JP2012504971A - 高カロリー経腸製剤 - Google Patents
高カロリー経腸製剤 Download PDFInfo
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- JP2012504971A JP2012504971A JP2011531245A JP2011531245A JP2012504971A JP 2012504971 A JP2012504971 A JP 2012504971A JP 2011531245 A JP2011531245 A JP 2011531245A JP 2011531245 A JP2011531245 A JP 2011531245A JP 2012504971 A JP2012504971 A JP 2012504971A
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- soy
- soy protein
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- eating
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Abstract
Description
本出願は、2008年10月10日に出願された米国仮特許出願第61/104,554号の優先権を主張するものであり、その全体を本明細書の一部を構成するものとしてここに援用する。
本発明は、代謝的および/または生理的負荷が加わっている対象の栄養所要量を満たすことを対象とする組成物を提供する。この組成物は、高カロリー濃度を有すると同時に、低粘度および許容可能な保存安定性を有することが可能である。本発明の製剤は、好ましくは、加水分解された大豆タンパク質を利用している。
大豆タンパク質製品は、タンパク質含有量が高く、オリゴ糖/炭水化物含有量が低い。さらに、大豆タンパク質製品は、「完全な」タンパク質を提供する。大豆は人体で合成することができず食事で補わなければならない人間栄養学的に必須のアミノ酸をすべて含んでいる。大豆タンパク質は、高タンパク質/低炭水化物含有量であることに加えて、コレステロールを含有していない。数十年間に亘る栄養学的研究においては、血清コレステロールが危険値にある人が大豆タンパク質を含む食事を摂取することによってその濃度が実際に低減することが示されている。さらに、血中コレステロール濃度が高くなるほど大豆タンパクがその濃度を低下させる効果が高くなる。
炭水化物は、組成物のカロリー量の約35〜約65%を提供してもよい。炭水化物供給源は、組成物のカロリー量の約35、40、45、50、55、60、65%であるかまたはそれを超えてもよい。本発明には多くの炭水化物を使用してもよい。例示的な炭水化物供給源としては、これらに限定されるものではないが、マルトデキストリン、コーンスターチ、スクロース、粉飴、および大豆繊維が挙げられる。
本発明の組成物は、そのまま使用できる経腸製剤であってもよい。この組成物は、代謝的および/または生理的負荷が加わっている患者の栄養所要量を総合的に提供するものであってもよいし、あるいは栄養補助剤として作用するものであってもよい。この組成物は、対象に経管栄養で摂取させてもよいし、あるいはこの製剤を患者に飲用させることによって摂取させてもよい。例えば、この組成物は、缶または皮下注射針および吊り下げバッグ(hang bag)で提供してもよい。この組成物は、使用前に水等による再調製(reconstitution)または混合を行うことを必要とせずそのまま使用できるように提供してもよい。別法として、この組成物は、使用前に水等で再調製するかまたは混合するように提供してもよい。
本発明は、本発明の組成物を利用する方法を提供する。本発明の一態様においては、対象に栄養を供給する方法は、酵素的に加水分解された大豆タンパク質材料を含む製剤を対象に投与することを含み、この大豆タンパク質材料の加水分解度は約0.1%〜約16%、好ましくは約0.1〜約5%である。投与経路は、経口投与、経鼻投与、経胃栄養管(gastric feeding tube)、経十二指腸栄養管(duodenal feeding tube)、他の消化器系に基づく栄養法等を介した経腸的なものである。
「加水分解度」(DH)という用語は、加水分解された具体的なペプチド結合の割合(すなわち、完全な状態のタンパク質中に存在するペプチド結合の数のうち切断された数)を指す。
経腸栄養製剤は、経腸栄養を受けている対象の栄養必要量を満たすために開発された高カロリー濃度製品であってもよい。経腸栄養製剤は、経口的に、重力によるかまたはポンプを用いて投与され、したがって、最終製品の保存期間に亘る粘度および安定性は、栄養群の標的の量および時間に適合させるという観点で重要である。乳および大豆タンパク質成分を経腸栄養製剤に使用する際に付随する典型的な問題としては、含有量が増加するにつれて初期粘度が高くなるかまたは時間の経過に伴い粘度が上昇することが挙げられる。酵素的に処理された乳および大豆タンパク質成分は粘度の問題を軽減するのを助けるであろう。
より高カロリーな経腸栄養製剤(1.5kcal/ml)に含まれる乳タンパク質全体のうちの相当量を、低粘度および良好な溶解性を示すことを特徴とする新規な酵素処理された大豆タンパク質を用いて置き換えることによって、低粘度および許容可能な安定性の両方を有する生成物が得られた。高カロリー栄養製剤試料の詳細を表2に示す。
標準的な手順の後に試料のpH測定を実施した。対照試料のpHは約6.8〜6.9の範囲にあり、大豆含有試料は約6.6〜6.7の範囲にあった。どの生成物のpHも時間が経過しても大きく変化しなかった。保存期間の評価中は安定なままであった(表3)。
製剤試料の粘度を粘度計を用いて測定した。具体的には、試料を振盪して均質な分散液が得られたらすぐに180mlのビーカーに注いだ。視認できる泡は測定前に全て取り除いた。一定時間が経過した後、スピンドル#2を取り付けたブルックフィールド粘度計(型式DV−II+)を用いて、粘度(センチポイズ単位(cP))を25℃〜30℃(77°F〜86°F)、30RPMで1分間測定した。結果を表4に示す。
HunterLab Colorimeter(型式DP−9000)を用いて製剤試料の色を測定した。この装置を標準的な手順に従い較正した。試料を振盪して均質な分散液を得た。試料の温度を約25℃〜30℃(77°F〜86°F)とした。各試料を同量ずつ試料用カップに注ぎ(Agtron 内径57mm、ガラスカタログNo.11595、Magnuson Engineering,Inc.)、捕捉された気泡は全て除去した。試料を満たしたカップを装置の測定ポートに載置し、蓋をした。試料の測定値を読み取り、結果をL、a、およびb単位で記録した。
製剤の安定性に関し、0、2、および8週間の貯蔵寿命で評価した(表7)。静置しておいた各試料の生成物の缶を開封して、クリーム化、乳清、沈降、および粒子について目視で検査した。一旦開封した後、飲料の最上層の外観をクリーム化および粒子について主観的に評価した。次いで、試料を注いで乳清および沈殿について検査した。内部で開発した尺度に基づき試料の安定性を示す評点を付けたものを表6に示す。
実施例1と同様の手順を用いて、含有される総タンパク質の100%が大豆から誘導されたものである高カロリー栄養製剤を調製した。配合は、金属イオン封止剤を最適化するように変更することによって安定性を最大限にするとともに、使用したタンパク質供給源に関わらず全試料のミネラルプロファイルを類似したものにするようにした。時間の経過に伴う安定性を評価するため、商業的滅菌された生成物を無菌の透明プラスチックボトルに移し替えた(表8)。
経腸栄養製剤は、経腸栄養を受けている対象の栄養所要量を満たすために開発され高カロリー濃度製品であってもよい。経腸栄養製剤は、経口的に、重力によるかまたはポンプを用いて投与され、したがって、最終製品の保存期間に亘る粘度および安定性は、栄養群の標的の量および期間を満たすという観点で重要である。乳および大豆タンパク質成分を経腸栄養製剤に使用する際に付随する典型的な問題としては、含有量が増加するについれて初期粘度が高くなるかまたは時間の経過に伴い粘度が上昇することが挙げられる。酵素的に処理された乳および大豆タンパク質成分は粘度の問題の軽減を助けるであろう。
Claims (18)
- 約1.4kcal/ml〜約2.1kcal/mlのカロリー濃度、約30〜110センチポイズの範囲の低粘度、および最終滅菌後に安定な特性を保持する能力を有する飲食用組成物であって、
a.加水分解度が約0.1%〜約16%である酵素的に加水分解された大豆タンパク質材料と、
b.炭水化物供給源と、
c.脂質供給源と、
d.必須微量栄養素と
を含む、飲食用組成物。 - 前記大豆タンパク質材料の加水分解度が約0.1%〜約5%である、請求項1に記載の飲食用組成物。
- 前記組成物が液体である、請求項1に記載の飲食用組成物。
- 前記必須微量栄養素が、U.S.RDIの100%のビタミン類およびミネラル類またはUS RDIの100%を超えるビタミン類およびミネラル類からなる群から選択される、請求項1に記載の飲食用組成物。
- 前記組成物が、EU FSMPの特定の最終用途の所要量の最小〜最大の範囲の栄養素をさらに含む、請求項1に記載の飲食用組成物。
- 前記大豆タンパク質材料が、大豆タンパク質、分離大豆タンパク、濃縮大豆タンパク、大豆タンパク質抽出物、大豆粉、粉末または乾燥豆乳、粗砕大豆、磨砕大豆、大豆ペースト、およびこれらの組合せからなる群から選択される、請求項1に記載の飲食用組成物。
- 前記粘度が、約30〜約200センチポイズである、請求項1に記載の飲食用組成物。
- 前記粘度が、約50〜約150センチポイズである、請求項1に記載の飲食用組成物。
- 前記炭水化物供給源が、マルトデキストリン、粉飴、糖、大豆繊維、短鎖フラクトオリゴサッカライズ、またはこれらの組合せからなる群から選択される、請求項1に記載の飲食用組成物。
- 前記脂質供給源が、カノーラ油、中鎖脂肪酸トリグリセリド、大豆油、またはこれらの組合せからなる群から選択される、請求項1に記載の飲食用組成物。
- 水、塩供給源、カルシウム供給源、プロバイオティクス、およびこれらの組合せからなる群から選択される成分をさらに含む、請求項1に記載の飲食用組成物。
- 栄養を必要とする対象にそれを提供する方法であって、前記対象に、加水分解度が約0.1%〜約16%である酵素的に加水分解された大豆タンパク質材料を含む製剤を投与することを含む、方法。
- 対象に栄養を提供するための前記方法が、経腸投与である、請求項12に記載の方法。
- 前記製剤が、U.S.RDIの100%のビタミン類およびミネラル類またはUS RDIの100%を超えるビタミン類およびミネラル類からなる群から選択される必須微量栄養素を含む、請求項12に記載の方法。
- 前記製剤が、EU FSMPの特定の最終用途の所要量の最小〜最大の範囲の栄養素を含む、請求項12に記載の方法。
- 前記大豆タンパク質材料が、大豆タンパク質、分離大豆タンパク、濃縮大豆タンパク、大豆タンパク質抽出物、大豆粉、粉末または乾燥豆乳、粗砕大豆、磨砕大豆、大豆ペースト、およびこれらの組合せからなる群から選択される、請求項12に記載の方法。
- 前記粘度が、約30〜約200センチポイズである、請求項12に記載の方法。
- 前記飲食用組成物が、商業的無菌性を達成するための熱処理後に安定な特性を保持している、請求項12に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10455408P | 2008-10-10 | 2008-10-10 | |
US61/104,554 | 2008-10-10 | ||
PCT/US2009/060384 WO2010042932A1 (en) | 2008-10-10 | 2009-10-12 | High caloric enteral formulations |
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JP2012504971A5 JP2012504971A5 (ja) | 2012-11-29 |
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US (1) | US9259024B2 (ja) |
EP (1) | EP2330920A1 (ja) |
JP (1) | JP5619014B2 (ja) |
KR (1) | KR20110084909A (ja) |
CN (1) | CN102176835B (ja) |
BR (1) | BRPI0914023A2 (ja) |
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JP2021528040A (ja) * | 2018-06-18 | 2021-10-21 | オーガライフ ニュートリション サイエンス カンパニー リミテッド | 経口/経腸栄養組成物及びその製造方法 |
Families Citing this family (11)
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US20110172142A1 (en) * | 2008-09-12 | 2011-07-14 | Solae, Llc | Functional Food Paste |
WO2011150364A2 (en) * | 2010-05-28 | 2011-12-01 | Compatible Technology International | Therapeutic food formulation |
WO2014011029A1 (en) * | 2012-07-09 | 2014-01-16 | N.V. Nutricia | Method for producing a protein and lipid comprising composition with reduced digestive coagulation |
MX2015007938A (es) | 2012-12-18 | 2015-10-09 | Abbott Lab | Composicion nutricional oral con baja viscosidad y alta densidad calorica y metodos relacionados. |
CA3006448A1 (en) | 2015-12-18 | 2017-06-22 | Nestec S.A. | Heat sterilized high protein compositions with hydrolyzed protein from a continuous process with at least one endopeptidase |
JP2018538004A (ja) * | 2015-12-28 | 2018-12-27 | アボット・ラボラトリーズAbbott Laboratories | 低粘性で高カロリー密度の栄養組成物 |
CN107006843A (zh) * | 2017-03-06 | 2017-08-04 | 东北农业大学 | 一种营养全面、易消化吸收的肠内营养粉及其制备方法 |
EP3524051A1 (en) * | 2018-02-12 | 2019-08-14 | DuPont Nutrition Biosciences ApS | Matricial microencapsulation compositions |
CN108783459B (zh) * | 2018-07-03 | 2022-03-29 | 麦孚营养科技(北京)有限公司 | 豌豆蛋白低渣营养配方制品、其制备方法及其用途 |
CN111920059B (zh) * | 2020-06-28 | 2022-06-14 | 华南理工大学 | 一种大豆ace抑制肽及其制备方法和应用 |
CN113439839A (zh) * | 2021-06-18 | 2021-09-28 | 华南理工大学 | 一种全植物基高能量即饮营养品及其制备方法 |
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- 2009-10-12 CA CA2735153A patent/CA2735153A1/en not_active Abandoned
- 2009-10-12 WO PCT/US2009/060384 patent/WO2010042932A1/en active Application Filing
- 2009-10-12 JP JP2011531245A patent/JP5619014B2/ja active Active
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JPH06340544A (ja) * | 1993-05-28 | 1994-12-13 | Abbott Lab | 放射線療法及び/又は化学療法を受けている患者のための栄養製剤 |
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JP2021528040A (ja) * | 2018-06-18 | 2021-10-21 | オーガライフ ニュートリション サイエンス カンパニー リミテッド | 経口/経腸栄養組成物及びその製造方法 |
JP7467345B2 (ja) | 2018-06-18 | 2024-04-15 | オーガライフ ニュートリショナル サイエンス カンパニー リミテッド | 経口/経腸栄養組成物及びその製造方法 |
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EP2330920A1 (en) | 2011-06-15 |
US9259024B2 (en) | 2016-02-16 |
CA2735153A1 (en) | 2010-04-15 |
JP5619014B2 (ja) | 2014-11-05 |
CN102176835A (zh) | 2011-09-07 |
KR20110084909A (ko) | 2011-07-26 |
US20110183900A1 (en) | 2011-07-28 |
WO2010042932A1 (en) | 2010-04-15 |
BRPI0914023A2 (pt) | 2016-07-26 |
CN102176835B (zh) | 2015-07-22 |
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