TWI439234B - 高血糖抑制用營養組成物 - Google Patents
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- TWI439234B TWI439234B TW098103251A TW98103251A TWI439234B TW I439234 B TWI439234 B TW I439234B TW 098103251 A TW098103251 A TW 098103251A TW 98103251 A TW98103251 A TW 98103251A TW I439234 B TWI439234 B TW I439234B
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Description
本發明有關具有高血糖抑制作用之營養均衡優異之營養組成物。
必須胺基酸除維持人類生命以外,亦為營造每日生活愉快舒適所必須之營養要素,但由於對於各種疾病具有治療效果,因此已使用作為醫藥品、營養劑或補充品等之有效成分。
例如,提案有含有亮胺酸、異亮胺酸及纈胺酸之至少一種之耐糖能異常用藥劑及飲食品(專利文獻1及2)。該等公報中實際上於實施例中所用者為僅亮胺酸或亮胺酸、異亮胺酸及纈胺酸之混合物,並調查將該等對大鼠經口投與1.5克/公斤之量時血糖值之變化。因此,此耐糖能異常用藥劑尤其可有效地治療、改善及/或預防於難以使用以往糖尿病藥之具有肝臟障礙之耐糖能異常。
異麥芽酮糠(palatinose)及海藻糖為糠質之一種,提案有使用作為血糖值控制用營養組成物之必須成分(專利文獻3)。該發明中規定糠質之能量比率中異麥芽酮糖及/或海澡糖為60~100%,又另外,本發明人等對異麥芽酮糖之血糖值控制效果進行調查之後,確認若未使用佔糠質之68.5質量%以上之量的異麥芽酮糖,則無法充分發揮異麥芽酮糠之血糖值上升抑制效果(參見圖1)。
另一方面,以提案有含有選自亮胺酸、異亮胺酸及纈胺酸之一種或兩種以上之分支鏈胺基酸及異麥芽酮糠之肝障障礙者用之營養組成物(專利文獻4)。該發明之實施例中,於以糠質之75質量%之量使用異麥芽酮糠之情況,糠質更緩慢燃燒而具有較佳特性。
即使任一種上述各種營養組成物,雖可發揮血糖值上升抑制效果,但於長時間攝取後,尤其是糖質之消化吸收變差,而有營養均衡變大的問題。對於患有高血糖之患者一般會指導其營養限制,於三大營養素中尤其是作為能量基質之利用效率高的糖質由於修正高血糖而受到限制。於此等情況下,若大量使用由腸管吸收極為緩慢之上述異麥芽酮糠及海藻糖,則難以充分供給維持體內蛋白質合成或生體維持所必要之能量,若長時間持續該種狀態,則說起來有陷入低營養狀態之情況。因而關於其營養指導,推薦審慎應對,尤其對高齡者實施飲食療法時,為不使陷入營養不良,而推薦提供特別考慮適當能量之營養組成物(非專利文獻1)。然而,有關營養療法,熱切期望一種當然可使血糖值降低,且營養均衡優異而可效率良好地供給能量之營養組成物。
另一方面,伴隨著糖尿病之增加,糖尿病併發症之糖尿病性腎病之患者數量亦不斷增加。近幾年來,透析導入症病例中所佔之糖尿病性腎病之比例超過4成,亦報導於透析人口中腎失調原疾病亦最多(非專利文獻2),亦期望一種患有高血糖之腎臟病患者用之營養組成物。
[專利文獻1]特開2003-171271號公報
[專利文獻2]特開2006-28194號公報
[專利文獻3]WO20031022288號公報
[專利文獻4]特開2005-350371號公報
[非專利文獻1]基於科學根據之糖尿病診療指引,日本糖尿病學會編,第21-25頁,2004,南江堂
[非專利文獻2]日本透析醫學會統計調查委員會,透析學會誌,41(1),1,2008。
本發明目的在於提供一種即使長時間攝取時營養均衡性亦優異,且投藥後可抑制高血糖,可減輕胰島素投與量之營養組成物。
又,本發明目的係提供一種可減低糖質中異麥芽酮糖及/或海藻糖之含量,進而可減低異麥芽酮糖及/或海藻糖之絕對含量之營養組成物。
又,本發明之目的係提供一種患有高血糖之腎臟疾病患者用之營養組成物。
本發明係基於發現若併用游離異亮胺酸及/或游離亮胺酸、異麥芽酮糖及/或海藻糖以及中鏈脂肪酸三酸甘油酯,可獲得優異之高血糖抑制效果且獲得營養均衡優異之營養組成物,以及可減低糖質中異麥芽酮糖及/或海藻糖之含量進而可減低異麥芽酮糖及/或海藻糖之絕對含量而可解決上述課題據此完成者。
亦即,本發明提供一種高血糖抑制用營養組成物,其為含有氮源、脂質及糖質之營養組成物,其特徵為氮源中含有游離異亮胺酸及/或游離亮胺酸,脂質含有中鏈脂肪酸三酸甘油酯,糠質含有異麥芽酮糖及/或海藻糖。
本發明中使用之游離異亮胺酸及游離亮胺酸可使用L-體、D-體及DL-體之任一者,但較好使用L-體。本發明尤其較好使用游離異亮胺酸。該等游離異亮胺酸或游離亮胺酸每100kcal營養組成物較好含有0.1~2.0克,進而較好每100kcal營養組成物含有0.3~1.5克。
本發明中,作為氮源,可併用異亮胺酸及亮胺酸以外之游離胺基酸,例如穀胺酸及其鹽、纈胺酸、精胺酸及其鹽、殼胺醯胺、色胺酸、組胺酸及其鹽、甘胺酸、丙胺酸等,但較好全氮源中之異亮胺酸及/或亮胺酸之量為2質量%~100質量%,尤其較好為6質量%~80質量%,又更好為6質量%~40質量%。
本發明中,除上述氮源以外,亦可使用脫脂奶粉或全脂奶粉、酪蛋白或乳清及其分解物等之乳蛋白質源、膠原蛋白及其分解物、分離大豆蛋白質或小麥蛋白質及其分解物等之植物性蛋白質或其水解物(肽)。
又,氮源之比例,營養組成物之固體成分每100質量份,較好為12~27質量份。
本發明中,可使用中鏈脂肪酸三酸甘油酯作為脂質之全部或其一部分。其中,作為中鏈脂肪酸三酸甘油酯較好係構成脂肪酸三酸甘油酯之脂肪酸殘基之碳數為6~12,尤其較好是構成脂肪酸三酸甘油酯之脂肪酸殘基之碳數為8及/或10。本發明中使用之中鏈脂肪酸三酸甘油酯可為例如容易自市面上獲得者。
中鏈脂肪酸三酸甘油酯之能量效率優異,相較於由碳數16以上之脂肪酸(長鏈脂肪酸三酸甘油酯)所成之紅花油或大豆油等之一般食用油脂,其吸收速度較快速可謂與糖質相近者。再者於體內組織中,即使沒有如肉鹼之介質,於粒線體內亦可於體內儘速燃燒,不累積於生體內,生體能量之產生量非常高。因此,為不使血糖值升高之較佳脂肪,但此中鏈脂肪酸三酸甘油酯,除能量產生以外,並非維持生體機能所必要之必須胺基酸,僅其無法維持生體機能。因此,發明品之特定配合比具重要性。另一方面,由於上述一般食用油脂之長鏈脂肪酸三酸甘油酯亦為脂肪,因此卡路里高,雖不使血糖值上升,但於大量長期攝取時,有高血脂症發病、動脈硬化起因、胰島素抗性增大之情況,進而促進耐糠能異常。
本發明中,較好總脂質中之10~75質量%為中鏈脂肪酸三酸甘油酯,尤其較好為15質量%~60質量%。其他則使用食用油脂。作為食用油脂,除可舉例為棕櫚油、椰子油、棉籽油、向日葵油、花生油、紫蘇油、杏仁油、油菜籽油、大豆油、葵花油、橄欖油、米油、玉米油、芝麻油、可可奶油等植物性油脂、或牛油、豬油、魚油、奶油、奶油脂等之動物性油脂以外,亦可舉例有以人造奶油(shortening)等之加工油脂等,可依據用途選擇數種組合使用。該等油脂,尤其於含水分多的形態,較好使用脂肪酸單甘油酯或有機酸單甘油酯、聚甘油脂肪酸酯、蔗糖脂肪酸酯、卵磷脂等之乳化劑,予以乳化處理,成為適宜乳液之分散狀態。又較好以使尤其為必須脂肪酸之ω6系脂肪酸/ω3系脂肪酸比成為0.5~4.5之方式而決定選擇食用油脂或乳化劑及使用量。
脂質之比例較好為營養組成物之固體成分每100質量份為9~27質量份。
本發明中,作為糠質之一部分,係使用異麥芽酮糠及/或海藻糖,較好為異麥芽酮糠。糠質中異麥芽酮糖及/或海藻糖之含量較好為50質量%以下,尤其較好為5~40質量%。又,異麥芽酮糖及/或海藻糖之絕對含量,由營養均衡而言,較好每100kcal營養組成物為0.5至7.5克。作為其以外之糖質源,依據其記載並無特別限制,但其例可舉例為購得之消化吸收優異之作為能量源而加以利用之蛋白質或其分解物(糊精)、蔗糖、果糖等。
又,本發明中,糖質比例較好為營養組成物固體成分每100質量份為22~68質量份。
本發明中,異麥芽酮糖及/或海藻糖相對於異亮胺酸及/或亮胺酸之質量比較好為1/75~4/1,更好為1/50~2/1。
本發明中,作為卡路里源,除蛋白質或肽、胺基酸等之氮源、糠質、脂質以外,亦可使用於生體內作為能量加以利用脂各種食品材料。作為其例舉例有醇、一部分之食物纖維、寡糖、有機酸及其鹽等。除了配合該等作為卡路里源以外,亦可就有關其他營養素之補給、乳化或色調、流變學等之製劑安定性、風味提高、微生物對策、pH調整、於生體內之3次機能為目的,而可因應各種必要性加以選擇、使用。
如此,藉由含有特定量之游離異亮胺酸及/或游離亮胺酸、併用特定量之異麥芽酮糖及/或海藻糖,可觀察到相較於單獨攝取異麥芽酮糠及/或海藻糖更強之血糖值上升之抑制作用,進而藉由併用特定量之中鏈脂肪酸三酸甘油酯,可發揮更顯著之抑制效果。此營養組成物之特徵為,相較於迄今為止僅因降低血糖而備受矚目之先前技術,具有發揮不使血糖值上升而可效率良好地供給能量之作用。
本發明之營養組成物進而可含有食物纖維、維他命或礦物質等。作為食物纖維,舉例有難消化性糊精、果膠、半乳甘露聚糖等之水溶性食物纖維、源自大豆或小麥之糠麩或結晶纖維素等之非水溶性食物纖維。作為維他命,舉例有維他命A、維他命B1、維他命B2、維他命B6、維他命B12、維他命C、維他命R、維他命D3、菸鹼酸醯胺、葉酸、β-胡蘿蔔素、泛酸、維他命E、生物素等,作為礦物質,舉例有鈣、磷、銅、鋅、錳、鉻、鉬、硒、鐵、鈉、鉀、鎂、碘等。該等除了以有機酸鹽或無機酸鹽、化學合成品等為代表之食品添加劑以外,亦可調配有自各種食品萃取之萃取物或酵母等、源自各種食品材料者。再者,為使脂質等均一分散,亦可含有乳化劑等之界面活性劑。本發明之營養組成物進而可調配各種天然或合成甜味劑、著色劑、香料以及酪蛋白或α-硫辛酸等之所謂機能性營養素。
近幾年來,若因糖尿病等糠質代謝異常引起之高血糖狀態持續,則於生體內誘導因過剩活性氧引起之反應成為問題。氧化反應過剩之狀態為動脈硬化症等糖尿病併發症惡化之原因。相對於本發明,若於本發明中調配尤其是維他命A(β-胡蘿蔔素或視黃醇)、維他命E(生育酚)、維他命C或鋅或硒等之具有抗氧化能之維他命或微量元素則確實較佳。又,若亦併用其他之具有抗氧化活性之CoQ10或兒茶素、花色苷、異黃酮為代表之多酚等之機能性營養材料而進而更佳。
本發明藉調整鉀、磷含量,故即使對於伴隨有高血糖之腎臟病患者,亦可提供降低高血糖之危險性而可適當地營養管理之營養組成物。如此之伴隨有高血糖之腎臟病患者用之營養組成物中每100kcal之鉀含量較好為35~155毫克,進而最好為50~130毫克。又,較好為每100kcal之磷含量為20~100毫克,更好為35~80毫克。
今日,糖尿病持續增多,加上高齡化之高齡者中糖尿病患者數變得非常多。於高齡的糖尿病患者對臥床之營養管理或營養補給亦有使用管對胃中餵入營養組成物。一般高齡者的胃體積小,因此,於該等高齡者之情況,高濃度之高營養組成物為較佳。所以,可了解若投與加入有糠質之綜合營養之高濃度營養物,則高血糖之危險性將提高。
本發明之營養組成物之卡路里濃度若依據患者狀態使用最佳者,則較好為自0.5kcal/毫升開始至1.5kcal/毫升以上。尤其是對胃體積小的高齡者或伴隨有高血糖之腎臟病患者,對於可投與、攝取之營養組成物或水分量有其限制,較好為1.5kcal/毫升以上。上限並未特別限制,但較好為3.0kcal/毫升左右。本發明中,卡路里濃度高、亦為高營養價,而不引起高血糖。
本發明中,藉由組合胰島素刺激物質、類胰島素物質,則可進而增強有效性。於一例舉例有游離精胺酸。精胺酸係作用於胰臟β細胞為促進胰島素分泌之原因,截至目前為止,並不認為藉由併用此等物質及游離異亮胺酸及/或游離亮胺酸、異麥芽酮糖及/或海藻糖以及中鏈脂肪酸三酸甘油酯有較佳之相乘效果。所並用之該等物質中,若以上述精胺酸為例,較好併用0.01克~20克/100kcal,更好0.1克~10克/100kcal。關於調配游離精胺酸,於經口及經管投與時消化作用非必要之形態,例如係使用游離精胺酸、精胺酸鹽酸鹽、精胺酸硝酸鹽、精胺酸硫酸鹽、精胺酸有機酸鹽、精胺酸穀胺酸鹽等、游離精胺酸及其鹽之形態之原料。
作為本發明之營養組成物,可為粉末、顆粒狀、板狀、條狀、凝膠狀或液狀等之各種形態,但較好為液狀,尤其是經腸用之流體食物形態較佳。
本發明之營養組成物,對於經口攝取不完全之患者而言,可使用投與液狀物之管直接對腸或胃投與。尤其是直接對胃投與之情況下,有於胃食道營養組成物逆流而成為肺炎等重症症狀之原因之情況。此時,於本發明之營養組成物中添加增黏劑等可自由地調整組成物黏度。此情況較好為500mPa‧s以上、7,000mPa‧s(23℃)以下。再者,為減低高齡者誤吞嚥之危險,如何增加黏度均可。又依據情況將營養組成物調製成高黏度時,亦可藉由機械操作或稀釋等降低黏度後使用。
又,於本發明,亦可不添加增黏劑等,而藉由原材料之選擇、製造步驟之改變、製劑濃度之調整等,作成5~20,000mPa‧s(23℃)者而使用。
另一方面,投與營養物後之血糖值異常上昇,除單純之糖尿病等疾病以外,大多亦在進行外科手術時所引起。剛進行外科手術侵襲性大的手術後之時期,荷爾蒙環境變化變大,引起高血糖而成為手術後營養管理之問題點。而且,手術前之高血糖未經管理亦無法進行手術。本發明之營養組成物為在該等情況之營養管理下亦可降低血糖且亦具有營養恢復效果之適當組成物。
另外,耐糠能異常者,已知有引起血管障礙尤其是微血管之血流降低,而降低氧氣對末梢組織之供給。由此容易引起手術後之縫合不全,且對長期臥床之患者將發生褥瘡。因此,本發明可再管理血糖的同時適當地保有營養狀態,而可用於預防或治癒褥瘡、創傷。
於本發明,較好以每次服用至少可攝取0.3克游離異亮胺酸及/或游離亮胺酸之方式收容於容器中。也就是說,若攝取收容於容器中之食品全部,於人體胃中,可產生至少0.3克游離異亮胺酸及/或游離亮胺酸則較佳。
本發明之營養組成物作為經腸用之流動食物之形態時,較好收容於容量為50~1000毫升之容器中。又本發明營養組成物相較於於以往已知之高血糖抑制用營養組成物,由於抑制餐後高血糖之效果更高,因此亦可一次投與較多量。此情況下,可以用後即丟類型之包裝形態簡便且衛生地使用,且由於為大容量於輸送包材成本方面較有利,而可作成可在便宜環境下保管之製品而提供與消費者。此情況之每單位之填充量較好為300~600毫升,更好為300~400毫升。於高齡者或孩童之情況下,胃容積亦不大,此情況較好地是一次服用較好為80~400毫升,更好為100~300毫升。
作為收容本發明之營養組成物之容器,較好為易開封性之容器,又,較好為獨立性。作為該種容器舉例有特開2005-040630號公報、特開2003-327259號公報等中記載之容器。
另一方面,本發明之營養組成物中欲含有各種食品材料時,有於製造時或保存中其一部分引起氧化或分解之可能性。尤其油脂類容易引起劣化,其中由於大量含有魚油或紫蘇油、杏仁油等之高度不飽和脂肪酸而更容易氧化,導致不適臭味、味道劣化。又,教示有攝取含有過氧化物之油脂時,對生體而言成為氧化壓力,而有促進老化或致癌、成為生活習慣疾病之一原因。此種氧化或分解可藉由(i)製造方法或(ii)包裝形態之方法加以極力抑制。具體而言,可藉由下列而達成:(i)極力抑制製造時於調配液中捲入空氣或在遮光下實施;於調配後藉由脫氣裝置或充入惰性氣體而除去空氣;避免必要以上之加熱,於調配結束後殺菌處理之前儘可能保持於低溫狀態;填充係在惰性氣體環境氛圍下進行或填充後置換為惰性氣體,極力減少殘留氣體之方式加以密封;(ii)使用阻氣膜例如由鋁或氧化鋁、氧化矽等構成之蒸鍍薄膜或脫氧包裝材,進而封入AGELESS等之脫氧劑之包裝形態,進而使用以紫外線吸收油墨或特殊阻氣性油墨等進行表面印刷之包裝材,進而於外包裝材中進行捆包後氣體置換或脫氣處理等。藉此,亦可抑制因油脂氧化使維他命C或視黃醇、維他命E等之營養成分殘留率降低、風味惡化等,於本製品中成為更佳之形態。
[實施例]
以下以實施例詳細說明本發明,但本發明並不受該等實施例之限制。
實施例1
如表1中所示之調配比例計量原材料,且進行2,000kcal/2,000ml之裝入時之調配。於3升之不鏽鋼桶中計量入776克之調配水,且於熱水浴中加溫至70~80℃。邊攪拌邊投入糊精、不溶性食物纖維、含有礦物之酵母、生物素酵母、葡糠酸鋅、葡糖酸銅、檸檬酸亞鐵鈉並分散。接著,投入將食用油脂、中鏈脂肪酸三酸甘油酯、β-胡蘿蔔素懸浮液、維他命E油及乳化劑於70~80℃下混合溶解而成之液體。接著,於其中投入乳蛋白質、異麥芽酮糖、水溶性食物纖維並溶解。
另外,於不鏽鋼容器中注入180克之加溫水(30~40℃),且依序溶解檸檬酸、氫氧化鈣、檸檬酸三鈉、碳酸鉀、氯化鎂、甘油磷酸鈣、穀胺酸鈉,且將該溶液投入於3升不鏽鋼容器中之預先調製之溶液中,並經混合。接著,於其中投入異亮胺酸、異抗壞血酸鈉、綜合維他命,且分散溶解,接著加入香料。最後加入並溶解抗壞血酸鈉且混合。以調配水使總量成為2,000ml定量後,攪拌至成均勻溶液為止。以高壓均質機使該溶液乳化(均質壓力:70MPa)。將其填充於透明直立袋(standing pouch)(包裝材構成:蒸鍍PET/Ny/CPP)中每一個重量成為200ml(214g),在124℃下進行高壓蒸煮殺菌處理,於5天後測定該液體之黏度為6.4mPa‧s(24℃)。又,另外藉由無菌填充,填充於117ml(125g)之袋中。
其中,為透明直立袋之構成材料之Ny及CPP為尼龍及無延伸聚丙烯之簡稱(以下亦相同)。
該等任一種包裝形態中乳化亦為長期安定。又,該營養組成物為營養均衡優異者,且可長期持續攝取。其中,構成使用之中鏈脂肪酸三酸甘油酯之脂肪酸殘基之碳數為6~12。另外,ω6系脂肪酸/ω3系脂肪酸比係調整成為2.7。糖質中之異麥芽酮糖之含有量為16.4質量%(39.2/239.2),本發明品100kcal中之異麥芽酮糠量為1.96克。又,本發明品100kcal中游離異亮胺酸之量為0.5g,游離異亮胺酸/異麥芽酮糠之質量比為1/3.9(10/39.2)。
將增黏劑適度地添加於如此製造之本發明營養組成物中,使用旋轉式黏度計(BH-80,東機產業)測定黏度後,確認為亦可調整成350~20,000mPa‧s之安定高黏度組成物(23℃)。另外,使本發明品之溶液經噴霧乾躁,且藉由將其造粒,可穩定地製造出粉末及顆粒。進而於加熱之本發明品中適度的添加洋菜或購得之各種凍膠調製食品(例如,HERUSHU(註冊商標)凍膠構成物),經溶解並冷卻,亦可調製成凝膠狀之形態。
實施例2
如表2中所示之之原材料調配比例計量,且進行1,000g(2,000kcal)之裝入時之調配。於2升之不鏽鋼桶中計量入320克之調配水,且於熱水浴中加溫至70~80℃。接著,在TK ROBOMIX(PRIMIX公司)中,於3000rpm之高速攪伴條件化,依海藻糖、檸檬酸亞鐵鈉、葡糖酸鋅、葡糠酸銅、檸檬酸鉀、氯化鉀、磷酸鉀、葡糠酸鈉之順序混合溶解。接著投入於70~80℃下將食用油脂與中鏈脂肪酸三酸甘油酯、β-胡蘿蔔素懸浮液、維他命E油、乳化劑混合溶解而成之液體。隨後,依糊精、乳蛋白質、不溶性食物纖維、穀胺酸鈉、亮胺酸、含有各種礦物質之酵母、生物素酵母、香料之順序投入並混合,成為均勻之溶解分散溶液後,緩慢投入將水溶性食物纖維、硫酸鎂、氯化鎂、乳酸鈣溶解於120毫升調配水中而成之液體。隨後,投入綜合維他命、抗壞血酸鈉、異抗壞血酸鈉,並分散溶解。邊測定該等之重量邊加水至1,000克,且混合至成均勻狀態為止。使之以每100ml填充於附加噴管之直立帶(袋膜構成:PET/Al/Ny/CPP)中,且在125℃下進行高壓蒸煮殺菌。其比重為1.18,該溶液之卡路里濃度為2.0kcal/g(2.4kcal/ml)。將該試料儲存於25℃下,殺菌處理之隔天,以旋轉式黏度計(BH-80,東機產業),在3號轉子、12rpm之條件下測定後,約為4,000mPa‧s(25℃)。長期儲存下乳化亦長期穩定。於該液體中加水可調成500mPa‧s(25℃)之均質營養組成物,且亦可添加購得之增黏劑調整成7,000mPa‧s(25℃)之均質高黏度溶液。又,於加熱之本發明品中適度的添加洋菜或購得之各種凍膠調製食品(例如,HERUSHU(註冊商標)凍膠構成物),經溶解並冷卻,亦可調製成凝膠狀之形態。進而使本發明品之溶液經噴霧乾躁,藉由將其造粒,可穩定地製造出粉末及顆粒。構成其中使用之中鏈脂肪酸三酸甘油酯之脂肪酸殘基之碳數為8~10。另外,ω6系脂肪酸/ω3系脂肪酸比為1.5。糠質中之海藻糖之含量為9.5質量%(18.3/192.8),本發明品100kcal中之海藻糖量為0.92克。又,本發明品100kcal中游離亮胺酸之量為0.27g,游離亮胺酸/海藻糖之質量比為1/3.4(5.40/18.3)。
實施例3
如表3中所示之調配比例計量原材料,且以與實施例1相同之方法調製2,000kcal/2,000ml之營養組成物。將其填充於透明直立袋中使每個重量為200g。在124℃下進行高壓蒸煮殺菌處理。此時黏度為6.0mPa‧s(24℃)。乳化為長期安定。又,該營養組成物為營養均衡優異者,可長期持續攝取。構成其中使用之中鏈脂肪酸三酸甘油酯之脂肪酸殘基之碳數為6~12。另外,ω6系脂肪酸/ω3系脂肪酸比為4.0。糖質中之異麥芽酮糖之含有量為16.4質量%(39.2/239.2),本發明品100kcal中之異麥芽酮糖量為1.96克。又,本發明品100kcal中游離異亮胺酸之量為0.5g,游離異亮胺酸/異麥芽酮糖之質量比為1/3.9(10/39.2)。又,100kcal中之游離精胺酸為1.5克。
將增黏劑適度添加於如此製造之本發明營養組成物中,使用旋轉式黏度計(BH-80,東機產業)測定黏度後,為350~20,000mPa‧s,確認亦可調整成安定高黏度組成物(23℃)。另外,於加熱之本發明品中適度的添加洋菜或購得之各種膠凍調製食品(例如,例如,HERUSHU(註冊商標)凍膠構成物),經溶解並冷卻,亦可調製成凝膠狀之形態。另外使本發明品之溶液經噴霧乾躁,藉由將其造粒,可穩定地製造出粉末及顆粒。
實施例4
以表4中所示之調配比例計量原材料,且進行3000L(1kcal/1ml)之裝入時之實機試作。於1號桶中饋入1164kg(70~80℃)之溫水,邊攪拌邊加入糊精、不溶性食物纖維、含有礦物之酵母、檸檬酸亞鐵鈉。接著,加入使食用油脂、中鏈脂肪酸三酸甘油酯、β-胡蘿蔔素懸浮液、維他命E油及乳化劑於70~80℃下混合溶解而成之液體。接著,於其中投入乳蛋白質、異麥芽酮糖、水溶性食物纖維,並經溶解。
於另一桶中加入135kg之溫水(30~40℃),且依序溶解檸檬酸、氫氧化鈣、檸檬酸三鈉、碳酸鉀、氯化鎂、甘油磷酸鈣、殼胺酸鈉,且將該溶液加於預先調製之1號桶溶液中。經混合,且重複該操作兩次。接著,於其中加入異亮胺酸、異抗壞血酸鈉、綜合維他命,且分散溶解,再加入葉酸與香料。使該液體經除氣處理(約20cmHg)後,以高壓均質機在乳化壓力98MPa下處理,且藉由板冷卻機使液溫成為10℃以下。貯存於儲液桶中之後,加入抗壞血酸鈉並使之溶解,且以調配水使總量成為3000L定量,並攪拌至成均勻液體為止。將其填充於附加噴管之透明薄膜袋(袋膜構成:PET/蒸鍍PET/Ny/CPP)中使每個重量成為400ml,填充後以除氣棒使殘留氣體部分成為15毫升以下之狀態下以熱密封加以密封後,在124℃下進行高壓蒸煮殺菌處理。
於8天後測定該液體之黏度為6.3mPa‧s(24℃)。
另外,本發明品100kcal中之游離異亮胺酸之量為0.5克,游離異亮酸/異麥芽酮糠之質量比為1/3.9(15.0/58.8)。
試驗例1
對實施例4獲得之試作品,進行在室溫(25℃前後)儲存達6個月之長期安定性試驗。且對試驗開始時與在室溫下靜置6個月時之試作品進行物性值測定與各種評價。
‧粒度分佈(中值粒徑)
以雷射散射式粒度分佈測定裝置(LS 13 320(商品名),貝克曼‧柯達公司製造),使用PIDS(偏光差動散射)組件,在液體(懸浮液體部分):1.32,試料:實體部分1.45,虛擬部分0之條件解析射率。
‧pH
以pH計(HM-25R型(商品名),TOA DKK(股)公司製)測定。
‧黏度
以旋轉式黏度計(BH-80(商品名),東機產業公司製),使用10號轉子,在60rpm之條件下測定。
‧官能評價
針對風味、香味、舌觸感,以剛開始儲存之試作品做為標準試料進行比較。
與標準試料比較下,判斷毫無遜色之情況作為適當。
‧色差
測定用小瓶中採取5克試料,且使用分光式色彩計(SE-2000(商品名),日本電色工業(股)公司製)測定。
‧外觀
觀察隨著乳化狀態之變化產生之乳狀、或不溶性鹽之形成、色調顯著之變化等目視之狀態。
‧管中流動性
將管(JMS營養套組(商品名),JMS公司製)與5Fr之導管(SURFI FITTING TUBE(商品名),TERUMO公司製)連接於試料之噴管上,且自1m之高度使內容液自然滴下,測定每15分鐘滴下之量。連續滴下直至袋內無液體為止,求得每單位時間內之平均滴下流量,作為管中流動性。
‧耐酸性
採取100毫升之試料於燒杯內,使用攪拌器邊攪拌邊緩慢添加預先調製之2%鹽酸溶液。2分鐘後,觀察性狀,且測定pH。此時,測定至數十個以上之凝乳狀浮游物被確認為止(添加鹽酸溶液後產生之凝聚物未消失)之pH值。
比較例1
針對購得之流動食物(MEDIEFF(註冊商標)袋,味之素(股)製),進行與試驗例1相同之保存試驗,進行物性值測定及各種評價。
所得測定結果列於表5。即使於粒度分佈、pH、黏度、色差,經6個月之儲存均未看到有太大變化,且至少於6個月之期間顯示製品為具有充分安定性者。官能性評價中經時變化亦小,且可維持經口攝取上較佳之形態。又本發明品黏度低流動性良好,因此亦可使用各種營養管或導管,尤其是內徑小且長之形式亦可使用。另外由於耐酸性亦優異,因此對導管產生胃酸逆流時不易使流動食物產生凝固,而不會發生經報告為凝乳化原因之菌之增殖(非專利文獻3:外科與代謝、營養,日本外科代謝營養學會會刊,pp73,42(3),2008),即使與顯示酸性之藥劑同時或前後使用,宣稱不會引起管堵塞。由上述,本發明品於經管營養使用時,亦具有極佳之形態。
實施例5
如表6中所示之調配比例計量原材料,且進行4,500kcal/4,500ml之裝入時之調配。於5升之不鏽鋼桶中計量入2000克之調配水,且於熱水浴中加溫至70~80℃。邊攪拌邊投入糊精、不溶性食物纖維、乳蛋白質、異麥芽酮糖、水溶性食物纖維、含有礦物之酵母、生物素酵母、葡糖酸鋅、葡糖酸銅、檸檬酸亞鐵鈉、異亮胺酸、殼胺酸鈉並經分散。接著,投入將食用油脂、中鏈脂肪酸三酸甘油酯、β-胡蘿蔔素懸浮液、維他命E油及乳化劑於70~80℃下混合溶解而成之液體。
另外,於不鏽鋼容器中投入300克之加溫水(30~40℃),且依序溶解檸檬酸、氫氧化鈣、檸檬酸三鈉、碳酸鉀、氯化鎂,且將該溶液投入於5升不鏽鋼容器中之預先調製之溶液中,並經混合。接著,於其中投入磷酸三鈣、綜合維他命,並經分散溶解,且加入香料。最後加入並溶解異抗壞血酸鈉、抗壞血酸鈉且混合。以調配水使總量成為4,500ml定量之後,攪拌至成均勻溶液為止。以高壓均質機使該溶液乳化(均質壓力:70MPa)。將其填充於附加噴管之透明膜袋(袋膜構成:PET/蒸著PET/Ny/CPP)中使每個容量成為300ml,且在124℃下進行高壓蒸煮殺菌處理。本營養品之黏度為7.0mPa‧s(24℃),經時儲存安定性優異,尤其是高溫儲存時(40~60℃)亦極少發生乳狀,且亦認為沒有源自不溶性磷酸鈣之沉澱物之產生。風味及管中流動性亦良好。
另外,本發明品100kcal中之游離異亮胺酸之量為0.5克,游離異亮胺酸/異麥芽酮糖之質量比為1/3.9(22.5/88.2)。
發明品之營養組成物之效力評價實驗
實驗1(參考例:僅使用異麥芽酮糖時之效力)
使用為使耐糠能異常發病之糖尿病模型鼠之GK鼠(7週齡雄性,日本SLC(股))進行實驗。使GK鼠禁食18小時,且分別經口投與將糠質(12克/100kcal)之一部分置換成0克、4.4克、8.9克/100kcal之異麥芽酮糠之表7中所示之營養組成物A、B、C(實施例1之營養組成基礎,其中並未調配游離異亮胺酸)(12kcal/kgB.W.),且測定血糖值(測定機器:富士DRYCHEM 5500,富士膠片(股)製)。
其結果,營養組成物C相較於營養組成物A,在投與營養組成物15、30、60分鐘後血糖值之上升被有意義地抑制(15、30分鐘:p<0.01,60分鐘:p<0.05,參數性Dunnet型多重檢定,圖1)。但,營養組成物B與營養組成物A相較,並無法抑制血糖值之上升(圖1)。
由該結果,僅使用異麥芽酮糖,未與游離異亮胺酸併用之情況下,若未使用佔有糠質之約70質量%以上之量之異麥芽酮糖,則判定無法充分發揮異麥芽酮糖之血糖值上升抑制效果。
實驗2
對本發明品之血糖上升抑制效果,使用為呈現耐糠能異常之糖尿病模型鼠之GK鼠(鼠齡7週之雄性,日本SLC(股))進行實驗。對禁食18小時之鼠分別投與實施例1中調製之本發明營養組成物與未調配游離異亮胺酸及異麥芽酮糖之營養組成物A(12kcal/kgB.W.),且測定血糖值(測定機器:富士DRYCHEM 5500,富士膠片(股)製)。
圖2中顯示之結果,本發明品相較於營養組成物A,可有意地抑制投與營養組成物60、120分鐘後之血糖值上升(p<0.05,t檢定,圖2)。由該結果,判定藉由游離異亮胺酸與異麥芽酮糖之併用,可發揮極強的血糖上升抑制效果。異麥芽酮糖之血糖值上升抑制效果在未以糖質之約70質量%以上之比例調配異麥芽酮糖時無法充分發揮,但藉由併用每100kcal為0.5克之游離異亮胺酸時,可將異麥芽酮糠之量降低至糖質之16質量%。
實驗例3
透過GK老鼠(14週齡之雄鼠,日本SLC(股))之胃瘻,分別將實施例2中調製之本發明品與營養組成物D經管投入胃內(12kcal/kgB.W.),且測定血糖值(測定機器:富士DRYCHEM 5500,富士膠片(股)製)。營養組成物D係依據表8之調配,如實施例2般製造,且該溶液之卡路里濃度為2.4kcal/ml,又使以黏度為代表之物理性質與實施例2相同。關於油脂,係使ω6系脂肪酸/ω3系脂肪酸比成為1.5之方式調整食用油脂之使用比例。構成中鏈脂肪酸三酸甘油酯之脂肪酸殘基之碳數為6~12。該中鏈脂肪酸相對於全部脂肪之比例為18重量%。糠質中未含海藻糖,另外,亦不含游離亮胺酸。
該實驗結果,本發明品相較於營養組成物D,可有意義地抑制投與15、30、60分鐘後之血醣值上升(p<0.05,t檢定,圖3)。對照之營養組成物D係將卡路里濃度調整成2.4kcal/ml(比重1.18)之高卡路里,將其投與糖尿病模型老鼠時引發高血糖。然而,實施例2之組成即使以卡路里濃度成為2.4kcal/ml(比重1.18)投與之情況下,亦可抑制血糖上升(圖3)。
高齡糖尿病患者中,本身無法攝取營養,大多存在有藉由胃直接對胃投與營養組成物之患者。由於一般高齡者之胃容量較小,故使用之營養組成物較好為體積小且高卡路里濃度者,但在投與速度相同之情況下,提高卡路里濃度明顯的容易引起某程度之高血糖。然而,如結果所示,2.4kcal/ml之高卡路里濃度之本發明品確認並不會引起高血糖。
實驗4
使用為使耐糖能異常發病之糖尿病模型鼠之ZDF鼠(10週齡雄鼠,日本Charles River(股)),驗證本發明品之血紅蛋白Alc(HbAlc)之上升抑制效果。HbAlc為反映過去約一個月間血糖值之指標。另外,ZDF鼠為伴隨著病態惡化,自10週齡開始HbAlc緩慢上升,為顯示接近人類糖尿病惡化過程之狀態之模型。將老鼠以使HbAlc之平均值相等之方式分為2組後,分別自由的攝取每營養組成物100kcal含有0.5克游離異亮胺酸與2.0克異麥芽酮糖之營養組成物E,與未調配游離異亮胺酸及異麥芽酮糖之營養組成物F,比較4週後之HbAlc(營養組成物調配組成:表9,測定機器:DCA2000系統,SIEMENS MEDICAL SOLUTIONS‧DIAGNOSTICS(股)製)。營養組成物E及F之維他命、礦物質之調配係使用老鼠之標準飼料(AIN-93G維他命混合及AIN-93G礦物質混合,ORIENTAL酵母工業(股)製造)。
其結果,營養組成物E相較於營養組成物F,判定可有意義地抑制HbAlc之上升率,每營養組成物100kcal組合0.5克之游離異亮胺酸與2.0克異麥芽酮糖(游離異亮胺酸/異麥芽酮糠之質量比1/4,糖質中異麥芽酮糖之含量為12質量%),對於長期血糖之控制有用,且證明可在自由經口攝取之條件下抑制血糖上升(p<0.05,t檢定,圖4)。
實驗5
使用使耐糖能異常發病之鏈脲佐菌素(Streptozocin)(STZ)誘發性糖尿病老鼠,驗證本發明品之HbAlc之上升抑制效果。STZ誘發性糖尿病老鼠之HbAlc在投與STZ後上升,且顯示與人類糖尿病惡化之過程接近之狀態之模型。經腹腔內對SD老鼠(7週齡之雄鼠,日本Charles River(股))投與STZ 60mg/kgB.W.,製作糖尿病模型鼠。投與STZ 8天後,將老鼠以使HbAlc之平均值相等之方式分成2組後,分別自由攝取具有實施例1之組成之粉末狀營養組成物與未調配游離異亮胺酸及異麥芽酮糖之營養組成物A之粉末狀營養組成物,且比較6週後之HbAlc(測定機器:DCA2000系統,SIEMENS MEDICAL SOLUTIONS‧DIAGNOSTICS(股)製)。實施例1中所示之本發明營養組成物(未使用調配水)及營養組成物A之調配組成物係使用萬能混合攪拌機(DALTON(股)製),將原材料混合製作。
其結果,本發明之營養組成物相較於營養組成物A,判定可有意義地抑制HbAlc之上升。而且,證明本發明之營養組成物即使為粉末狀對於血糖之控制亦有用(p<0.01,t檢定,圖5)。
糖尿病患者及耐糖能異常之情況下營養攝取時急速血糖值上升之抑制係使用胰島素注射或經口降血糖藥。胰島素或經口降血糖藥為抑制血糖上升作用強者,但會伴隨著低血糖或胃腸受損、浮腫、貧血等副作用。另外,進行胰島素療法之過半數患者亦有認為「針刺疼痛」之報告(非專利文獻4:加來浩平,實務,22(3),240,2005),胰島素注射會造成大的精神壓力。本發明由於在長期攝取之情況下亦可抑制投藥期間中之高血糖,因此可減少胰島素及經口降血糖藥之投藥量,對於藥劑之副作用及針刺之壓力減輕具有貢獻。
實驗6
使呈現耐糖能異常之糖尿病模型鼠之GK鼠(日本SLC(股))落在低營養狀態,且驗證本發明組成物之營養效果。亦即,對11週齡之GK老鼠投與無蛋白質之老鼠飼料21天,製作耐糖能異常之低營養狀態之模型鼠。將該等老鼠依使體重及空腹時血糖值之平均相等之方式分成2組,藉由剖腹手術透過造設之胃,且使用朝胃內之泵,在第0~1天為20kcal/18小時/隻,第1~2天為45kcal/18小時/隻,第2~7天為65kcal/18小時/隻,第7天以後為71kcal/20小時/隻之量,對其一群在10天內經管投與實施例1之液狀本發明組成物,另一群在10天內經管投與據報告可良好地維持糖尿病患者之血糖控制之調配購得食物纖維‧寡糠,糖質‧脂質調整液營養食品(「TABION」(註冊商標),α:以下,Tα)(非專利文獻5:齋藤Mari,靜脈經腸營養,23(增刊號),311,2008)。表10中顯示Tα之主要營養組成。
實施該試驗之結果,投與中(投與結束1小時前)之血糖值為本發明品組比Tα更低之值(圖6)。另外,本發明品組之體內氮氣良好維持(圖7),於飼育期間變長之情況營養均衡優異之本發明品組體重成為高值(圖8),有效地驗證本發明品之營養均衡。耐糖能異常者,由於因代謝異常引起之血管障礙或血流降低,容易引起手術後之縫合不全或因長期臥床而引起褥瘡。於創傷或褥瘡之治癒而言營養均衡之營養素不可或缺,因均衡差之營養攝取引起之營養不良狀態提高該等發病之危險性,導致治癒延長。本發明之營養組成可抑制攝取後之高血糖且可適當保持營養狀態,非常有用於創傷、褥瘡之預防或促進治癒。
實驗7
使呈現耐糠能異常之糖尿病模型鼠之GK鼠(日本SLC(股))落在低營養狀態,且驗證本發明組成物之營養效果。亦即,對5週齡之GK老鼠投與無蛋白質之老鼠飼料21天,製作耐糠能異常之低營養狀態之模型鼠。將該等老鼠分成2組,使用投與噴嘴,以第1~2天為20kcal/100g B.W.、第3天以後為25kcal/100g B.W.之量對一組投與實施例1之液狀本發明組成物且對另一組投與Tα,共攝取8天。該Tα於糠質中並未調配異麥芽酮糠、海藻糖或游離異亮胺酸或游離亮胺酸亦未調配中鏈脂肪酸三酸甘油酯。又,ω6系脂肪酸/ω3系脂肪酸比為3.6。實施該試驗之結果,於飼育期間變長之情況營養均衡優異之本發明品組體重成為高值(圖9)。而且,確認本發明品不僅是經管投與時,即使經口攝取時亦為營養均衡優異之組成。
實驗8
使用為使耐糠能異常發病之糖尿病模型鼠之GK鼠(25週齡雄性,日本SLC(股))進行實驗。對禁食18小時之鼠,以8kcal/kg投與實施例1調配之本發明之營養組成物,以6kcal/kg投與未調配游離異亮胺酸及異麥芽酮糖之營養組成物A,並測定血糖(測定機器:富士DRYCHEM 5500,富士膠片(股)製)。
投與本發明品後之血糖值,於比營養組成物A投與量多亦無關地顯示同樣的血糖推移(p=0.05,t檢定,圖10)。此結果顯示具有血糖值抑制效果之本發明品,比不考慮血糖值上升抑制之營養組成物,能攝取更多的能量或營養素。本結果,於不考慮血糖值上升抑制之營養組成物之攝取時,相對於具有血糖值上升疑慮而每次僅能攝取225毫升,本發明品為顯示可攝取約1.3倍之300毫升者。為血糖值不會上升之營養均衡優異之營養組成物的本發明品之攝取量增加,有助於維持、改善糖尿病患者之營養狀態。其中,對於營養狀態惡化之糖尿病患者,本發明品可投與營養均衡良好之高卡路里而為非常有用之組成。
圖1為用以確認異麥芽酮糖之效果,而調製營養組成物A~C,將該等經口投與後之血糖值推移之圖。
圖2為顯示以實施例1調配之本發明品與營養組成物A經口投與後之血糖值推移之圖。
圖3為顯示以實施例2調配之本發明品與營養組成物D經口投與後之血糖值推移之圖。
圖4為顯示營養組成物E及營養組成物F長期經口投與後之血紅蛋白Alc之變化率之圖。
圖5為顯示實施例1之粉末狀本發明品及營養組成物A長期經口投與後之血紅蛋白Alc之變化率之圖。
圖6為顯示於實施例1調製之本發明品與購得T α之經管投與中之血糖值之圖。
圖7為顯示於實施例1調製之本發明品與購得T α之經管投與後之氮產出之圖。
圖8為顯示於實施例1調製之本發明品與購得T α之經管投與後之體重推移之圖。
圖9為顯示於實施例1調製之本發明品與購得T α之經口攝取後之體重增加率之圖。
圖10為顯示於實施例1調製之本發明品(8kcal/kg B.W.)及營養組成物A(6kcal/kg B.W.)經口投與後之血糖值推移之圖。
Claims (19)
- 一種高血糖抑制用營養組成物,其為含有氮源、脂質及糖質之營養組成物,其特徵為氮源中含有游離異亮胺酸及/或游離亮胺酸,脂質含有中鏈脂肪酸三酸甘油酯,糖質含有異麥芽酮糖(palatinose)及/或海藻糖。
- 如申請專利範圍第1項之營養組成物,其相當於每100kcal之營養組成物含有0.1~2.0克之游離異亮胺酸及/或游離亮胺酸。
- 如申請專利範圍第1或2項之營養組成物,其中構成中鏈脂肪酸三酸甘油酯之脂肪酸殘基之碳數為6~12。
- 如申請專利範圍第3項之營養組成物,其中構成中鏈脂肪酸三酸甘油酯之脂肪酸殘基之碳數為8及/或10。
- 如申請專利範圍第1或2項之營養組成物,其中中鏈脂肪酸三酸甘油酯之含量為總脂肪中之10~75重量%。
- 如申請專利範圍第1或2項之營養組成物,其中糖質中之異麥芽酮糖及/或海藻糖之含量為50質量%以下。
- 如申請專利範圍第1或2項之營養組成物,其中異麥芽酮糖及/或海藻糖相對於游離異亮胺酸及/或游離亮胺酸之質量比為1/75~4/1。
- 如申請專利範圍第1或2項之營養組成物,其係與胰島素分泌刺激物質併用。
- 如申請專利範圍第1或2項之營養組成物,其中該營養組成物之形態為粉末、顆粒狀、板狀、桿狀、凝膠狀或液狀。
- 如申請專利範圍第1或2項之營養組成物,其中該營養組成物為經腸用之流體食用形態。
- 如申請專利範圍第1或2項之營養組成物,其中該營養組成物係收容於容器中。
- 如申請專利範圍第11項之營養組成物,其中將300~600毫升之營養組成物收容於容器中。
- 如申請專利範圍第1或2項之營養組成物,其係透過使用於抑制源自光、空氣、加熱而導致內容物之氧化或分解之經步驟控制的製造步驟而製造營養組成物,且係收容於儲存時可抑制源自氧或氧及光而導致劣化之包裝材料所構成之容器中。
- 如申請專利範圍第1或2項之營養組成物,其中該營養組成物之卡路里濃度為1.5kcal/ml以上。
- 如申請專利範圍第1或2項之營養組成物,其中該營養組成物之黏度為500mPa.s以上。
- 如申請專利範圍第1或2項之營養組成物,其係用於促進褥瘡、創傷之預防及治療。
- 如申請專利範圍第1或2項之營養組成物,其係用於手術前後之營養管理。
- 如申請專利範圍第1或2項之營養組成物,其係用於減輕或防止高血糖所引起之氧化壓力。
- 如申請專利範圍第1或2項之營養組成物,其每100kcal含有35~155毫克鉀、20~100毫克磷而供伴隨有高血糖之腎臟病患者使用。
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US5470839A (en) * | 1993-04-22 | 1995-11-28 | Clintec Nutrition Company | Enteral diet and method for providing nutrition to a diabetic |
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JPH11158075A (ja) * | 1997-11-25 | 1999-06-15 | Hayashibara Biochem Lab Inc | 膵機能調節剤 |
MY135783A (en) * | 2001-09-07 | 2008-06-30 | Meiji Dairies Corp | Nutritional composition for controlling blood sugar level |
JPWO2004022049A1 (ja) * | 2002-09-05 | 2005-12-22 | 日清オイリオグループ株式会社 | 痩身剤およびその飲食物 |
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WO2009096579A1 (ja) | 2009-08-06 |
TW200942181A (en) | 2009-10-16 |
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