JP6637587B2 - 副鼻腔炎に対するイヌリンの予防的使用 - Google Patents
副鼻腔炎に対するイヌリンの予防的使用 Download PDFInfo
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- JP6637587B2 JP6637587B2 JP2018504983A JP2018504983A JP6637587B2 JP 6637587 B2 JP6637587 B2 JP 6637587B2 JP 2018504983 A JP2018504983 A JP 2018504983A JP 2018504983 A JP2018504983 A JP 2018504983A JP 6637587 B2 JP6637587 B2 JP 6637587B2
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Description
本発明の文脈において、炭水化物の全質量に基づく、DP≧11である化合物の乾燥分中の重量%は、Joye & Hoebregs、J. AOAC International、83巻、4号、2000年、1020〜1025頁に開示されるように、乾燥炭水化物の全量、及びDPが10を含めて最大10の乾燥化合物の全量を高温キャピラリーガスクロマトグラフィー(HGC)により測定し、前記測定からDP≧11である化合物の合計の重量%を計算することによって決定される。
本発明の文脈において、「DP」(重合度)という用語は、イヌリン分子中、すなわちオリゴ糖又は多糖中に存在するグルコース及びフルクトース単位の数で表されるイヌリン鎖長を表す。
・ [AOACによるFi]から[HGCによるFm化合物の合計]を引いて[GFnに起因するFi]を得る。
・ [GFnに起因するFi]を[Gi]で割って1をプラスすると、本発明の組成物のGFnの部分におけるDPavを得る。
・ HGCにより個々のFm化合物の量を決定すると本発明の組成物のFmの部分におけるDPavを直接計算できる。
・ 2つのDPav数を合わせて混合物の全体のDPavを得る。
A)本発明によるプレバイオティクスイヌリン組成物の効果について、二重盲検、並行、無作為、及びプラシーボ対照による試験を3〜6歳の子供に行った。Nutritional Research Unitにおいて試験を行い、前記混合物の投与が副鼻腔炎エピソードのリスクを低下させるのに役立つかどうかを調べた。子供は彼らの両親の同意及び許可のもとでこの試験に参加した。
・ 正規分布についてのシャピロ・ウィルク検定、
・ 定量的変数、身体測定値、並びに感染症の発生率及び持続期間についてのマン・ホイットニー検定、
・ パーセンテージとして表される変数について、並びに特定の急性疾患の発生率及び抗生物質の処方率を有する子供の割合の比較についての、ピアソンのカイ二乗検定
本発明は以下の態様も提供する。
[1] GF n -及びF m -化合物を含むイヌリン組成物であって、25〜40重量%(乾燥分、炭水化物の全質量に基づく)のDP(重合度)≧11である化合物と、15〜30重量%(乾燥分、炭水化物の全質量に基づく)のm=2〜9であるF m 化合物とを含み、DP AV (平均重合度)が6.5〜9である、イヌリン組成物。
[2] それを必要とする対象において副鼻腔炎のリスクを低下させるための、[1]に記載のイヌリン組成物。
[3] それを必要とする対象の群においてプラシーボで治療された対象の群と比較して副鼻腔炎のリスクが少なくとも33%低下する、[2]に記載のイヌリン組成物。
[4] それを必要とする対象における副鼻腔炎の予防に使用するための、[1]に記載のイヌリン組成物。
[5] それを必要とする対象が、年齢が少なくとも3歳であるヒトである、[2]から[4]のいずれかに記載のイヌリン組成物。
[6] それを必要とする対象が、年齢が3〜6歳であるヒトである、[2]から[5]のいずれかに記載のイヌリン組成物。
[7] 30〜38重量%(乾燥分、炭水化物の全質量に基づく)のDP≧11である化合物を含む、[1]から[6]のいずれかに記載のイヌリン組成物。
[8] 20〜28重量%(乾燥分、炭水化物の全質量に基づく)のm=2〜9であるF m 化合物を含む、[1]から[7]のいずれかに記載のイヌリン組成物。
[9] DP AV が7〜8である、[1]から[8]のいずれかに記載のイヌリン組成物。
[10] 50〜70重量%、好ましくは55〜65重量%の、DPが3〜10であるGF n -及びF m -化合物と、30〜40重量%、好ましくは35〜39重量%の、DP≧11であるGF n -化合物とを含む(それぞれ乾燥分に基づき、炭水化物の全質量に基づく)、[1]から[9]のいずれかに記載のイヌリン組成物。
[11] 80〜99%のGF n -及びF m -化合物と、1〜20%の単糖及びスクロースとを含む(それぞれ乾燥分の重量、及び炭水化物の全質量に基づく)、[1]から[10]のいずれかに記載のイヌリン組成物。
[12] 5〜15g/日の投与量で成人において使用するための、[1]から[11]のいずれかに記載のイヌリン組成物。
[13] 2.5〜15g/日の投与量で子供において使用するための、[1]から[12]のいずれかに記載のイヌリン組成物。
[14] 1〜8か月の投与期間にわたって使用するための、[1]から[13]のいずれかに記載のイヌリン組成物。
[15] [1]から[14]のいずれかに記載のイヌリン組成物を含む、食品、飲料、又は医薬組成物。
Claims (13)
- それを必要とする対象において副鼻腔炎のリスクを低下させるための、GFn-及びFm-化合物を含むイヌリン組成物であって、25〜40重量%(乾燥分、炭水化物の全質量に基づく)のDP(重合度)≧11である化合物と、15〜30重量%(乾燥分、炭水化物の全質量に基づく)のm=2〜9であるFm化合物とを含み、DPAV(平均重合度)が6.5〜9である、イヌリン組成物。
- それを必要とする対象の群においてプラシーボで治療された対象の群と比較して副鼻腔炎のリスクが少なくとも33%低下する、請求項1に記載のイヌリン組成物。
- それを必要とする対象が、年齢が少なくとも3歳であるヒトである、請求項1又は2のいずれか一項に記載のイヌリン組成物。
- それを必要とする対象が、年齢が3〜6歳であるヒトである、請求項1から3のいずれか一項に記載のイヌリン組成物。
- 30〜38重量%(乾燥分、炭水化物の全質量に基づく)のDP≧11である化合物を含む、請求項1から4のいずれか一項に記載のイヌリン組成物。
- 20〜28重量%(乾燥分、炭水化物の全質量に基づく)のm=2〜9であるFm化合物を含む、請求項1から5のいずれか一項に記載のイヌリン組成物。
- DPAVが7〜8である、請求項1から6のいずれか一項に記載のイヌリン組成物。
- 50〜70重量%、好ましくは55〜65重量%の、DPが3〜10であるGFn-及びFm-化合物と、30〜40重量%、好ましくは35〜39重量%の、DP≧11であるGFn-化合物とを含む(それぞれ乾燥分に基づき、炭水化物の全質量に基づく)、請求項1から7のいずれか一項に記載のイヌリン組成物。
- 80〜99重量%のGFn-及びFm-化合物と、1〜20重量%の単糖及びスクロースとを含む(それぞれ乾燥分の重量、及び炭水化物の全質量に基づく)、請求項1から8のいずれか一項に記載のイヌリン組成物。
- 5〜15g/日の投与量で成人において使用するための、請求項1から9のいずれか一項に記載のイヌリン組成物。
- 2.5〜15g/日の投与量で子供において使用するための、請求項1から10のいずれか一項に記載のイヌリン組成物。
- 1〜8か月の投与期間にわたって使用するための、請求項1から11のいずれか一項に記載のイヌリン組成物。
- 請求項1から12のいずれか一項に記載のイヌリン組成物を含む、それを必要とする対象において副鼻腔炎のリスクを低下させるための食品、飲料、又は医薬組成物。
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