JP7091344B2 - アミロース分解活性および短鎖脂肪酸産生微生物の活性を促進するためのプレバイオティクス栄養補助食品 - Google Patents
アミロース分解活性および短鎖脂肪酸産生微生物の活性を促進するためのプレバイオティクス栄養補助食品 Download PDFInfo
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Description
本出願は、2018年1月12日に出願された米国特許出願15/869,032号の優先権および全ての利益を主張し、それは2017年1月13日に出願された米国仮特許出願第62/446,042号の優先権および全ての利益を主張し、その内容は、参照により本明細書に組み込まれる。
本実施形態は、一般に、ヒト対象のGI系においてアミロース分解活性および短鎖脂肪酸(SCFA)産生微生物の活性を促進することにより、ヒト対象の胃腸(GI)の健康を改善するための組成物および方法に関する。組成物は、異なる種類の微生物叢が利用可能な炭水化物(MACs)の混合物、そしてより具体的には少なくとも二つの異なる難消化性デンプンおよび少なくとも二つの異なる非デンプン多糖類の混合物を含みうる。
ヒトの胃腸(GI)系は、宿主の消化器系、免疫系、および代謝の健康を含む、宿主の健康の多様な側面に関連するGI微生物叢を形成する様々な微生物細胞を含む。食事、抗生物質、および病気を含む、様々な要因がヒトのGI微生物叢に影響を与える可能性がある。微生物叢腸内毒素症は、様々な疾患、たとえばメタボリックシンドローム、炎症性腸疾患、およびがんと関連している。したがって、GI微生物叢を操作することは、疾患を治療および/または予防するために使用することができると考えられている。
組成物、ブレンド、および方法を開示する。組成物、ブレンド、および方法は、短鎖脂肪酸(SCFA)を産生するアミロース分解性微生物の活性を促進することにより、ヒト対象の胃腸(GI)の健康を改善するのに有用である。様々な実施形態では、方法、ブレンド、および組成物はアミロース分解性および酢酸生成性および/または酪酸生成性の微生物の活性を促進する。方法、ブレンド、および組成物はまた、特にヒト対象の結腸における、ヒト対象のGI内のクロストリジウム科(Clostridiaceae)、放線菌門(Actinobacteria)、および/またはバクテロイデス門(Bacteroidetes)に属する分類群の嫌気性発酵槽の活性を促進するのに有用である。組成物、ブレンド、および方法はまた、SCFAsを産生する微生物の活性を刺激する微生物叢が利用可能な炭水化物(MACs)の複数の源を提供することにより、各ヒト対象のGI微生物叢の個人内のおよび個人間の変動を軽減しうる。組成、ブレンド、および方法はまた、GI系内の複数の場所でアミロース分解性およびSCFA産生微生物を促進しうる。組成、ブレンド、および方法は、腸管壁浸漏に関連する腸の透過性も低下させうる。本明細書では、他の潜在的な非限定的な利点について説明する。
三つの異なる難消化性デンプン、および三つの異なる非デンプン多糖類を含むMAC混合物を、追加の不活性成分とブレンドし、乾燥チョコレートシェイクミックス組成物(「シェイクミックスA」)を形成した。甘味剤、香味剤、および他の不活性成分を含むシェイクミックスA組成物は、組成物と水の混合を促進して、ヒト対象による摂取のためのチョコレートシェイクテイスティング飲料を形成するように処方される。以下の表1はシェイクミックスAの成分およびその相対量を明らかにする。シェイクミックスAは、組成物とともに提供される計量容器を使用して、粉末の一杯分に対応する用量で、1用量あたり合計15グラムのMACsを提供するように処方できる。シェイクミックスAは、いくつかの要因、たとえばSCFA産生およびGI耐容性の所望のレベルに応じて、1日に1回または2回以上、ヒト対象によって摂取されてもよい。
4つの異なる難消化性デンプン、および2つの異なる非デンプン多糖類を含むMAC混合物を、追加の不活性成分とブレンドして、乾燥チョコレートシェイクミックス組成物(「シェイクミックスB」)を形成した。甘味剤および香味剤を含むシェイクミックスB組成物は、組成物と水の混合を促進して、ヒト対象による摂取のためのチョコレートシェイクテイスティング飲料を形成するように処方される。以下の表2はシェイクミックスBの成分およびその相対量を明らかにする。シェイクミックスBは、組成物とともに提供される計量容器を使用して、粉末の一杯分に対応する用量で、1用量あたり合計19グラムのMACsを提供するように処方できる。シェイクミックスBは、いくつかの要因、たとえばSCFA産生およびGI耐容性の所望のレベルに応じて、1日に1回または2回以上、ヒト対象によって摂取されてもよい。
毎日8週間摂取された実施例1の混合物がヒトGI微生物叢の組成、多様性、および/または機能を調節するかどうかを実証するため、ランダム化比較クロスオーバー試験が完了した。副次的目的は、皮膚および口腔の微生物叢、顔の皮膚の特徴、GI微生物叢代謝物の産生、ならびに以下で詳細に説明する特定の健康パラメータで観察される二次的変化を調べることであった。
1日目=朝に一杯分の製品;
2日目=朝に一杯分の製品;
3日目=朝に一杯分の製品、および夜に一杯分の製品;
4日目=朝に一杯分の製品、および夜に一杯分の製品;および
5日目=朝に一杯分の製品、午後に一杯分の製品、および夜に一杯分の製品。
1.腫瘍壊死因子(TNF)アルファが減少した;
2.皮膚の赤色斑が減少した;
3.食欲および軽食への衝動が減少した;
4.LDLコレステロール、非HDLコレステロール、および総コレステロールが減少した;
5.糞便の固さおよび排便の容易さが改善された;および
6.GIガスは増加したが、けいれんおよび膨満(bloating)は優位な効果を示さなかった。
実施例1は、ヒトの胃腸(GI)微生物叢を治療するための組成物に関し、この組成物は、少なくとも二つの異なる難消化性デンプン、および少なくとも二つの異なる非デンプン多糖類;ならびに一つまたは複数の薬学的に許容される添加物;を含む微生物叢が利用可能な炭水化物(MACs)の混合物を含む。ここでMACsの混合物は、ヒトのGI系におけるアミロース分解性および短鎖脂肪酸(SCFA)産生性微生物の活性を促進する。
Claims (12)
- ヒトの胃腸(GI)の微生物叢を操作するための組成物であって、
微生物叢が利用可能な炭水化物(MACs)の混合物であって
エンドウデンプン、ジャガイモデンプン、生青バナナデンプン、およびヤーコンデンプンからなる群から選択される、少なくとも三つの異なる難消化性デンプン、および
グルコマンナン、アカシアガム、およびグアーガムからなる群から選択される、少なくとも二つの異なる非デンプン多糖類
を含む混合物;および
一つまたは複数の薬学的に許容される添加剤;
を含み、
ここで組成物をヒトに経口投与した後、MACsの混合物はヒトのGI管においてアミロース分解活性および短鎖脂肪酸(SCFA)産生微生物の活性を促進し;
ここで該難消化性デンプンの少なくとも一つは、A型デンプン粒を含む;および
ここで該難消化性デンプンの少なくとも一つは、B型デンプン粒を含む、
組成物。 - 前記少なくとも三つの異なる難消化性デンプンは、少なくともエンドウデンプン、ジャガイモデンプン、および生青バナナデンプンを含む、請求項1に記載の組成物。
- 前記少なくとも三つの異なる難消化性デンプンは、i)生青バナナデンプン;およびii)エンドウデンプン、ジャガイモデンプン、およびヤーコンデンプンからなる群から選択される少なくとも二つの異なる難消化性デンプンからなる、請求項1に記載の組成物。
- 前記異なる非デンプン多糖類は、少なくともグルコマンナンおよびアカシアガムを含む、請求項1~3のいずれか一項に記載の組成物。
- 前記異なる難消化性デンプンのそれぞれは、前記異なる非デンプン多糖類のそれぞれの量の少なくとも二倍で前記組成物中に存在する、請求項1~4のいずれか一項に記載の組成物。
- 前記MACsの混合物は、ヒトの結腸に存在するクロストリジウム科(Clostridiaceae)、放線菌門(Actinobacteria)、およびバクテロイデス門(Bacteroidetes)に属する分類群に属する個々の微生物のアミロース分解活性およびSCFA産生活性を促進する、請求項1~5のいずれか一項に記載の組成物。
- 前記MACsの混合物は、
前記少なくとも三つの異なる難消化性デンプン;および少なくともグルコマンナン(glucomannon)およびアカシアガムが存在する、前記少なくとも二つの異なる非デンプン多糖類からなる、請求項1~6のいずれか一項に記載の組成物。 - 前記MACsの混合物は、
エンドウデンプン、ジャガイモデンプン、および生青バナナデンプンからなる三つの異なる難消化性デンプン;および
グルコマンナン、アカシアガム、およびグアーガムからなる、三つの異なる非デンプン多糖類
からなる、請求項1~6のいずれか一項に記載の組成物。 - それぞれが前記組成物の総重量に基づき、前記三つの異なる難消化性デンプンは、15~20重量%の量で個別に存在し、前記三つの異なる非デンプン多糖類は、1~5重量%の量で個別に存在する、請求項8に記載の組成物。
- 前記MACsの混合物は、
エンドウデンプン、ジャガイモデンプン、生青バナナデンプン、およびヤーコンデンプンからなる四つの異なる難消化性デンプン;および
グルコマンナンおよびアカシアガムからなる、二つの異なる非デンプン多糖類
からなる、請求項1~6のいずれか一項に記載の組成物。 - それぞれが前記組成物の総重量に基づき、前記四つの異なる難消化性デンプンが15~20重量%の量で個別に存在し、前記二つの異なる非デンプン多糖類が1~10重量%の量で個別に存在する、請求項10に記載の組成物。
- それぞれが前記組成物の総重量に基づき、前記非デンプン多糖類の一つが1~5重量%の量で存在し、他の前記非デンプン多糖類が5~10重量%の量で存在する、請求項11に記載の組成物。
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