在使用之前用水復原成針對最終使用者之營養需求而定製之卡路里密度,不過在大多數情形中,粉末用水復原形成一般包含至少15kcal/fl oz(540kcal/l),更通常約27.5kcal/fl oz(928
kcal/l)至約44kcal/fl oz(1475-1480kcal/l)的組合物。在一些實施例中,乳液可具有約500kcal/l至約3000kcal/l,包括約540kcal/l至約2000kcal/l的卡路里密度。在一些具體實施例中,乳液可具有500,或900,或1200,或1500,或2000kcal/l之卡路里密度。
在另一實施例中,中性或酸性HMO可併入飲料、條、小甜餅等中,其經專門設計以增強中性或酸性HMO之可口性且增加替代形式之選擇,藉此增大患者/消費者之接受度。中性或酸性HMO可併入飲食替代物或零食條中,諸如Glucerna®條、ZonePerfect®條及EAS® Sports Nutrition條等。熟習此項技術者熟知用於製造該等食物產品中任一者之方法。以下論述欲說明該等食物產品及其製備。
若營養組合物以條形式提供,則營養條可包括每條約0.01mg至約10g,包括每條0.1mg至約10g,包括每條約0.01mg至小於2g,且包括每條約0.1mg至小於2g之量的至少一種中性人乳寡糖。
較佳條營養組合物包括Glucerna® Hunger Smart Bar、Glucerna® Snack Bar、Glucerna® Meal Replacement Bar、ZonePerfect® Bar、EAS® Lean 15TM Bar及EAS® Myoplex 30TM Bar,其均可購自Abbott Nutrition(Columbus,OH)。Glucerna® Hunger Smart Chocolate Chip Snack Bar之例示組合物描述於下表3中,具體成分緊接其後提供。
在本發明之一具體例示實施例中,上文所示之Glucerna® Hunger Smart Chocolate Chip Snack Bar包括:大豆蛋白脆片、巧克力味塗層之果汁及穀類糊精、蜀葵黏合劑、果糖液、巧克力味碎片、大豆蛋白分離物、玉米麥芽糊精、短鏈果寡糖、2-海藻糖基乳糖、甘油、高油酸紅花油及巧克力層。
本發明之營養組合物可藉由用於製備所選產品固體或液體形式之任何已知或另外的有效製造技術來製備。已知許多該等技術可用於任何既定產品形式(諸如營養液或粉末)且容易由一般技術人員應用於本文所述之營養組合物。
因此,本發明之營養組合物可藉由多種已知或另外有效調配或製造方法中之任一者製備。在一種適合製造方法中,例如製備至少三種獨立漿料,包括脂肪包蛋白質(PIF)漿料、碳水化合物-礦物質(CHO-MN)漿料及水包蛋白質(PIW)漿料。PIF漿料係藉由以下方式形成:加熱並混合油(例如菜籽油、玉米油等),接著在持續加熱及攪拌下添加乳化劑(例如卵磷脂)、脂溶性維生素,及全部蛋白質之一部分(例如乳蛋白濃縮物等)。CHO-MIN漿料係藉由在加熱攪拌下向水中添加以下物質來形成:礦物質(例如檸檬酸鉀、磷酸二鉀、檸檬酸鈉等)、痕量及超痕量礦物質(TM/UTM預混物)、增稠劑或懸浮劑(例如
晶性織維素、結冷膠、角叉菜膠)。所得CHO-MIN漿料在持續加熱及攪拌下保持10分鐘,隨後添加其他礦物質(例如氯化鉀、碳酸鎂、碘化鉀等),及/或碳水化合物(例如中性或酸性HMO、果寡糖、蔗糖、玉米糖漿等)。接著藉由在加熱及攪拌下混合剩餘蛋白質(若存在的話)來形成PIW漿料。
接著在加熱攪拌下將所得漿料摻合在一起且將pH值調整至6.6-7.0,此後對組合物進行高溫短時(HTST)加工,在此期間對組合物進行熱處理,乳化及均質化,接著使其冷卻。添加水溶性維生素及抗壞血酸,必要時將pH值調整至所要範圍,添加調味劑,且添加水以實現所要總固體含量。接著組合物經無菌封裝以形成經無菌封裝之營養乳液。此乳液接著可進一步稀釋,熱處理且封裝以形成即食或濃縮液,或其可經熱處理且隨後經加工且以可復原粉末(例如噴霧乾燥、乾式混合、聚結粉末)形式封裝。
營養固體(諸如噴霧乾燥之營養粉末或乾式混合之營養粉末)可藉由適於製備及調配營養粉末之任何已知或另外有效技術之集合來製備。
舉例而言,當營養粉末為噴霧乾燥之營養粉末時,噴霧乾燥步驟可同樣包括已知或另外適用於製造營養粉末之任何噴霧乾燥技術。已知許多不同噴霧乾燥方法及技術可用於營養領域中,其均適用於製造本文之噴霧乾燥之營養粉末。
一種製備噴霧乾燥之營養粉末之方法包含形成包含預消化脂肪及視情況存在之蛋白質、碳水化合物及其他脂肪來源之水性漿料或液體並進行均質化,接著對漿料或液體噴霧乾燥以產生噴霧乾燥之營養粉末。該方法可進一步包含噴霧乾燥、乾式混合或以其他方式向噴霧乾燥之營養粉末中添加其他營養成分(包括本文所述之成分中之任一種或多種)之步驟。
用於製備營養產品之其他適合方法描述於例如美國專利第6,365,218號(Borschel等人)、美國專利第6,589,576號(Borschel等人)、美國專利第6,306,908號(Carlson等人)、美國專利申請案20030118703 A1(Nguyen等人)中,其描述以引用的方式併入本文中達到與本文一致的程度。用於製備營養條之方法描述於美國專利6,248,375中,且描述以引用的方式併入本文中達到與本文一致的程度。
如本文所述之營養組合物可用於解決本文所論述之一或多種疾病或病狀,或可用於向成年及老年個體提供本文所述之一或多種益處。利用本文所述之營養組合物的成年或老年個體可實際上患有或罹患所述疾病或病狀,或可易患疾病或病狀,或處於患上疾病或病狀之風險中(亦即,可能尚未實際患上疾病或病狀,但由於某些條件(家族史等)而比一般群體患上疾病或病狀之風險高)。不管成年或老年個體是實際上患有疾病或病狀,還是處於疾病或病狀之風險中,抑或易患疾病或病狀,成年或老年個體在本文中分類為「需要」幫助處理並對抗疾病或病狀。舉例而言,成年或老年個體可例如由於家族史或其他醫學病況而實際上患有呼吸道炎症或可處於患上呼吸道炎症之風險中(易患上呼吸道炎症)。不管成年或老年個體是實際上患有疾病或病狀,還是僅處於患上疾病或病狀風險中,抑或易患疾病或病狀,用本文所述之營養組合物幫助成年或老年個體均在本發明之範疇內。
另外,單獨或與另一中性HMO(例如3FL)組合之2'FL適用於需要減輕炎症之兒科、成人產品及老年群體。有需要之群體包括:處於微生物感染(呼吸道或腸胃感染;敗血症;牙周炎)中;處於NEC風險中;處於血管炎症風險中;處於增加之PNC形成風險中(糖尿病婦女、局部缺血患者、活動性鐮狀細胞病);處於慢性炎症風險中(老年、過敏症/哮喘、IBD、NEC)。
基於上述,因為本發明之一些方法實施例係針對經鑑別個體之特定子組或子類(亦即,「需要」幫助解決本文所述之一或多種特定疾病或特定病狀之個體子組或子類),所以並非所有成年或老年個體將在針對某些疾病或病狀之如本文所述之成年或老年個體的子組或子類內。
如本文所述之營養組合物包含單獨或與一或多種其他組分組合之中性或酸性HMO以提供用於減輕炎症(諸如呼吸道炎症,例如呼吸道融合性病毒誘發之炎症;腸炎症;鼻咽炎症;及全身性炎症)之營養來源。
此外,在營養組合物中使用中性或酸性HMO可減少呼吸道病毒(例如RSV、2型人類副流行性感冒病毒及A型流感病毒)生長,且因此減少病毒誘發之上呼吸道感染。
使用本發明之營養組合物亦可用作免疫調節劑,藉此減輕成年及老年群體中由感染誘發之炎症,諸如呼吸道病毒誘發之感染,且尤其是RSV誘發之炎症,及其他感染介導之發炎疾病。
當與LCPUFA及/或抗氧化劑,且尤其類胡蘿蔔素組合使用時,一般HMO(且尤其酸性HMO)可降低氧化應力,氧化應力為氧化之生物分子(諸如脂質過氧化物及其代謝產物、蛋白質羰基及氧化破壞之DNA)產生及累積增加的代謝病狀。氧化應力之結果在非所要之代謝改變至炎症以及細胞及組織死亡範圍內。因此,藉由降低未經調控之炎症及氧化的發生率,使得對組織襯膜之破壞及細胞死亡減少,進一步降低了發炎疾病之發生率。
除了上文所論述之益處外,已發現包括中性或酸性HMO之營養產品可調節單核細胞來源之細胞激素的產生,甚至在病毒不存在下亦如此。此產生使得免疫力提高,進一步使微生物感染降至最少且減少病毒生長。在一個具體實例中,藉由投與本發明營養組合物產生之單
核細胞來源之細胞激素包括例如介白素-10、介白素-8、介白素-1α、介白素-1β、介白素-1ra及其組合。
在營養組合物中利用中性或酸性HMO的另一益處在於,已發現中性或酸性HMO調節IP-10產量,IP-10為在對病毒感染之發炎性反應中起重要作用之趨化因子。具體言之,兒童中RSV臨床感染嚴重程度與血清IP-10含量之間存在正相關。因此,IP-10信號減少,則RSV感染之嚴重程度降低。在一個具體實施例中,IP-10產量減少至未感染對照組中發現之程度。
與減少IP-10一起,已發現中性HMO可減少血小板-嗜中性白血球複合物(PNC)形成,該複合物存在於人類血液中且由至多25%未經刺激之嗜中性白血球組成。因為PNC以聚集物形式存在,所以其具有較強的起始發炎過程之能力且可增加反應性氧物質之產量。因此,PNC形成減少可導致氧化應力及炎症減輕。
以下實例說明本發明營養組合物之具體實施例、特徵或兩者。該等實例僅出於說明之目的給出且不應理解為對本發明之限制,因此在不悖離本發明之精神及範疇情況下,其許多變化為可能的。除非另外說明,否則所有例示量均為以組合物總重量計之重量百分比。
例示性組合物為根據本文所述製造方法製備的存放穩定之營養組合物,由此除非另外說明,否則每一例示性組合物包括無菌加工之實施例及殺菌釜封裝之實施例。
資料係使用活體外模擬PNC形成,以15分鐘之成分培育期產生。
圖1中所示之結果表明,濃度為125μg/mL之單獨2'FL,以及FL混合物(70% 2'FL:30% 3FL=87.5μg 2'FL /mL:37.5μg 3FL/mL)顯著
減少PNC形成。圖1中之資料(n=2-3名個體)出乎意料地顯示,單獨或作為FL混合物(70% 2'FL:30% 3FL=87.5μg 2'FL/mL:37.5μg 3FL/mL)之一部分的2'FL藉由減少PNC形成來減輕炎症。由於公開資訊指出彙集之中性HMO(其將包括2'FL及3FL)不會減少PNC形成,故此為出乎意料的。
資料亦顯示個別酸性HMO 3'SL及6'SL不會減少PNC形成;且唾液酸(SL)亦不會減少PNC形成。同樣,資料顯示唾液酸化/酸性HMO 3'SL及6'SL不會減少PNC形成。鑒於先前資料顯示彙集之酸性HMO減少PNC形成,此為出乎意料的。
當自此PNC實驗選擇之資料藉由如表4所示之供體及成分詳細描述時,發現2'FL減少所有3名測試個體中之PNC形成。亦證明,LNnT使3名測試個體中之2名的PNC形成減少。對於所有測試成分,測試濃度為125μg/mL。用測試成分或單獨培養基(ADP)培育細胞15分鐘。向每一試管中添加ADP(10μM)且培育15分鐘。單獨ADP不含測試成分。資料係以在測試條件中作為在ADP刺激下呈CD11b+CD42a+之彼等事件之百分比的CD11b+CD42a+%表示。2'FL及LNnT之平均反應顯示此等成分具有最低的CD11b+CD42a+%值,指示PNC形成之減少達到最大。
實例3說明包括HMO之本發明乳液,其成分列於下表中。除非另外說明,否則所有成分量以每約1000磅產品批料之磅數列出。
實例4說明包括HMO之本發明乳液,其成分列於下表中。除非另外說明,否則所有成分量以每約1000磅產品批料之磅數列出。
實例5說明包括HMO之本發明乳液,其成分列於下表中。除非另外說明,否則所有成分量以每約1000磅產品批料之磅數列出。
實例6說明包括HMO的本發明之實質上澄清之營養液,其成分列於下表中。此液體之pH值介於2.9與4.0之間且在約18個月之存放期內保持物理穩定。除非另外說明,否則所有成分量以每約1000磅產品批料之磅數列出。
實例7說明包括HMO的本發明之實質上澄清之營養液,其成分列於下表中。此液體之pH值介於2.9與4.0之間且在約18個月之存放期內保持物理穩定。除非另外說明,否則所有成分量以每約1000磅產品批
料之磅數列出。
儘管本發明詳細描述了若干實例及實施例,但該描述僅出於說明之目的給出且不應理解為對本發明之限制。在不悖離本發明之精神及範疇情況下,本文所述之實例及實施例的許多變化為可能的。
Claims (15)
- 一種營養組合物之用途,其係用於製造用以調節或減輕有需要之成年或老年個體之炎症的藥物,該營養組合物包含約0.001mg/mL至約25mg/mL濃度之至少一種中性人乳寡糖。
- 如請求項1之用途,其中該至少一種中性人乳寡糖係選自由以下組成之群:2'-海藻糖基乳糖及乳糖-N-新四糖(LNnT)及其組合。
- 如請求項1之用途,其中該至少一種人乳寡糖為約0.001mg/mL至約15mg/mL濃度之2'-海藻糖基乳糖。
- 如請求項1之用途,其中該至少一種人乳寡糖為2'-海藻糖基乳糖,且其中2'-海藻糖基乳糖係以約0.050mg/mL至約10mg/mL濃度存在。
- 如請求項1之用途,其中該至少一種人乳寡糖為2'-海藻糖基乳糖,且其中2'-海藻糖基乳糖係以約0.1mg/mL至約10mg/mL濃度存在。
- 如請求項1之用途,其中該至少一種人乳寡糖為乳糖-N-新四糖(LNnT),且其中LNnT係以約0.1mg/mL至約5mg/mL濃度存在。
- 如請求項2之用途,其中該營養組合物另外包含3-海藻糖基乳糖,其係以在約0.001mg/mL至約10mg/mL範圍內之濃度存在。
- 如請求項7之用途,其中該至少一種人乳寡糖為2'-海藻糖基乳糖。
- 如請求項1至8中任一項之用途,其中該組合物另外包含濃度不超過該營養組合物中總脂肪含量之約5%的長鏈聚不飽和脂肪酸。
- 如請求項1至8中任一項之用途,其中該組合物另外包含約0.001μg/mL至約10μg/mL濃度之類胡蘿蔔素。
- 如請求項1至8中任一項之用途,其中該組合物另外包含濃度在約0.001mg/mL至約10mg/mL範圍內之酸性人乳寡糖。
- 如請求項1至8中任一項之用途,其中該組合物為合成配方。
- 如請求項1至8中任一項之用途,其中該炎症為呼吸道病毒誘發之炎症。
- 一種營養組合物之用途,其係用於製造用以調節成年或老年個體之炎症的藥物,該組合物包含濃度在約0.001mg/mL至約10mg/mL範圍內之酸性人乳寡糖、濃度不超過該營養組合物中總脂肪含量之約5%的長鏈聚不飽和脂肪酸,及濃度為約0.001μg/mL至約10μg/mL之類胡蘿蔔素。
- 如請求項14之用途,其中該組合物為合成配方。
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