TWI492744B - 使用類胡蘿蔔素調節早產兒發炎症之方法 - Google Patents
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Description
本發明係關於一種早產兒用配方,其包含葉黃素、蕃茄紅素及β-胡蘿蔔素,及該早產兒用配方於調節早產兒炎症,如皮膚炎症中之用途。
膳食類胡蘿蔔素係水果及蔬菜中富含之脂溶性化合物。類胡蘿蔔素負責水果及蔬菜中發現之顏色頻譜,且亦負責一些鳥類及貝類之體色。已證實有數百種類胡蘿蔔素化合物,且此等化合物中之約30種已於人血清、乳汁及其他組織中被檢測出(Khachik等人,「Chemistry,distribution,and metabolism of tomato carotenoids and their impact on human health」Exp. Biol. Med
. 2002,Vol. 227:845-851)。
人乳將各種抗氧化劑提供給接受母乳餵養之嬰兒。相反,除非將其他補充食品添加至膳食,否則僅接受配方餵養之嬰兒無法獲得接受母乳餵養之嬰兒所攝取類胡蘿蔔素之多樣性或量。接受配方餵養之嬰兒之膳食中缺乏類胡蘿蔔素會使早產兒產生特定問題。
於37週胎齡之前出生之嬰兒往往因早產而面臨併發症。例如,早產兒之罹病率較易增加,此點於健康足月嬰兒中並不常見。諸如肺、眼、腸及腦之未發育完成器官可導致諸如慢性肺病、支氣管發育不良(BPD)、早產兒視網膜病(ROP)、壞死性小腸結腸炎(NEC)及腦室出血(IVH)之病症。NICU中之嬰兒常具有增加之炎症及與常見的早產疾病及用於減輕此等疾病之治療有關之氧化壓力(Gitto等人,Am. J. Perinatol.
2004,Vol. 21:209-216;Ochoa,et al.,Free Rad. Res.
2003,Vol. 37:317-322;Saugstad,Sem. Neonatol.
2003,Vol. 3:39-49)。
早產兒於出生時亦出現營養不良,係因其等無法在懷孕之最後數周期間經歷營養素之最大轉移期。因此,需提供一種早產兒用配方,其包含充足量之類胡蘿蔔素,如葉黃素、蕃茄紅素及β-胡蘿蔔素,以調節早產兒發炎症,如與常見早產疾病有關之發炎症。
已出乎意料地發現早產兒發炎症,尤其皮膚發炎症,可藉由將以葉黃素、蕃茄紅素及β-胡蘿蔔素之混合物補充之早產兒用配方投與早產兒來調節。更特定言之,已發現含有特定量之β-胡蘿蔔素、葉黃素及蕃茄紅素之早產兒用配方可用於降低炎症標記物C-反應性蛋白質之血漿濃度,及進而減少早產兒炎症。
本發明係關於一種調節早產兒炎症之方法。該方法包括將包含約75 μg/L至約500 μg/L葉黃素、約60 μg/L至約500 μg/L蕃茄紅素及約85 μg/L至約500 μg/L β-胡蘿蔔素之早產兒用配方投與早產兒。
於另一態樣中,本發明係關於一種調節早產兒之C-反應性蛋白質濃度之方法。該方法包括將包含約75 μg/L至約500 μg/L葉黃素、約60 μg/L至約500 μg/L蕃茄紅素及約85 μg/L至約500 μg/L β-胡蘿蔔素之早產兒用配方投與早產兒。
已發現將含有特定量之類胡蘿蔔素,如β-胡蘿蔔素、葉黃素及蕃茄紅素之早產兒用配方投與早產兒時,會降低早產兒之C-反應性蛋白質之血漿濃度。由於C-反應性蛋白質係與發炎有關之習知標記物,故藉由降低早產兒之C-反應性蛋白質之血漿濃度,亦可調節發炎程度。
本發明係關於一種利用包含選擇量之類胡蘿蔔素:β-胡蘿蔔素、葉黃素及蕃茄紅素之早產兒用配方調節早產兒之C-反應性蛋白質,及進而調節發炎症之方法。更特定言之,已發現,當將含有選擇量之類胡蘿蔔素:β-胡蘿蔔素、葉黃素及蕃茄紅素之早產兒用配方投與早產兒時,嬰兒之C-反應性蛋白質之血漿濃度會降低。藉由降低C-反應性蛋白質之血漿濃度,可調節早產兒之發炎症程度。本發明之早產兒用配方及方法之此等及其他必需或視需要選用之元素或限制將詳細描述於下文中。
除非另外說明,否則如本文中所使用之術語「嬰兒」係指不超過約1歲大之兒童,且包括0至約4個月大之嬰兒、約4個月至約8個月大之嬰兒、約8個月至約12個月大之嬰兒、出生時小於2,500克之低初生體重嬰兒及早產兒。
除非另外說明,否則可於本文中交換使用之術語「早產兒」或「早熟嬰兒」係指於約37週胎齡前,一般於約26週至約34週胎齡之間出生之嬰兒。「足月」嬰兒係於約37至約42週胎齡之間出生之嬰兒。而就實際概念而言,胎齡可能無法準確確定,其可大概基於最後一次月經週期及/或其他客觀評估,如早期超音波評估或臨床新生兒評估,如Ballard法。於不同結果事件中選擇使用何種方法往往係醫師或機構之偏好問題。
術語「校正年齡」(CA)係指一種用於比較其等生長與發育之目的而將早產兒標準化至其等足月同齡兒之概念。校正年齡代表預產期出生之兒童年齡。校正年齡係以時齡減去40週胎齡前出生之週數計算。例如,提早8週出生之早產兒於約2個月之時齡時達到「足月校正年齡」,及於6個月時齡時可於發育學上相當於4個月大足月嬰兒。
術語「時齡」(或「出生後年齡」)係於出生(孕齡)後經過的時間。
術語「月經後年齡(post-menstrual age)」(PMA)係指最後一次月經期之第一日與出生之間經過之時間(孕齡)加上出生後經過之時間(時齡)。
除非另外說明,否則如本文中所使用之術語「早產兒用配方」係指針對早產兒設計含有足量營養素,如蛋白質、碳水化合物、脂質、維生素及礦物質以有利地用作補充、主要或唯一營養源之營養配方。
除非另外說明,否則如本文中所使用之術語「營養配方」係指針對嬰兒、學步幼兒、兒童、成人或其等組合設計,含有充足量之營養素,如蛋白質、碳水化合物、脂質、維生素、礦物質及電解質以有利地用作補充、主要或唯一營養源之營養組合物。
除非另外說明,否則術語「現成即食」係指適宜投與之呈液體形式之營養配方,包括復水粉末、經稀釋之濃縮液及人造液體。
除非另外說明,否則如本文中所使用之所有百分比、份數及比例係以總配方之重量計。除非另外說明,否則當與所列成份有關時,所有此等重量係基於活性物含量,且因此不包括包含於市售材料中之溶劑或副產物。
不論是否明確說明,如本文所使用之數值範圍欲包括彼範圍內之各數值及數值子集。此外,此等數值範圍應視為支持與彼範圍內任一數值或數值子集相關之主張。例如,1至10應視為包括2至8、3至7、5至6、1至9、3.6至4.6、3.5至9.9及諸如此類之範圍。
除非於所描述之內文中以語句明確或清晰說明,否者所有提及之本發明單數特徵或限制均應包括對應的複數特徵或限制,且反之亦然。
除非於所描述組合中以語句明確說明,否則如本文中所使用之方法或加工步驟之所有組合可依任何次序進行。
本發明之早產兒用配方亦可實質上不含本文中所描述之任何視需要選用或選擇之必需成份或特徵,條件係所得之配方仍含有如本文中所描述之全部所需成份或特徵。於本文中,除非另外說明,否則術語「實質上不含」意指所選擇配方中視需要選用之成份含量低於功能量,一般而言,低於0.1重量%,且亦包括0重量百分比之此視需要選用或選擇之必需成份。
本發明之早產兒用配方及其使用方法可包含如本文中所述之必需元素及限制,及本文中所述或其他可用於營養配方應用之任何額外或視需要選用之成份、組分或限制,或由其組成或基本上由其組成。
本發明之早產兒用配方包含類胡蘿蔔素:葉黃素、蕃茄紅素及β-胡蘿蔔素之選擇組合。如本文中所選擇及定義之含有此等組合之早產兒用配方可用於調節早產兒之發炎症及/或C-反應性蛋白質濃度。
一般而言,該早產兒用配方宜包含約75 μg/L至約500 μg/L葉黃素,包括約100 μg/L至約350 μg/L葉黃素,亦包括約200 μg/L至約250 μg/L葉黃素及約100 μg/L至約215 μg/L葉黃素。該早產兒用配方一般亦宜包含約60 μg/L至約500 μg/L蕃茄紅素,包括約90 μg/L至約350 μg/L蕃茄紅素,亦包括約100 μg/L至約150 μg/L蕃茄紅素。該早產兒用配方一般亦宜包含約85 μg/L至約500 μg/L β-胡蘿蔔素,包括約150 μg/L至約350 μg/L β-胡蘿蔔素,亦包括約200 μg/L至約250 μg/L β-胡蘿蔔素及約150 μg/L至約200 μg/L β-胡蘿蔔素。應理解本發明早產兒用配方中可包括此等量之β-胡蘿蔔素、葉黃素及蕃茄紅素之任何組合。於一個示例性實施例中,本發明之早產兒用配方包含約211 μg/L葉黃素、約143 μg/L蕃茄紅素及約219 μg/L β-胡蘿蔔素。於另一示例性實施例中,本發明之早產兒用配方包含約120 μg/L葉黃素、約100 μg/L蕃茄紅素及約180 μg/L β-胡蘿蔔素。如本文中所描述,早產兒用配方中可視需要包括其他類胡蘿蔔素。包括於本文所描述之早產兒用配方中之任何一種或所有類胡蘿蔔素可來自天然源或由人工合成。
於一項實施例中,該早產兒用配方可視需要進一步包含類胡蘿蔔素玉米黃質。本發明之早產兒用配方可包含約5 μg/L至約300 μg/L,包括約10 μg/L至約100 μg/L或約5 μg/L至約50 μg/L之玉米黃質。熟習本技藝者基於本揭示可瞭解,若使用天然來源之葉黃素,則類胡蘿蔔素中亦可包括一些玉米黃質。
一般而言,本發明之早產兒用配方包含充足量之葉黃素、蕃茄紅素及β-胡蘿蔔素,以提供約22 μg/kg/日至約150 μg/kg/日之葉黃素;約18 μg/kg/日至約150 μg/kg/日之蕃茄紅素;及約26 μg/kg/日至約150 μg/kg/日之β-胡蘿蔔素。視需要,該早產兒用配方可進一步包含充足量之玉米黃質,以提供約1 μg/kg/日至約15 μg/kg/日。
所選擇組合中之各類胡蘿蔔素可自用於營養配方中之任何已知或其他適宜材料來源獲得,且可單獨或全部一起,或以任何組合形式及自任何數量之來源提供,包括諸如含有其他維生素或礦物質而與本文中所述之類胡蘿蔔素中之一或多者組合成之綜合維他命預混合物之來源。葉黃素、蕃茄紅素、β-胡蘿蔔素或其等組合之一些適宜來源之非限制性實例包括LycoVit蕃茄紅素(自BASF,Mount Olive,NJ獲得)、呈油、粉末或珠粒形式之Lyc-O-Mato蕃茄提取物(自LycoRed Corp.,Orange,NJ獲得)、自DSM Nutritional Products,Parsippany,NJ獲得之β-胡蘿蔔素、葉黃素或蕃茄紅素、FloraGLO葉黃素(自Kemin Health,Des Moines,Iowa獲得)、Xangold天然葉黃素酯(自Cognis,Cincinnati,Ohio獲得)及Lucarotinβ-胡蘿蔔素(自BASF,Mount Olive,N.J獲得)。
可利用任何適宜技術測定類胡蘿蔔素血漿濃度。例如,可由血液樣品接受高效液相層析(HPLC)測定類胡蘿蔔素血漿濃度。可利用任何適宜技術,如拉曼(Raman)光譜法測定皮膚中之類胡蘿蔔素濃度。拉曼光譜法包括使皮膚曝露於雷射光源,及以光子頻率為函數檢測散射光。
可將本發明之早產兒用配方併入供人類嬰兒,尤其早產兒,或成人或動物食用之任何食品或飲品中。因此,於一態樣中,本發明係關於一種早產兒用配方。本發明之早產兒用配方可包含充足類型及含量之營養素,以滿足計畫使用者之目標膳食需求。因此,除上述類胡蘿蔔素外,此等早產兒用配方亦可包含蛋白質、碳水化合物及脂質組分(均可為有機或無機物)。該等早產兒用配方亦可包含維生素、礦物質或適宜用於早產兒用配方中之其他成份。
例如,該早產兒用配方包括之彼等實施例為其中蛋白質組分可占該配方之約7.5%至約25%卡路里含量;碳水化合物組分可占該配方之約35%至約50%總卡路里含量;及脂質組分可占該配方之約30%至約60%總卡路里含量。此等範圍僅供舉例說明,且無意限制。其他適宜範圍示於下表中。
已知碳水化合物、脂質、蛋白質、礦物質及維生素之許多不同來源及類型,且其等可用於本發明之早產兒用配方中,條件係此等營養素應與所選擇之配方中添加之成份相容,對所計畫之用途安全,且不會以其他方式過度影響產品性能。
適宜用於本發明之早產兒用配方中之碳水化合物可為簡單、複雜或變體或其等組合。適宜碳水化合物之非限制性實例包括經水解、完整、經天然及/或化學改質之玉米澱粉、麥芽糊精、葡萄糖聚合物、蔗糖、玉米糖漿、玉米糖漿固體、米或馬鈴薯產生之碳水化合物、葡萄糖、果糖、乳糖、高乳糖玉米糖漿及諸如果寡糖(FOS)之不可消化寡糖,及其組合。
適宜用於該早產兒用配方中之蛋白質之非限制性實例包括經高度水解、部份水解或未經水解之蛋白質或蛋白質源,且可衍生自任何已知或其他適宜來源,如乳類(例如,酪蛋白、乳清)、動物(例如,肉、魚)、穀類(例如,米、玉米)、蔬菜(例如,大豆),或其組合獲得。本文中所使用之蛋白質亦可包括(或完全或部份改用)已知用於嬰兒配方中之游離胺基酸,其等非限制性實例包括色胺酸、穀胺醯胺、酪胺酸、甲硫胺酸、半胱胺酸、精胺酸及其組合。一般而言,添加至嬰兒用配方之其他(非蛋白質)胺基酸包括肉毒鹼及牛磺酸。於一些例子中,將胺基酸之D-形式視為營養學上等同L-形式,且使用異構體混合物,以降低成本(例如,D,L-甲硫胺酸)。
適宜用於該等早產兒配方中之脂質之非限制性實例包括椰子油、大豆油、玉米油、橄欖油、紅花油、高油酸紅花油、MCT油(中鏈三酸甘油酯)、葵花油、高油酸葵花油、棕櫚油及棕櫚仁油、棕櫚油精、芥花油、水產動物油、棉籽油、諸如花生四烯酸(ARA)、二十二碳六烯酸(DHA)及二十碳五烯酸(EPA)之長鏈多不飽和脂肪酸,及其組合。
若需要,除此等食品級油類外,亦可將結構脂質併入該等早產兒用配方中。結構脂質係相關技藝已知,其等描述可參見INFORM,Vol. 8,no. 10,page 1004,Structured lipids allow fat tailoring(1997年10月)。結構脂質主要係於相同甘油核心上含有中鏈及長鏈脂肪酸之混合物之三醯基甘油。結構脂質亦描述於美國專利案第6,160,007號中,該案係以引用之方式併入本文。
除上述組分外,本發明之早產兒用配方可進一步包含任一種維生素。維生素之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、吡多素、維生素B12、菸鹼酸、葉酸、泛酸、生物素、維生素C、膽鹼、鉻、肉毒鹼、肌醇、其鹽及衍生物,及其組合。
該等早產兒用配方可進一步包含任一種礦物質,其非限制性實例包括鈣、磷、鎂、鐵、鋅、錳、銅、碘、鈉、鉀、氯化物及其等組合。
本發明之早產兒用配方較佳包含針對目標消費者或使用族群之相關嬰兒用配方指南所提及之營養素,例如:Infant Formula Act,21 U.S.C. Section 350(a)。
本發明之早產兒用配方包括含有表1(營養配方大量營養素)中所述之碳水化合物、脂質及蛋白質濃度之彼等實施例。
本發明之早產兒用配方包括之彼等實施例中,每100 kcal復水配方包含以下一或多者:維生素A(約250至約1250 IU)、維生素D(約40至約150 IU)、維生素K(大於約4 mcg)、維生素E(至少約0.3 IU)、維生素C(至少約8 mg)、硫胺素(至少約8 mcg)、維生素B12(至少約0.15 mcg)、菸鹼酸(至少約250 mcg)、葉酸(至少約4 mcg)、泛酸(至少約300 mcg)、生物素(至少約1.5 mcg)、膽鹼(至少約7 mg)及肌醇(至少約4 mg)。
本發明之早產兒用配方包括之彼等實施例中,每100 kcal復水配方包含以下一或多者:鈣(至少約50 mg)、磷(至少約25 mg)、鎂(至少約6 mg)、鐵(至少約0.15 mg)、碘(至少約5 mcg)、鋅(至少約0.5 mg)、銅(至少約60 mcg)、錳(至少約5 mcg)、鈉(約20至約60 mg)、鉀(約80至約200 mg)及氯化物(約55至約150 mg)。
本發明之早產兒用配方可進一步包含其他視需要選用之組分,其可修飾配方之物理、化學、美學或加工特性,或用作針對目標族群使用之醫藥或額外營養組分。許多此等視需要選用之成份係已知或其他適用於食品及營養產品(包括嬰兒用配方)之成份,且亦可用於本發明之早產兒用配方中,條件係此等視需要材料應可與本文中所述之必需材料相容,對其計畫用途為安全,且不以其他方式過度影響產品性能。
此等視需要選用之成份之非限制性實例包括防腐劑、抗氧化劑、乳化劑、緩衝劑、著色劑、調味劑、核苷酸及核苷、其他益生菌、其他益菌助生質、乳鐵蛋白及相關衍生物、增稠劑及穩定劑等。
可將本發明之早產兒用配方製備成適宜用於人類之任何產品形式,包括液體或粉末型完整營養物、液體或粉末型補充劑(如可與飲品混合之補充劑)、可復水粉末、現成即食液體、棒狀條及可稀釋液體濃縮物,所有產品形式均為營養配方技藝中所熟知。
本發明之早產兒用配方可具有適合目標或計畫病患族群(即早產兒)之任何卡路里密度,或於粉末實施例復水時或稀釋液體濃縮物實施例時提供此密度。關於本發明之配方最常見之卡路里密度一般為至少約19 kcal/fl oz(660 kcal/升),更一般為約20 kcal/fl oz(675至680 kcal/升)至約31 kcal/fl oz,甚至更一般為約20 kcal/fl oz(675至680 kcal/升)至約24 kcal/fl oz(800至810 kcal/升)。一般而言,更常見地將22至24 kcal/fl oz配方用於早產或低初生體重嬰兒,及更常見將20至21 kcal/fl oz(675至680至700 kcal/升)配方用於足月嬰兒。
就本發明之營養粉末實施例而言,此等粉末一般係呈可流動或實質上可流動顆粒組合物,或至少為顆粒組合物之形式,其等很容易藉由湯匙或類似的其他裝置舀起並量取,其中該等組合物可由計畫使用者利用適宜水性流體(一般為水)復原,形成用於即時口服或經腸用之液體營養配方。於本文中,「即時」使用一般意指於約48小時內,最常見係於24小時內,較佳在復水後立即使用。此等粉末實施例包括噴霧乾燥、聚結、乾式混合或其他已知或其他有效之顆粒形式。可改變製成適宜一次食用之體積時所需之營養粉末之量。
可將本發明之早產兒用配方包裝及密封於單次或多次使用容器中,及隨後於周圍條件下保存至多約36個月或更長,更一般約12至約24個月。就多次使用容器而言,此等包裝可由最終使用者打開並隨後封蓋重複使用,條件係將經封蓋之包裝保存於周圍條件下(例如,避免極端溫度)且於約一個月內使用內容物。
可由適宜製造及調配營養配方或類似的其他配方之任何已知或其他有效技術製備本發明之早產兒用配方,該等技術之變化可視諸如所選擇之產品形式、成份組合、包裝及容器選擇等用於所需早產兒用配方之變數而定。此等技術及針對任何指定配方之變化可藉由熟習營養調配或製造技藝者輕易確定及應用。
因此,本發明之早產兒用配方,包括下文所述之示例性配方,可藉由各種已知或其他有效的調配或製造方法製備。此等方法最常包括先形成含有碳水化合物、蛋白質、脂質、穩定劑或其他調配助劑、維生素、礦物質或其組合之水性漿液。該漿液經過乳化、巴斯德滅菌、均質化及冷卻。可於進一步加工之前、期間或之後將各種其他溶液、混合物或其他材料添加至所得乳液。隨後可進一步稀釋、熱處理及封裝此乳液形成現成即食或濃縮液體,或可使其經由熱處理及隨後加工並封裝成可復水粉末,例如,噴霧乾燥物、乾式混合物、聚結物。
製造營養配方之其他適宜方法係描述於,例如,美國專利案第6,365,218號(Borschel等人)、美國專利案第6,589,576號(Borschel等人)、美國專利案第6,306,908(Carlson等人)、美國專利申請案20030118703 A1(Nguyen等人),該等案係以引用之方式併入本文。
可將本發明之早產兒用配方作為營養源,以例如:營養配方之方式投與任何個體,尤其嬰兒,或更特定言之,早產兒。
本發明之早產兒用配方亦可用於調節C-反應性蛋白質(CRP)之濃度,進而調節個體,及特定言之,早產兒之炎症。特定言之,已知CRP為炎症之標記物。就人類而言,CRP濃度會因感染、創傷、手術及組織梗塞而提高。早產兒常出現炎症增加,及與常見的早產疾病有關之氧化壓力,如,尤其,慢性肺病、支氣管肺發育不良(BPD)、早產兒視網膜病(ROP)、壞死性小腸結腸炎(NEC)、及腦室出血(IVH)。早產兒之皮膚亦未發育完全且易於發炎。與早產有關之此等問題會增加早產兒之CRP濃度。
現已發現將含有文中所述濃度之β-胡蘿蔔素、葉黃素及蕃茄紅素之早產兒用配方投與早產兒,可調節該早產兒之CRP濃度。更特定言之,當將本發明之配方投與早產兒時,可降低該早產兒之CRP血漿濃度。由於CRP係炎症之習知標記物,故藉由降低早產兒之CPR血漿濃度亦可調節(即,減少)炎症。
因此,於一態樣中,本發明係關於一種調節早產兒炎症之方法。該方法包括將有效量之本發明早產兒用配方投與早產兒。調節炎症可為,例如,減少發炎,較佳為皮膚發炎,如,測定早產兒之CRP血漿濃度之降低程度。CRP血漿濃度可藉由標準血液CRP測試測定。
於另一態樣中,本發明係關於一種調節早產兒之CRP濃度之方法。該方法包括將有效量之本發明早產兒用配方投與早產兒。CRP濃度之調節法可為例如,降低早產兒之CRP血漿濃度。較佳,投與該早產兒用配方亦可提高早產兒皮膚中之β-胡蘿蔔素、葉黃素及蕃茄紅素濃度。
「有效量」之早產兒用配方係可使早產兒之炎症及/或CRP濃度有效達到所需降低程度之任何量。一般而言,將約100 mL/日至約1000 mL/日,更一般而言,約150 mL/日至約700 mL/日之量之早產兒用配方投與早產兒。較佳,投與充足量之早產兒用配方,以提供約22 μg/kg/日至約150 μg/kg/日之葉黃素;約18 μg/kg/日至約150 μg/kg/日之蕃茄紅素;及約26 μg/kg/日至約150 μg/kg/日之β-胡蘿蔔素。
就早產兒而言,可於需要調節早產兒之炎症及/或CRP濃度之任何時間投與該配方。一般而言,自經腸餵食開始投與直至一般約50週月經後年齡,或直至約40週月經後年齡。較佳,投與該早產兒用配方,至少直至早產兒之CRP血漿濃度降低及/或直至皮膚中之β-胡蘿蔔素、葉黃素及/或蕃茄紅素濃度升高。
以下實例進一步描述及證明本發明範圍內之具體實施例。該等實例僅針對說明之目的,不應視為對本發明之限制,因為可於不脫離本發明之精神及範圍下實施其許多變化。除非另外說明,否則所有描述之量均係基於組合物之總重量之重量百分比。
將所例舉之各配方餵與人類,以提供唯一、主要或補充營養。各配方含有如本文中所述之類胡蘿蔔素,且可用於調節早產兒之炎症及/或C-反應性蛋白質濃度。
以下實例說明本發明之早產兒用配方,包括製造及使用該等早產兒用配方之方法。關於各批料之配方成份列於表2中。當製備現成即食(RTF)配方時,各配方所提供之β-胡蘿蔔素、葉黃素及蕃茄紅素之實例量描述於表3及4中,其等可依用於製備RTF配方之水量而定。
可藉由製造至少兩種不同漿液,並隨後摻合於一起,經過熱處理、標準化、第二次熱處理、噴霧乾燥、聚結、乾式摻合及封裝,將所描述之配方製成粉末型營養嬰兒配方,或藉由製造至少兩種不同漿液,隨後摻合一起,經過熱處理、標準化、以適宜量的水稀釋、封裝及滅菌,製成液態現成即食嬰兒營養配方。開始時,由碳水化合物溶於60至71℃之水中,接著添加氯化鎂、氯膽鹼、氯化鈉、氯化鉀及碳酸鈣,製備碳水化合物-礦物質漿液。將所得之漿液維持於49至60℃之溫和攪拌下,直至其隨後與其他製得之漿液摻合。
在49至60℃下組合中鏈三酸甘油酯、單酸甘油酯、大豆油、椰子油、花生油酸及二十二碳六烯酸(DHA),接著添加類胡蘿蔔素(β-胡蘿蔔素、葉黃素、蕃茄紅素)、維生素A、維生素ADEK預混合物及卵磷脂,製成油漿液。將所得之油漿液維持於38至49℃之溫和攪拌下,直至其隨後與其他製得之漿液摻合。
藉由將脫脂奶粉及乳清蛋白濃縮物溶於約5至30℃之水中,製成蛋白質漿液。將所得之蛋白質漿液維持於2至7℃之低攪拌下,直至其隨後與其他製得之漿液摻合。
於適度攪拌下組合水、碳水化合物-礦物質漿液及蛋白質漿液。隨後添加油漿液。藉由氫氧化鉀,調節所得摻合物之pH。將此摻合物維持於49至60℃之溫和攪拌下。
將所得之摻合物加熱至71至77℃,乳化至300 psig最大值,及隨後於2400至2600/400至600 psig下均質化。隨後將該摻合物加熱至144至146℃後維持5秒鐘。隨後將經過加熱之摻合物冷卻至約4℃之溫度。取樣進行微生物及分析測試。將該混合物維持於攪拌下。
分開製備維生素/礦物質/牛磺酸預混合溶液及抗壞血酸溶液,並添加至經加工之摻合漿液。藉由攪拌下添加下列成份至水中,製備維生素/礦物質/牛磺酸預混合溶液:檸檬酸鉀、檸檬酸鈉、磷酸鉀、超微粉化磷酸三鈣、硫酸亞鐵、維生素/礦物質/牛磺酸預混合物、L-肉毒鹼及核苷酸-膽鹼預混合物。添加氫氧化鈉及抗壞血酸至足以溶解該等成份之水量中,製成抗壞血酸溶液。隨後以氫氧化鉀將該抗壞血酸溶液pH調節至5至9。
為製備粉末型營養嬰兒用配方,可使用氫氧化鉀調節摻合物pH,獲得最佳產品穩定性。摻合物隨後進行第二次熱處理。開始時,將該摻合物加熱至71至77℃,及隨後進一步加熱至144至146℃維持約5秒鐘。隨後使經加熱之摻合物通過快速冷卻器,將溫度降低至71至82℃。於熱處理後,蒸發該摻合物。
使經蒸發之摻合物通過噴霧乾燥器。隨後使加工後之粉末與水聚結成黏結劑溶液。將益生菌乾式摻合至該產物中。隨後將所得之產物封裝至適宜容器中。
為製備現成即食營養嬰兒配方,根據定量控制測試之分析結果,於攪拌下添加適量水至批料中,以獲得所需總固體。可調節產物pH,以獲得最佳產物穩定性。隨後將所得產物置於適宜容器中,並進行最終滅菌。
隨後使用所得之配方作為補充、主要或唯一營養來源,提供給早產兒或其他適宜個體。
進行研究以評估接受混合有類胡蘿蔔素之早產兒用配方之療程餵養之早產兒之血漿中β-胡蘿蔔素、葉黃素及蕃茄紅素濃度,並與接受不添加類胡蘿蔔素之早產兒用配方之療程餵養之早產兒之血漿濃度及接受人乳(HM)餵養之早產兒對照組進行比較。亦將接受混合有類胡蘿蔔素之早產兒用配方餵養之早產兒之皮膚類胡蘿蔔素濃度與接受不添加類胡蘿蔔素之早產兒用配方餵養之早產兒及接受HM之早產兒進行比較。
該研究係隨機化、對照、雙盲、平行研究。有203位自出生至21日大之早產嬰兒參加研究。自開始經腸餵養至40週月經後年齡(PMA),將添加(研究配方)或不添加(對照配方)類胡蘿蔔素之住院配方(SimilacSpecial Careformula(SSC))投與接受配方餵養之嬰兒,除非嬰兒提早達到3.5 kg體重或直到住院時於醫學判斷不再需要較高卡路里配方時為止。此時,改為接受添加(研究配方)或不添加(對照配方)類胡蘿蔔素之相應出院後配方(SimilacNeoSureformula)餵養嬰兒,及投與該出院後配方直至50週PMA(10週校正年齡)。於整個研究中仍以相同餵養療程對待嬰兒。特定言之,接受投與添加有類胡蘿蔔素之住院配方之嬰兒改為接受添加有類胡蘿蔔素之出院後配方,而接受不添加類胡蘿蔔素之住院配方餵養之嬰兒改為接受不添加類胡蘿蔔素之出院後配方。於此研究中使用之配方組成描述於表5中。
將接受餵養配方之嬰兒隨機分配至對照組或研究配方組。亦隨機分配接受人乳餵養之嬰兒。若因一些原因以致人乳不足或母親於研究期間之任何時候選擇不以人乳餵養其嬰兒,則以登記時隨機分配之配方(即,對照或研究配方)補充餵養。若配方(即,隨機分配之對照或研究配方)佔住院期間經腸內攝取之總體積之60%或更多,則以適宜的配方受試者評估最初分配至人乳餵養之嬰兒。
於203位隨機受試者中,有143位完成該研究。於完成研究之此等受試者中,108位完成所分配之餵養研究。若受試者遵循所分配之研究餵養直到50週PMA,則將其等視為完成該研究。
針對接受添加有類胡蘿蔔素之配方(即,研究配方)之受試者,由受試者之配方實際食用量計算之葉黃素及β-胡蘿蔔素攝取量示於表6中。
自研究第1天、出院時、40週PMA及50週PMA時之受試者獲取血液樣品(住院時1.5 mL及出院後0.5 mL)。將血液樣品送至Craft Technologies(Wilson,NC)以測定葉黃素、蕃茄紅素、β-胡蘿蔔素及C-反應性蛋白質之血漿濃度。研究第1天、出院時及40及50週PMA時之可評估受試者之葉黃素、蕃茄紅素及β-胡蘿蔔素之血漿濃度示於表7至10中。研究第1天、出院時、及40及50週PMA時之C-反應性蛋白質之血漿濃度示於表11中。亦於住院及40及50週PMA時測定嬰兒(研究配方組、對照配方組及人乳餵養組)之生長,包括體重增加、身高增加及頭圍。若於分析時控制人乳攝取,在研究期間之任何時候,對照配方組與研究配方組之間無生長差異(數據未顯示)。
表7至11描述歸類為「可評估」之受試者之結果。關於所指定研究結果之評估分析包括於觀察結果時自根據餵養方式之受試者收集之數據。將受試者結果數據歸類為「可評估」之分析,直至研究期間發生一或多個排除事件。排除事件包括正確隨機化,但不正確配送所指定之配方、拒絕或未成功抽血、配方攝取之體積少於住院總體積之60%、及配方攝取之天數少於出院後研究期之60%。此外,若於住院期間受試者接受少於7天之研究配方、於住院期間受試者之NPO(即,不以口進食任何食物)總天數至少為10天、或於50週時,受試者在接受最後一次研究配方時退出研究超過7天,則將受試者自評估分析中移除。建立此等原則,以保證嬰兒於住院期間及出院後之研究期內接受可接受量之所指定配方(對照組或研究組)。
如表7至10所示,登記(研究第1天)時之蕃茄紅素及β-胡蘿蔔素之血漿濃度並無差異,然而於研究第1天時,研究組之間之葉黃素血漿濃度不同(SF>CF;p<0.01)。出院時,研究配方組(添加類胡蘿蔔素)中之葉黃素、蕃茄紅素及β-胡蘿蔔素之血漿濃度比對照配方組(不添加類胡蘿蔔素)顯著更高。出院時,研究配方組之嬰兒具有比對照組嬰兒顯著更高之平均葉黃素血漿濃度(6.96對0.82 μg/dL;p<0.0001)。類似地,出院時,研究配方組之嬰兒之平均蕃茄紅素血漿濃度比對照配方組顯著更高(4.41對0.33μg/dL;p<0.0001)。研究配方組之平均β-胡蘿蔔素血漿濃度亦比對照配方組顯著更高(4.79對0.74 μg/dL;p<0.0001)。
於40及50週PMA時,於可評價受試者中,研究配方(SF)組之平均葉黃素血漿濃度亦顯著高於對照配方(CF)組(分別為10.30 μg/dL>0.93 μg/dL,p<0.0001;7.68 μg/dL>1.83 μg/dL,p<0.0001)。於約10至13週大時,研究配方組之葉黃素血漿濃度比對照配方組之血漿濃度接近人乳餵養之嬰兒所報告之葉黃素血漿濃度(即,平均5.88 μg/dL;0.49至20.09 μg/dL之範圍)。
就可評估受試者而言,於40週及50週PMA時,研究配方組之蕃茄紅素及β-胡蘿蔔素血漿濃度顯著高於對照配方組(p<0.0001)。特定言之,研究配方組之平均蕃茄紅素血漿濃度於40及50週PMA時分別為7.93 μg/dL及10.78 μg/dL。相對地,對照配方組之平均蕃茄紅素血漿濃度於40及50週PMA時分別僅為0.31 μg/dL及0.32 μg/dL(視為不可檢測)。因此,研究配方組之蕃茄紅素血漿濃度比對照配方組之血漿濃度接近人乳餵養之嬰兒於約10至13週大時所報告之蕃茄紅素血漿濃度(即,平均10.85 μg/dL;0.3至23.13 μg/dL之範圍)。
就可評估受試者而言,研究配方組於40及50週PMA時之平均β-胡蘿蔔素血漿濃度分別為7.22 μg/dL及8.49 μg/dL。相對地,對照配方組於40及50週PMA時之平均β-胡蘿蔔素血漿濃度為0.83 μg/dL及4.52 μg/dL。因此,研究配方組之β-胡蘿蔔素血漿濃度比對照配方組之血漿濃度接近人乳餵養之嬰兒於約10至13週大時報告之蕃茄紅素血漿濃度(即,平均6.79 μg/dL;0.40至29.89 μg/dL之範圍)。
研究第1天、出院時及40及50週PMA時,接受研究配方(添加有類胡蘿蔔素)之可評估受試者之C-反應性蛋白質(CRP)血漿濃度示於表11中。
如表11所示,研究配方組於40週PMA時之CRP濃度比對照配方組顯著更低(p<0.001)。圖1係顯示對照配方組、研究配方組及接受人乳餵養之對照組於研究第1天至40週PMA期間之CRP濃度中間值之圖。如圖1所示,於研究第1天至40週PMA期間,研究配方組及接受餵養人乳組之CRP濃度會下降,而對照配方組會升高。
CRP評估之結果說明類胡蘿蔔素對調節早產兒發炎症具有重要作用,此點可能與投與嬰兒之類胡蘿蔔素之量有關。特定言之,研究配方組之CRP濃度相對於對照組下降之時期(即,研究第1天至40週PMA)係研究配方嬰兒接受住院研究配方之時期。如以上表5所示,住院研究配方(添加有類胡蘿蔔素之SimilacSpecial Care配方)含有比出院後研究配方(添加有類胡蘿蔔素之Neosure配方)高之類胡蘿蔔素濃度。40週PMA時(即,研究組嬰兒接受SimilacSpecial Care研究配方時)之總類胡蘿蔔素攝取量比50週PMA時(即,研究組嬰兒接受NeoSure研究配方時)之總類胡蘿蔔素攝取量至少高兩倍(參見表6)。
針對研究配方組中之可評估嬰兒,描繪CRP血漿濃度(參見表11)對葉黃素、蕃茄紅素及β-胡蘿蔔素之血漿濃度之圖。結果示於圖2至4中。如圖2至4所示,CRP血漿濃度隨葉黃素(圖2)、蕃茄紅素(圖3)及β-胡蘿蔔素(圖4)增加而下降,說明葉黃素、蕃茄紅素及β-胡蘿蔔素之血漿濃度分別與CRP血漿濃度成反比。
就葉黃素、蕃茄紅素及β-胡蘿蔔素之血漿濃度而言,研究配方與對照配方組之間存在一致的差異。特定言之,於出院時及40及50週PMA時,研究配方組之葉黃素、蕃茄紅素及β-胡蘿蔔素之血漿濃度一致地比對照配方組高。研究配方組之類胡蘿蔔素血漿濃度比對照組受試者之血漿濃度更接近接受人乳餵養之足月嬰兒所呈現者。研究配方組及對照配方組中之嬰兒均具有良好生長,說明兩種配方均提供適量營養給嬰兒且具良好耐受性。
研究配方組於40週PMA時之CRP血漿濃度比對照配方組顯著更高,但於50週PMA時無顯著差異,此說明類胡蘿蔔素對調節發炎症具有重要作用。由於40週PMA時(即,研究組嬰兒接受補充高濃度類胡蘿蔔素之SimilacSpecial Care研究配方時)之總類胡蘿蔔素攝取量比50週PMA時(即,研究組嬰兒接受補充較低濃度類胡蘿蔔素之NeoSure研究配方時)之總類胡蘿蔔素攝取量高至少兩倍,故類胡蘿蔔素對調節發炎症之作用與投與嬰兒之類胡蘿蔔素之量有關。
結果亦證明類胡蘿蔔素,β-胡蘿蔔素、葉黃素及蕃茄紅素之血漿濃度與CRP血漿濃度成反比。如拉曼光譜法所確定(數據未顯示),類胡蘿蔔素血漿濃度亦與皮膚類胡蘿蔔素濃度具高度相關性。
圖1係顯示如實例16中所述之對照配方組(不添加類胡蘿蔔素)嬰兒、研究配方組(添加類胡蘿蔔素)嬰兒及餵以人乳(HM)參照組嬰兒於研究天數(SD)1、出院及40週PMA時C-反應性蛋白質之血漿濃度中值之圖;
圖2係顯示如實例16中所揭示之研究配方組(添加類胡蘿蔔素)中可評估之嬰兒之C-反應性蛋白質之血漿濃度與葉黃素之血漿濃度之間之關係圖。葉黃素之血漿濃度與C-反應性蛋白質之血漿濃度成反比;
圖3係顯示如實例16所揭示研究配方組(添加類胡蘿蔔素)中可評估之嬰兒之C-反應性蛋白質之血漿濃度與蕃茄紅素之血漿濃度之間之關係圖。蕃茄紅素之血漿濃度與C-反應性蛋白質之血漿濃度成反比;及
圖4係顯示研究配方組(添加類胡蘿蔔素)中可評估之嬰兒之C-反應性蛋白質之血漿濃度與β-胡蘿蔔素之血漿濃度之間之關係圖。β-胡蘿蔔素之血漿濃度與C-反應性蛋白質之血漿濃度成反比。
(無元件符號說明)
Claims (21)
- 一種配方於製造用於調節早產兒發炎症之早產兒用配方之用途,其中該配方包含約75 μg/L至約500 μg/L葉黃素、約60 μg/L至約500 μg/L蕃茄紅素及約85 μg/L至約500 μg/L β-胡蘿蔔素。
- 如請求項1之用途,其中該早產兒發炎症係由降低早產兒之C-反應性蛋白質血漿濃度調節。
- 如請求項1之用途,其中將該早產兒用配方投與早產兒,直至該早產兒之C-反應性蛋白質血漿濃度下降。
- 如請求項1之用途,其中該發炎症係皮膚發炎。
- 如請求項1之用途,其中將該早產兒用配方投與早產兒,直至該早產兒達約40週月經後年齡(post-menstrual age)。
- 如請求項5之用途,其中將該早產兒用配方投與早產兒,直至該早產兒達約50週月經後年齡。
- 如請求項1之用途,其中該配方包含約200 μg/L至約250 μg/L葉黃素、約100 μg/L至約150 μg/L蕃茄紅素及約200 μg/L至約250 μg/L β-胡蘿蔔素。
- 如請求項7之用途,其中該配方包含約212 μg/L葉黃素、約143 μg/L蕃茄紅素及約220 μg/Lβ-胡蘿蔔素。
- 如請求項1之用途,其中該早產兒用配方提供早產兒約22 μg/kg/日至約150 μg/kg/日之葉黃素、約18 μg/kg/日至約150 μg/kg/日之蕃茄紅素及約26 μg/kg/日至約150 μg/kg/日之β-胡蘿蔔素。
- 如請求項1之用途,其中該早產兒用配方進一步包含約5 μg/L至約50 μg/L玉米黃質。
- 如請求項1之用途,其中該早產兒用配方進一步包含維生素、礦物質、碳水化合物、脂質及蛋白質中之至少一者。
- 如請求項11之用途,其中該早產兒用配方包含總卡路里百分比之約35%至約50%之碳水化合物、約30%至約60%之脂質(lipid)組分及約7.5%至約25%之蛋白質。
- 一種配方於製造用於調節早產兒之C-反應性蛋白質濃度之早產兒用配方之用途,其中該配方包含約75 μg/L至約500 μg/L葉黃素、約60 μg/L至約500 μg/L蕃茄紅素及約85 μg/L至約500 μg/L β-胡蘿蔔素。
- 如請求項13之用途,其中早產兒之C-反應性蛋白質濃度係由降低該早產兒之C-反應性蛋白質血漿濃度來調節。
- 如請求項13之用途,其中將該早產兒用配方投與早產兒,直至該早產兒之C-反應性蛋白質血漿濃度降低。
- 如請求項13之用途,其中該早產兒皮膚中之β-胡蘿蔔素、葉黃素及蕃茄紅素濃度升高。
- 如請求項16之用途,其中將該早產兒用配方投與早產兒,直至該早產兒達約40週月經後年齡。
- 如請求項13之用途,其中將該早產兒用配方投與早產兒,直至該早產兒達約50週月經後年齡。
- 如請求項13之用途,其中該配方包含約200 μg/L至約250 μg/L葉黃素、約100 μg/L至約150 μg/L蕃茄紅素及約200 μg/L至約250 μg/L β-胡蘿蔔素。
- 如請求項13之用途,其中該早產兒用配方提供該早產兒約22 μg/kg/日至約150 μg/kg/日之葉黃素、約18 μg/kg/日至約150 μg/kg/日之蕃茄紅素及約26 μg/kg/日至約150 μg/kg/日之β-胡蘿蔔素。
- 如請求項13之用途,其中該早產兒用配方進一步包含約5 μg/L至約50 μg/L玉米黃質。
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EP3727033A1 (en) * | 2017-12-22 | 2020-10-28 | Société des Produits Nestlé S.A. | Synthetic nutritional compositions tailored for infants of specific ages, and nutritional systems comprising them |
US20200329751A1 (en) * | 2017-12-22 | 2020-10-22 | Societe Des Produits Nestle S.A. | Gender specific synthetic nutritional compositions comprising lycopene and nutritional systems comprising them |
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US20110136734A1 (en) | 2011-06-09 |
WO2011068703A3 (en) | 2011-11-24 |
WO2011068703A2 (en) | 2011-06-09 |
TW201141466A (en) | 2011-12-01 |
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