JP2013510865A - 腸内微生物叢バランス及び健康を促進するための栄養組成物 - Google Patents
腸内微生物叢バランス及び健康を促進するための栄養組成物 Download PDFInfo
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Abstract
【選択図】 図13A
Description
[0001]本出願は2009年11月12日に出願された米国特許出願第61/260,495号の優先権を主張し、その全体の内容は明示的に参照により本明細書に組み込まれている。
[0002]本開示は、腸内微生物叢バランス及び健康を促進するための食物繊維を含む栄養組成物、並びに腸内微生物叢バランス及び健康を改善する方法に関し、この方法は有効量のそのような組成物を投与することを含む。
[0009]2〜60(平均で10〜12)の範囲の重合度(「DP」);及び
[0010]約6〜10%の遊離糖類(フルクトース、グルコース、及びスクロース)。
[0018]短鎖=<10DP。
[0022]本開示はここで、新規栄養組成物を提供し、これは同組成物を必要とする個体に投与した場合に栄養を供給するのに十分な相対量でFOS、多糖、及びイヌリンの組み合わせを含む。この組成物は個体が必要とする栄養の補給を行い、経口投与されてもよい。経管栄養を必要とする患者における腸内投与も可能である。
[0094]経腸栄養法は、栄養必要量を経口によって満たすことができない個体に栄養分を送達する好ましい方法である。標準処方物は、特定の臨床上の懸念がない個体において最も一般的に使用される。これらの処方物は、健康な集団に対する推奨に合致し一般に耐容性が良好である、主要栄養素含量及び微量栄養素含量を有する。以前には、チューブの詰まりの問題、並びに腸管安静が有益であるという考えにより、繊維を含まない経腸処方物が好まれた。以来、繊維による詰まりの問題はほとんど排除されているので、この集団に望ましい多くの有益な生理的効果を与えるために、繊維をそのような処方物に加えることができることが今では認識されている。
[0095]繊維は食物内容物の水分含量及び嵩を増加させ、腸管を通した便通の進行を正常化させる。このように、食物繊維は便通の規則性の改善、軟らかい形態の便の生成の促進、及び排便の容易さ及び制御の改善に寄与する。さらに、可溶性の粘性繊維は、コレステロールを低下させる効果を含めた多くの代謝上の利益を有する。これらの繊維の存在は腸の内容物の粘度を上昇させ、回腸における胆汁酸の吸収を妨げることができ、糞便の胆汁酸の損失が増加することを引き起こす。その結果として、肝臓によってLDLコレステロールが血液から除去され、この損失を補うために胆汁酸へと転化される。同様に、粘性繊維はまた、栄養分摂取に対するグルコース及びインスリンの応答を弱めることもある。これらの繊維は胃の粘度を上昇させることができ、その結果胃内容物排出を遅らせる。さらに、上昇した糜汁の粘度によって、腸のグルコース吸収の速度が遅くなり、インスリンの必要量が低下する。胃の内容物の粘度を上昇させることによって、これらの繊維は胃食道逆流、逆流、及び嘔吐の発現の回数も減少させ、これは経腸栄養の耐容性を改善する。
[0096]およそ100兆個の微生物が通常の成人の腸管に存在している。有益な細菌と病原性細菌とのバランスは正常な腸の生理機能を維持するのに極めて重要であり、これはこのバランスが免疫機能並びに栄養分の消化及び吸収に対して直接的な影響を与えるからである。定義によれば、プレバイオティクス物質は「宿主の福祉及び健康に利益を与える胃腸の微生物叢の組成及び/又は活性の両方に特定の変化をもたらす、選択的に発酵した成分」である。これは典型的にはビフィズス菌及び/又はラクトバシラス菌の増加を指す。プレバイオティクス物質(又は略してプレバイオティクス)の利点としては、以下が挙げられる:
[0098](2)有益な細菌集団の増殖促進及び病原性細菌亜集団の減少;
[0099](3)大腸における上皮細胞の主要なエネルギー源である、SCFA(例えば酪酸塩)の産生;SCFAはNa+及び水の吸収の調節も助ける;及び
[00100](4)腸の免疫細胞と病原性細菌との相互作用による、宿主の免疫の改善。
[00101]下痢及び便秘は、繊維を含まない経腸処方物に対して患者の間で共通の不満である。繊維は排便の頻度及び通過時間を正常化することが分かっており、したがって繊維は規則性を促進するために処方物に加えることができる。繊維を添加した経腸処方物についての51の研究を含む最近のメタ分析では、繊維の投与によって下痢の発生が減少し便通の頻度が低い場合には高くなることが分かり、これは腸機能に対する繊維の緩和効果を支援する。同様に、専門家の委員会は、下痢、便秘、及び摂食耐性における利点に基づき、禁忌がなければすべての患者の食事に繊維を加えることを推奨した。ESPEN、Guidelines 2006を参照のこと。繊維のさらなる利点としては、腸バリア機能の改善、結腸上皮の増殖、液体及び電解質の吸収の向上、胃食道逆流、逆流、及び嘔吐の緩和、経腸栄養の耐容性向上、並びに血糖管理及び血清の脂質パラメーターにおける利点が挙げられる。一方で、繊維の添加は場合により膨満感及び鼓腸などの胃腸の副作用を引き起こすことが報告されている。したがって、胃腸の副作用が最小限である繊維の種類及び量を加えることが重要である。
[00106]本開示は、70:30の比であるFOS及びイヌリン(PREBIO1(商標))並びに1:1の比であるFOS及びAGを含む、新しい改良された組成物を提供する。これは異なる速度で発酵する様々な短鎖(FOS)、中鎖(イヌリン)、及び長鎖(AG)繊維を提供し、その結果結腸の全長にわたって利益をもたらす。
[00116](a)European Society for Parenteral and Enteral Nutrition(「ESPEN」):手術後の患者を含めた正常な腸機能を有する患者には、添加した繊維が有益である場合がある;10〜15g繊維/Lが適切な最小量である;
[00117](b)Institute of Medicine(「IOM」)及びAmerican Dietetic Association(「ADA」):14g繊維/1000kcal;並びに
[00118](c)American Diabetes Association(「ADA」):15〜25g繊維/1000kcal。
[00120]末期の腎臓病の患者は、消化障害、特に便秘に悩まされる。末期の腎臓病患者のおよそ50%が便秘に悩まされる。Murtagh FEM、Addington−Hall J、Higginson IJ.、The Prevalence of Symptoms in End−Stage Renal Disease:A Systematic Review.Advances in Chronic Kidney Disease 2007年;14(1):82〜89頁を参照のこと。PHGGはグアーガムから抽出される独特な水溶性食物繊維である。グアーガムの元来の高い粘度は加水分解後にほとんど除去され、このことによってグ流動食及び栄養的処方物に加えるのに理想的なものとなる。腸の規則性、特に便秘におけるPHGGの有益性を支持するテータがある。PHGGの有益な効果の多くは、他の可溶性繊維よりもはるかに多くの酪酸塩を産生する、結腸でのその完全な発酵に起因する可能性が高い。Velazquez M、Davies C、Marett R、Slavin J、Feirtag J.、Effect of oligosaccharides and fibre substitutes on short chain fatty acid production by human faeca microflora、Anaerobe 2000年; 6(2):87〜92頁を参照のこと。近位結腸で急速に発酵する他の可溶性繊維と同様に、PHGGは便通の重量を大幅には増加させない。しかしいくつかの研究は、PHGGが、特に経腸栄養を受ける患者及び他のハイリスクの集団における、腸機能の正常化、下痢及び便秘の両方の防止又は軽減に有益であることを示している。Slavin JL、Greenberg NA.2003年、Partially Hydrolyzed Guar Gum:Clinical Nutrition Uses、Nutrition;19:549〜552頁を参照のこと。
[00144]本開示の一実施形態は、35〜44重量%の量のフラクトオリゴ糖(FOS);38重量%〜50重量%の量の多糖;及び12〜24重量%の量のイヌリンを含む、個体へ投与するための栄養組成物である。FOS及び多糖は、62:38〜38:62の重量比で存在してもよく、FOS及びイヌリンは82:18〜58:42の重量比で存在してもよい。さらなる実施形態において、FOSは40〜42重量%である。さらなる実施形態において、FOSは約41重量%である。さらなる実施形態において、多糖はAGである。さらなる実施形態において、多糖は40〜50%である。さらなる実施形態において、多糖は約41重量%である。さらなる実施形態において、AGは40〜42重量%である。さらなる実施形態において、AGは約41重量%である。さらなる実施形態において、イヌリンは15〜21重量%である。さらなる実施形態において、イヌリンは18重量%である。さらなる実施形態において、栄養組成物は40〜42重量%の量の(FOS);40重量%〜42重量%の量のAG;及び15〜21重量%の量のイヌリンを含む。さらなる実施形態において、栄養組成物は41重量%の量の(FOS);41重量%の量のAG;及び18重量%の量のイヌリンを含む。さらなる実施形態において、FOS及び多糖は55:45〜45:55の重量比で存在する。さらなる実施形態において、FOS及び多糖は約1:1の重量比で存在する。さらなる実施形態において、FOS及びイヌリンは76:24〜64:36の重量比で存在する。さらなる実施形態において、FOS及びイヌリンは7:3の重量比で存在する。さらなる実施形態において、多糖はアラビノガラクタンであり、FOSは3〜5.5g/Lの量で存在し、アラビノガラクタンは3〜5.5g/Lの量で存在し、イヌリンは1〜2.5g/Lの量で存在する。さらなる実施形態において、栄養組成物は最大で10g/Lの(PHGG)をさらに含む。さらなる実施形態において、アラビノガラクタンはAGであり、FOS及びAGはそれぞれ4.12g/Lの量で存在し、イヌリンは1.76g/Lの量で存在し、PHGGは7g/Lの量で存在する。さらなる実施形態において、アラビノガラクタンはAGであり、FOS及びAGはそれぞれ4.12g/Lの量で存在し、イヌリンは1.76g/Lの量で存在し、PHGGは5g/Lの量で存在する。さらなる実施形態において、アラビノガラクタンはAGであり、FOS及びAGはそれぞれ4.12g/Lの量で存在し、イヌリンは1.76g/Lの量で存在し、PHGGは2.6g/L量で存在する。さらなる実施形態において、(FOS)は35重量%の量;多糖は50重量%の量;イヌリンは15重量%の量である。さらなる実施形態において、(FOS)は35重量%の量;AGは50重量%の量;イヌリンは15重量%の量である。
[00183]このプロジェクトは、革新的な栄養の考え方によって栄養補助食品を刷新して、成長及び保護(子供の防御力を強化する)に有益な分野における製品価値の提案を強めることを狙いとした。
[00186]臨床試験は、機械的人工呼吸及び経腸栄養を必要とする94人の子供が小児集中治療室(「PICU」)に入院しているNakhon Ratchasima(タイ)で行った。研究はほぼ3年間行われた。耐容性/安全性の分析は、カロリー摂取量の総パーセンテージ及び目標カロリー摂取量に到達する時間の両方を考慮に入れており、一方有益性の分析ではNCC2461(ST11)株及びNCC3001(BB536)株の存在を含めて糞便の微生物叢組成を評価する。
[00187]これは二重盲検対照無作為臨床試験とした。試験製品及び対照製品の2つの製品を調べた。
[00188]プロバイオティクスNCC2461/NCC3001+プレバイオティクス(PREBIOl(商標)+AG)+DHAを含む経腸処方物
[00189]プロバイオティクス及びプレバイオティクス又はDHAを添加していない、等カロリー、等タンパクの処方物
[00190]94人の患者は無作為化され、及び治療することを意図され、すべての人が少なくとも1日はいくらかの試験製品を摂取した。88人の患者は3日を超える経腸栄養を受けた(PPデータセット)。
カロリー摂取量の総パーセンテージ
[00191]24時間で投与された総量を利用日数にわたって合計し日数×重量×70kcal/kg/日で割ることによって、入院中のカロリー摂取量の総パーセンテージを計算した。これを各対象者について行った。カロリー摂取量の総パーセンテージをウィルコクソン順位和検定(Wilcoxon rank−sum test)によって分析し、信頼区間をホッジス−レーマン(Hodges−Lehman)に従って計算した。要約統計量及び治療間の差を表2に示す。
[00194]毎日の目標カロリー摂取量に達する時間は、毎日のエネルギー摂取(「DEI」)が100%を超えた時間である。子供がある日にちにちょうど100%に達することは予期されなかったので、この時間はそれぞれの子供について100%DEIが測定される前の日と100%DEIが測定された後の日との間で線形補間によって計算した。7日間の経管栄養の間に1日のカロリー目標値に達しなかった子供を検閲した。図1に示すカプランマイヤー(Kaplan Meier)プロットで示されるように、試験グループ及び対照グループにおいてそれぞれ36%及び29%の子供が7日間にわたってカロリー目標値に達しなかった。カロリー目標値に達する時間の中央値は試験グループ及び対照グループにおいてそれぞれ5.10日及び5.03日であった。時間の差は1時間で、95%信頼区間は29時間から61時間にわたっている。これは2つの試験製品の間の非劣性をさらに示す。
[00199]糞便の微生物叢組成を、非常に重篤な環境(高い感染のリスクを有する抗生物質治療中の患者)における腸バランスを反映する重要なパラメーターとして選択した。以下の細菌群を測定した:ビフィドバクテリウム属(Bifidobacterum)、ラクトバシラス属、バクテロイデス/ポルフィロモナス(Porphyromonas)/プレボテラ(Prevotella)グループ、腸内細菌科(Enterobactericeae)、ウェルシュ菌種、及びエンテロコッカス属。平均値(log10)を表4に示す。
[00204]結果は、PREBIO1(商標)及びAGの両方を含む栄養補助食品による経腸栄養が、PREBIO1(商標)のみを含む既に市販されているNutren Jr.よりも耐容性が良好であることを示している。さらに、Nutren Jr.と比較して、New Nutren Jr.は既知の病原体をそのメンバーの中に含む細菌群(腸内細菌、クロストリジウム(Clostridia))の減少の促進だけでなく、有益な効果があると言われる微生物群(ビフィズス菌)の増加の促進にもより効果的であり、したがって病気の子供の微生物叢組成のバランスを良い方向に整える。
[00206]腸の微生物叢の広範囲の乱れを併せ持つ入院中の幼児の栄養不良は、急性の下痢の症状の発現並びに院内感染の腸内病原体源を長期間保有することの両方を促進する状態である。
[00207]本発明の研究は、プロバイオティクス及びプレバイオティクスを含有する経腸処方物の耐容性、PICUにおけるその安全使用、及びその腸内細菌の生態系を支える能力を実証することを目的とした。
[00208]機械的人工呼吸及び経腸栄養を必要とする1歳〜3歳の94人のPICU患者は、プロバイオティクス、プレバイオティクス、及びDHAを含有する試験処方物、又は対照の等カロリー及び等タンパクの処方物を受けるように無作為化された。患者は7日間PICUにとどまり、14日目にさらに検査を受けた。第1の目的は、カロリー目標値への前進によって測定される耐容性を評価することであり、第2の目的は、安全な使用及び腸内微生物叢の改善を測定することである。
[00209]総カロリー摂取量は2つの処方物の間で差がなかった。カロリー目標値に達する時間の中央値は、試験グループで5.1、対照グループで5.03であった(p=0.67)。安全性に関しては、現在の臨床診療の期間内で、両方のグループの患者は危篤状態から回復しPICUから退院した。経腸処方物の安全な使用の裏付けとなる根拠として、腹部飽満、嘔吐、及び便通頻度/下痢の違いは2つの試験製品の間で見られなかった。さらに、いずれのグループでも副作用は見られなかった。
[00211]プロバイオティクス及びプレバイオティクスを添加した処方物の使用はPICUにおける経腸栄養の耐容性を変化させない。さらに、そのような処方物は安全であり、重篤な病気の子供の微生物叢組成の好ましいバランスを促進する。
[00216]インビトロの装備を用いて選択された製品の考えられるプレバイオティクス特性を詳細に研究するために、複雑な腸の微生物生態系を長期間にわたって代表的条件下で培養することを可能にする連続モデルを使用した。さらに、従来のインビトロ及びインビボによる研究は、プレバイオティクス特性の評価を化合物の連続投与の2〜3週間後にのみ行うことができることを示しているので、このモデルはプレバイオティクスの繰り返しの摂取をシミュレートすることを可能にするべきである。したがって、ヒト胃腸管の動的SHIMEシミュレータを使用して、プレバイオティクスによる治療の有効性を評価した。
[00222]実験の全体にわたって多くの微生物パラメーターをモニタリングしており、例えば短鎖脂肪酸、アンモニウム、乳酸塩分析、ガス分析、腸のpH、及び試料採取が挙げられる。
[00223]SCFAは、主に腸内細菌による糖分解発酵の典型的な最終生成物であり、SCFAのプロファイルは主に酢酸塩、プロピオン酸塩、及び酪酸塩と、イソ酪酸、吉草酸、イソ吉草酸、及びカプロン酸などの少量の他の酸とから成る。酢酸塩は腸から吸収することができ、宿主によってエネルギー基質として利用されるが、一方酪酸塩は腸上皮の主なエネルギー基質として働き、炎症及び結腸癌に対する保護効果が立証されている。プロピオン酸塩は最終的には酪酸塩と比較して同様の局所的活性を腸内で有するが、これは肝臓にも運ばれ、ここではコレステロールを低下させる良い効果及び血糖管理に対する効果を有することが分かった。そのため、酪酸塩及びプロピオン酸塩は酢酸塩と比較して宿主にとってより健康に有益であると考えられ、腸内の微生物発酵のプロファイルを酪酸塩及び/又はプロピオン酸塩産生の増加へ向けて調節することが有益であると考えられる。
[00230]アンモニウムの産生は主にタンパク質分解の結果であり、直接的及び非直接的な健康に有害な影響と関連するので、したがってアンモニウム産生の減少は有益であると考えられることになろう。この実験の間、試料をすべての結腸区画から週に3回採取した。実験の全過程にわたる異なる結腸領域におけるアンモニウム濃度の分析を図6A及び6Bに示す。明確に示されるように、両製品は治療期間中のアンモニウム産生の減少を引き起こした。
[00233]ヒトの腸管は、乳酸塩を産生する細菌及び乳酸塩を利用する細菌の両方を保有する。乳酸塩は乳酸菌によって産生され、抗菌剤としても作用する環境のpHを低下させる。これは他の微生物によって酢酸塩、酪酸塩、及びプロピオン酸塩へと急速に転化され得る。この短期間の研究のために、試料をすべての結腸区画から週に3回採取した。実験の全過程にわたる異なる結腸領域における乳酸塩濃度の分析を図7A及び7Bに示す。
[00235]最適な環境条件を維持することを確実にするために、SHIMEシステムにおけるpHをpHコントローラによって以下の範囲で制御する:(i)5.6〜5.8(上行結腸、「AC」)、(ii)6.2〜6.4(横行結腸、「TC」)、及び(iii)6.6〜6.8(下行結腸、「DC」)。しかし、異なる反応器中で微生物群が安定化すると(植菌後2週間より始まる)、微生物群はそれ自身が自動調節し、酸−塩基の消費は通常は低い。しかし、治療の間に細菌が試験製品に適応し、例えば増加した量のSCFAを産生する場合、反応器中の環境は酸性化することがあり、これは塩基をそれぞれの反応器にさらに投与することによるさらなるpH制御をもたらす。これに関連して、実験中の酸性化の度合いを、プレバイオティクスブレンドの細菌代謝の強さの指標として使用できる。
[00238]全ガス産生量の評価は、この研究の2つのブレンドについての潜在的な耐容性の問題に関連する重要な側面である。しかし、オンラインの全ガス産生量測定は、連続的なガスの流入及び流出のために腸の連続的モデルでは難しい。そのため、全ガス産生量の評価及びCO2濃度変化の測定はバッチ式装備で行った。ガス分析に関して、シミュレートした結腸の条件下でさらなるバッチ試験を行って全ガス産生量及び気相組成の推量を測定した。
[00244]試料を週に1回TWINSHIMEの各結腸区画から採取して、定量ポリメラーゼ連鎖反応(「qPCR」)によって管腔の微生物群組成における治療の効果を評価し、プレートカウントによって粘膜関連微生物群(mucosa−associated microbial community)を分析した。
[00245]qPCRを用いて全細菌、ビフィズス菌、ラクトバシラス菌、ファーミキューテス門、及びバクテロイデス門をモニタリングした。qPCRは、特定の細菌の配列(165 rRNA 遺伝子)を増幅させることに基づく分子技術であり、微生物の生態系におけるこれらの特定の配列の数を様々な時点で定量化することと組み合わせされている。この方法は細菌の培養能(の欠如)に依存しないので、この方法によって生じるデータは、プレバイオティクス的治療による微生物群における定量的な効果について、より信頼性のある概観を提供する。
[00254]特異的な細菌−宿主の相互作用、及び所与の治療によるこのプロセスの修正は、今やプレバイオティクス繊維の健康効果を決定する最も重要な要因の1つと考えられている。ヒトの腸管は、例えば病原体の定着を防ぐことによって及び重要な栄養分を産生することによってヒトの健康維持に関与している、大きく複雑な微生物群を保有する。微生物は腸管全体に無作為に分布しておらず、腸壁に接着する微生物は、それらが粘膜の免疫反応を指示し、潜在的に有害な生着菌(病原体)を犠牲にして生態学的適所(niche)を占めるので、重要な役割を果たす。この相互作用は、影響の受けやすさ及び複雑さによる問題のためにインビボで研究するのが非常に難しいので、プレバイオティクスが健康を促進する細菌の腸壁への接着を強化する能力を有するかどうかを評価するために、ProDigest及びLabMET(UGent)は近年革新的なインビトロのツールボックスを開発した。このアッセイは、SHIME反応器から異なる時点で採取される試料を用いて特定の結腸領域から得られる腸の微生物群の付着を調査すること、及び付着した細菌群内の様々な細菌グループ(全嫌気性菌、クロストリジウム、ビフィズス菌、ラクトバシラス菌、及び糞便の腸菌群)を定量化することを含む。次いでデータを処理していわゆる接着関連プレバイオティクス指数(Adhesion Related Prebiotic Index(AR−PI))を次式:
に従って計算する(Van den Abbeeleら、「In vitro model to study the modulation of the mucin−adhered bacterial community」、Appl.Microbiol.Biotechnol.(2009年)を参照のこと)。
[00262]両ブレンドは十分に発酵し、毒性のアンモニウム産生の減少をもたらした。すべての結腸の部分の酸性化及びより緩やかなガス産生によって示されるように、FOS及びイヌリンをAGによって部分的に置き換える(ブレンド1+)ことが、近位結腸での強い発酵から結腸全体での緩やかな発酵へと腸の発酵を変化させる。FOS及びイヌリンをAGによって置き換えることは、SCFA産生量の差を引き起こした。ブレンド1の酪酸特異的効果がより高かった。ブレンド1+はより高いプロピオン酸塩濃度を引き起こした。両ブレンドはビフィズス菌特異性を示した。FOS及びイヌリンをアカシアゴムによって部分的に置き換えることは、そのプレバイオティクス活性に好ましくない影響を与えない。さらに、ブレンド1+はブレンド1と比較して上行結腸でのより大きなラクトバシラス菌の増加を引き起こした。AGはFOS及びイヌリンと比較してより選択的及びより特異的に発酵する。
[00264]微生物群活性に関してこの短期間の研究のいくつかの結論を下記にまとめる。
[00270]微生物群組成に関するこの短期間の研究のいくつかの結論を下記にまとめる。全細菌、ビフィズス菌、ラクトバシラス菌、ファーミキューテス門、及びバクテロイデス門をモニタリングするために、qPCRを培養に依存しない方法として使用した。
[00274]ブレンド1は主に近位結腸で発酵し、上行結腸でAR−PIにおける即時の効果を与える。第2週及び第3週の間、細菌は製品に適応し始める。横行結腸においても細菌は影響を受けたが、この効果を観察するのに全治療期間を要する。下行結腸では効果が見られなかった。したがって、ブレンド1+は恐らくよりバランスがとれておりより発酵が難しい処方物である。そのため、これはすべての結腸にわたって影響を与える。
Claims (43)
- 約35〜約44重量%の量のフラクトオリゴ糖(FOS)と、部分加水分解グアーガム(PHGG)ではない約38重量%〜約50重量%の量で存在する多糖と、12〜24重量%の量のイヌリンとを含み、FOS及び多糖が62:38〜38:62の重量比で存在し、FOS及びイヌリンが82:18〜58:42の重量比で存在する、個体に投与するための栄養組成物。
- 多糖がアカシアゴム(「AG」)である、請求項1に記載の栄養組成物。
- FOS及び多糖が約55:45〜約45:55の重量比で存在する、請求項1に記載の栄養組成物。
- FOS及びイヌリンが約76:24〜約64:36の重量比で存在する、請求項1に記載の栄養組成物。
- 多糖がアラビノガラクタンであり、FOSが1.5〜5.5g/Lの量で存在し、アラビノガラクタンが約2.5〜5.5g/Lの量で存在し、イヌリンが約0.5〜2.5g/Lの量で存在する、請求項1に記載の栄養組成物。
- 10g/LまでのPHGGをさらに含む、請求項5に記載の栄養組成物。
- 個体の消化機能を高めるのに有効な量で少なくとも1つの不溶性繊維をさらに含み、少なくとも1つの不溶性繊維がダイズ繊維、エンドウ外皮繊維、又はそれらの組み合わせである、請求項1に記載の栄養組成物。
- 可溶性繊維及び不溶性繊維が約1.5:1〜約1:1.5の比で存在し、FOS及びAGが約2.5〜3.5g/Lの総量で存在し、イヌリンが約1.25〜1.75g/Lの量で存在し、ダイズ繊維及びエンドウ外皮繊維がそれぞれ約3.25〜4.25g/Lの量で存在する、請求項7に記載の栄養組成物。
- 可溶性繊維及び不溶性繊維がそれぞれ約1.25:1及び約1:1.25の比で存在する、請求項8に記載の栄養組成物。
- 抗酸化剤、魚油、DHA、EPA、ビタミン、ミネラル、植物栄養素、タンパク質、脂肪、プロバイオティクス、及びそれらの組み合わせのうちの少なくとも1つをさらに含む、請求項1に記載の栄養組成物。
- 腸内微生物叢バランス及び健康を促進する方法であって、請求項1〜10のいずれか一項に記載の栄養組成物の有効量を、そのような治療を必要とする個体に投与するステップを含む、方法。
- 前記腸内微生物叢バランス及び健康の促進が、胃腸系障害を引き起こす様々な医療に対する患者の耐性の改善であり、そのような治療が、放射線治療、化学療法、胃腸手術、麻酔、抗生物質、鎮痛薬の投与、又は下痢の治療を含む、請求項11に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、より良好な追いつき成長など、全身的な利益を子供にもたらすことである、請求項11に記載の方法。
- 前記全身的な利益をもたらすことが、子供における追いつき成長である、請求項13に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、そのような処方物のより高い耐容性によって患者が許容可能な栄養レベル及び摂食目標を実現し、そのようにして摂食要件のコンプライアンスを向上させ、合併症を減少させることを可能にしながら、そのような患者の入院期間を短縮することである、請求項11に記載の方法。
- 前記減少させる合併症が、下痢、便秘、胃食道逆流、逆流、嘔吐、及びそれらの組み合わせから成る群から選択される、請求項15に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、個体の免疫系を刺激することである、請求項11に記載の方法。
- 前記刺激された免疫系がGALT機能の改善を含む、請求項17に記載の方法。
- 前記刺激された免疫系がsIgAレベルの増加を含み、Th1/Th2の均衡をもたらす、請求項17に記載の方法。
- 前記刺激された免疫系が、個体が病気に抵抗する能力を高める、請求項17に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、臓器移植耐性を改善することであり、前記栄養組成物が、独特の上方制御をもたらす特定のコロニー形成を与える、請求項11に記載の方法。
- 前記上方制御が、除脂肪体重の減少を引き起こす炎症性サイトカインの減少を引き起こす、請求項21に記載の方法。
- 前記上方制御が、GLP−1及びGLP−2を介して、インスリン放出の減少を引き起こす、請求項21に記載の方法。
- 前記上方制御がTH1/TH2の不均衡の減少をもたらす、請求項21に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、骨の運動性並び骨成長を改善する又は骨分解を防ぐ機能を強化するように、それを必要とする患者の骨成長を改善する又は骨分解を防ぐことである、請求項11に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、個体の腸管及び結腸におけるビタミン、ミネラル、栄養分、及びそれらの組み合わせの吸収を増加させることである、請求項11に記載の方法。
- 筋肉の成長を助ける、請求項26に記載の方法。
- 筋肉量の欠乏を防ぐ、請求項26に記載の方法。
- 病後又は負傷後の筋肉量の回復を改善する、請求項26に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、胃腸管によって生成されるか又は胃腸管によって調整されるホルモンを調節することであり、ホルモンを調節することが、炎症ホルモンを個体において減少させること、個体の幸福感を高めること、セロトニンを増加させること、セロトニンが個体の睡眠パターンの改善をもたらすこと、セロトニンが個体の睡眠の質の向上をもたらすこと、セロトニンが食欲の正常化をもたらすこと、セロトニンが鬱病の減少をもたらすこと、認知力を改善すること、TH1/TH2の不均衡の減少、TH1/TH2の不均衡の減少がぜんそく発生の減少をもたらすこと、TH1/TH2の不均衡の減少が中耳炎の減少をもたらすことのうちの少なくとも1つである、請求項11に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、患者の結腸における酪酸塩の産生を増加させることであり、請求項1〜10のいずれか一項に記載の栄養組成物の有効量を患者に投与して、AGを含有しない処方物と比較して酪酸塩の産生を増加させて、結腸における細胞増殖を生じさせて、結腸のpHを低下させて、病原性細菌の成長を阻害するステップを含む、請求項11に記載の方法。
- 前記酪酸塩の産生が、患者の腸バリアの保護を助ける抗炎症性の利点、より良好なミネラルの吸収、胃腸の通過時間の正常化、下痢の減少のうち少なくとも1つをもたらす、請求項31に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、健康管理にかかる費用の減少をもたらし、前記健康管理にかかる費用の減少が、病院に滞在する長さの減少、介護施設に滞在する長さの減少、合併症の減少、下痢の発生の減少、便秘の発生の減少、憩室炎の発生の減少、又はそれらの組み合わせのうち少なくとも1つによるものである、請求項11に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、有益な細菌が優勢である微生物叢バランスの経時的に持続した移行である、請求項11に記載の方法。
- 前記有益な細菌がビフィズス菌、ラクトバシラス菌、又はビフィズス菌及びラクトバシラス菌である、請求項34に記載の方法。
- 病原体を減少させる、請求項34に記載の方法。
- 病原体がクロストリジウム(Clostridia)である、請求項36に記載の方法。
- 遠位結腸においてクロストリジウムを減少させる、請求項36に記載の方法。
- 前記腸内微生物叢バランス及び健康の促進が、結腸全体にわたった、発酵の持続、短鎖脂肪酸の産生、下行結腸における炭水化物発酵の持続及びタンパク質発酵の減少をもたらす上行結腸から下行結腸への糖分解発酵の移行、又はそれらの組み合わせである、請求項11に記載の方法。
- より良好な栄養分の再吸収、水分の再吸収、又は電解質の再吸収、又はそれらの組み合わせがある、請求項39に記載の方法。
- 腸の規則性の改善、便秘の改善、下痢の改善、過敏性腸症候群の改善、クローン病の改善、潰瘍性大腸炎の改善、又はそれらの組み合わせがある、請求項39に記載の方法。
- 重要な短鎖脂肪酸、酪酸塩、プロピオン酸塩、又はそれらの組み合わせの産生がある、請求項39に記載の方法。
- 結腸の全長にわたって、pHの低下、結腸細胞に好ましい基質、結腸細胞へのより良好な栄養分の提供がある、請求項39に記載の方法。
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EP (1) | EP2498626B1 (ja) |
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CN (2) | CN104206946A (ja) |
AU (1) | AU2010319490B2 (ja) |
BR (1) | BR112012011294B1 (ja) |
CA (1) | CA2777941C (ja) |
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JP2016189757A (ja) * | 2015-03-31 | 2016-11-10 | 株式会社東洋新薬 | 除脂肪体重の増加剤 |
JP2020189799A (ja) * | 2019-05-21 | 2020-11-26 | フジ日本精糖株式会社 | イヌリンを含む筋肉量減少抑制又は骨密度減少抑制剤 |
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WO2022091736A1 (ja) * | 2020-10-29 | 2022-05-05 | 旭松食品株式会社 | 腸内細菌叢改善用組成物及び腸内腐敗物質産生抑制用組成物 |
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AU2010319490B2 (en) | 2015-03-19 |
BR112012011294B1 (pt) | 2018-03-20 |
CA2777941A1 (en) | 2011-05-19 |
JP2016166176A (ja) | 2016-09-15 |
HK1172516A1 (en) | 2013-04-26 |
EP2498626B1 (en) | 2015-06-17 |
MX2012004778A (es) | 2012-06-01 |
WO2011060123A1 (en) | 2011-05-19 |
US20160100617A1 (en) | 2016-04-14 |
MX336032B (es) | 2016-01-07 |
RU2012123959A (ru) | 2013-12-20 |
BR112012011294A2 (pt) | 2015-09-15 |
AU2010319490A1 (en) | 2012-05-03 |
EP2498626A1 (en) | 2012-09-19 |
CN102595934A (zh) | 2012-07-18 |
CA2777941C (en) | 2018-08-14 |
DK2498626T3 (en) | 2015-07-13 |
US20120269865A1 (en) | 2012-10-25 |
CN104206946A (zh) | 2014-12-17 |
US9192179B2 (en) | 2015-11-24 |
US10015978B2 (en) | 2018-07-10 |
JP6205003B2 (ja) | 2017-09-27 |
IN2012DN03632A (ja) | 2015-06-26 |
JP6006117B2 (ja) | 2016-10-12 |
ES2545597T3 (es) | 2015-09-14 |
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