JP7080388B1 - 歩行機能における動的バランスの改善剤、転倒不安感の軽減剤および移動機能の低下を有する人に対する歩行機能改善剤 - Google Patents
歩行機能における動的バランスの改善剤、転倒不安感の軽減剤および移動機能の低下を有する人に対する歩行機能改善剤 Download PDFInfo
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Abstract
Description
〔1〕プロテオグリカン、II型コラーゲンおよびイミダゾールジペプチドを含む、歩行機能における動的バランスの改善剤。
〔2〕プロテオグリカン、II型コラーゲンおよびイミダゾールジペプチドを含む、転倒不安感の軽減剤。
〔3〕プロテオグリカン、II型コラーゲンおよびイミダゾールジペプチドを含む、移動機能の低下を有する人に対する歩行機能改善剤。
〔4〕ヒアルロン酸をさらに含む、〔1〕~〔3〕のいずれかに記載の剤。
〔5〕前記II型コラーゲンの含有量に対して、前記プロテオグリカンを5質量%以上20質量%以下含む、〔1〕~〔4〕のいずれかに記載の剤。
〔6〕前記イミダゾールジペプチドの含有量に対して、前記プロテオグリカンを2.0質量倍以上10質量倍以下含む、〔1〕~〔5〕のいずれかに記載の剤。
〔7〕経口剤である、〔1〕~〔6〕のいずれかに記載の剤。
〔8〕保健機能食品、健康補助食品またはサプリメントである、〔7〕に記載の剤。
〔9〕前記プロテオグリカンは、サケ鼻軟骨由来である、〔1〕~〔8〕のいずれかに記載の剤。
プロテオグリカンは、コアタンパク質とそれに結合したグリコサミノグリカン(酸性ムコ多糖)からなる糖タンパク質である。プロテオグリカンは、細胞外マトリックスの主な構成要素として、皮膚、軟骨、骨、血管壁等に存在する。
コラーゲンは、ブタなどの哺乳類、ニワトリなどの鳥類、サメ、エイなどの魚類、イカなどの軟体動物類の軟骨組織、骨、臓器、腱などに存在している。II型コラーゲン(2型コラーゲン)は特に軟骨に多く含まれる。II型コラーゲンは、加水分解されていてもよい。
イミダゾールジペプチドは、イミダゾール基を有するヒスチジンまたはヒスチジン誘導体とアミノ酸とが結合したジペプチドであり、アンセリン(β-アラニル-1-メチルヒスチジン)、カルノシン(β-アラニルヒスチジン)、バレニン(β-アラニル-3-メチルヒスチジン)、ホモカルノシン(γ-アミノブチリル-L-ヒスチジン)等が挙げられる。
ヒアルロン酸は、N-アセチルグルコサミンとグルクロン酸が二糖単位で直鎖状に結合した繰り返し構造を有し、生体内に極めて高分子で存在する。ヒアルロン酸は、生体内では関節、硝子体、皮膚、脳など広く細胞外マトリックスに存在している。ヒアルロン酸は、加水分解処理される前の高分子ヒアルロン酸であってもよいが、生体での利用効率が向上する観点からは、低分子化ヒアルロン酸であることが好ましい。低分子ヒアルロン酸は例えば平均分子量が5000以下であり、約3000であってもよい。酵素、酸またはアルカリの濃度および処理時間等を適宜選択することで、目的の分子量に調製することができる。ヒアルロン酸は、塩であってもよく、例えばナトリウム塩、カリウム塩、カルシウム塩、亜鉛塩、マグネシウム塩、アンモニウム塩であってもよい。
本発明に係る剤は、非経口剤として対象に投与してもよいが、好ましくは経口剤である。非経口投与としては、外用または静脈への投与が挙げられる。対象は、特に限定されないが、ヒトのほか、ウシ、ウマ、ブタ、ヒツジ、イヌ、トリ等の家畜や家禽、愛玩動物等であってもよい。
<研究デザイン>
無作為化二重盲検プラセボ対照並行群間比較研究
摂取期間:12週間
観察回数:3回(事前、6週目、12週目)
被験食品群:男性12名、女性14名(平均年齢53.8±7.4歳)
プラセボ群:男性13名、女性12名(平均年齢55.8±7.8歳)
下記の組成に賦形剤を加えて錠剤とした。プラセボは、下記成分を含まない以外は同じ賦形剤を用いて錠剤とした。数値は錠剤2粒(400mg)中の含有量である。1日2粒を水またはぬるま湯とともに摂取した。
プロテオグリカン(サケ鼻軟骨由来) :10mg
II型コラーゲン(鶏軟骨由来) :100mg
イミダゾールジペプチド(鶏エキス由来):2.25mg
ヒアルロン酸(微生物発酵) :10mg
有効性の評価として、TUGテスト、6分間歩行、転倒不安感尺度、2ステップテスト、膝伸展筋力測定および30秒椅子立ち上がりテストを行った。
TUGテスト(Timed Up&Go test)では、椅子から立ち上がり3m歩行し、折り返して再び着座するまでの各行程の時間を測定した。測定には、Kinesis QTUG(登録商標)タッチアンドゴーテストシステム(Kinesis Health Technologies社)を用いた。健常者の移動能力を評価するためには課題の難易度を上げる工夫が必要という先行研究(内山応信他、高齢者の易転倒性を評価するための障害物Timed Up&Goテストの提案、体育測定評価研究,8,27-32,2008.)を参考に、歩行路上の中央に障害物(高さ:10cm;奥行き:10cm;幅:1m)を設置し、触れずに跨ぐように指示した。練習を1回行った後、本番の測定を2回実施し、平均値を採用した。このテストは非常に高度なバランス機能、特に動的バランス機能が要求されるものであり、下肢筋力、歩行時のバランス能力、移動能力、転倒リスク等を評価できる(谷田惣亮他、地域高齢者の運動介入によるバランス機能の変化,佛教大学保健医療技術学部論集,5,2011.)。TUGテストで評価される能力は、日常生活機能との関連性も高い。
30mの周回路を普段の歩行と同じ速さで6分間歩行させ、距離を測定した。1回実施し、測定値は5m単位で記録した(5m未満は切り捨て)。6分間歩行テストは、歩行能力、歩行自立度、転倒リスク、移動能力、持久力、呼吸器の運動耐容能等を評価できる。
戸棚やタンスに手を伸ばす動作について、転ぶ不安を4択式で回答させた。「全く不安がない」、「少し不安がある」、「不安がある」、「とても不安がある」の回答をそれぞれ1、2、3、4点とした。
日本整形外科学会が策定したロコモ度テストのひとつである。できる限り大股で2歩歩き、2歩分の歩幅(最初に立ったラインから両足を揃えた着地点のつま先まで)を測定した。{2歩幅(cm)/身長(cm)}=2ステップ値とした。練習を2回行った後、本番の測定を2回実施し、最大値を採用した。2ステップテストは、下肢の筋力、バランス能力、柔軟性などを含めた歩行能力を総合的に評価できる。
膝伸展筋力計(テンションメーターD(竹井機器工業))を用いて、左右それぞれの最大等尺性膝伸展筋力を測定した。左右の足それぞれについて練習を2回行った後、本番の測定を2回実施し、最大値を得た。本番の測定に失敗した場合は3回目の測定を行い、失敗した測定を除く2回の測定値の最大値を採用した。最大値を体重(事前および6週目は事前の測定値、12週目は12週目の測定値)で割り、100をかけて体重比百分率を算出した。
30秒椅子立ち上がりテスト(CS-30)を実施した。40cmの高さの椅子から腕を組んだ状態で立ち上がる動作を30秒間繰り返して、立ち上がった回数を測定した。測定は1回実施した。30秒椅子立ち上がりテストは、下肢筋力、動的バランス能力等を評価できる。
TUGテストは、12週目の摂取前からの変化量について、被験食品摂取群をプラセボ摂取群と2標本t検定を用いて比較した。参考として、6週目の変化量についても同様に比較した。6分間歩行は、12週目の摂取前からの変化量について、被験食品摂取群をプラセボ摂取群とMann-WhitneyのU検定を用いて比較した。参考として6週目の変化量についても同様に比較した。転倒不安感尺度、膝伸展筋力測定は、6分間歩行と同様に評価した。
(1)ロコモではない被験者層:群間差なし
被験食品群 5名(男性2名、女性3名、56.4±8.4歳)
プラセボ食品群 5名(男性4名、女性1名、52.6±8.1歳)
(2)ロコモ度1の被験者層
被験食品群 14名(男性7名、女性7名、53.9±6.8歳)
プラセボ食品群 15名(男性8名、女性7名、57.3±8.0歳)
(3)ロコモ度2の被験者層
被験食品群 7名(男性3名、女性4名、52.0±8.5歳)
プラセボ食品群 5名(男性1名、女性4名、54.4±7.6歳)
ロコモ度1の被験者層について、プラセボ群に比べて被験食品群でTUGテストの解析項目に改善が示された。TUG recording time(TUGテスト全区間の合計タイム)は、プラセボ群に対して被験食品群で短縮幅が大きくなった(図1)。区間別のタイムについては、Time taken to stand(座った状態から立ち上がるまでのタイム)およびPre-turn time(スタートから転回動作を終えるまでのタイム)の12週目において、プラセボ群に対して被験食品群でそれぞれ有意な改善が示された(図2および図3)。Post-turn time(転回動作を終えてから着席するまでのタイム)、Time taken to turn(転回動作にかかったタイム)、およびAverage stride velocity(測定中の歩く速さの平均値)においても、12週目についてプラセボ群に対して被験食品群で改善される傾向が示された(図4、図5および図6)。
ロコモ度1の被験者層について、プラセボ群に比べて被験食品群で12週目の歩行距離の変化量が高値となり、歩行距離が増加していた(図7)。
ロコモ度1の被験者層について、プラセボ群に比べて被験食品群で6週目および12週目の膝伸展筋力(右足)の変化量が高値となった(図8)。ロコモ度1の被験者層について、プラセボ群に比べて被験食品群で12週目の膝伸展筋力(左足)の変化量が高値となった(図9)。被験食品群では、膝伸展筋力が向上していた。
ロコモ度1の被験者層について、プラセボ群に比べて被験食品群で12週目の立ち上がり回数の変化量が高値となり、立ち上がり回数が上昇していた(図10)。
ロコモ度1の被験者層について、戸棚やタンスに手を伸ばすときの転倒不安感のアンケートにおいて、プラセボ群に比べて被験食品群で6週目および12週目のポイントの変化量が有意に高値となり、転倒不安感が軽減されていた(図11)。
Claims (8)
- プロテオグリカン、II型コラーゲンおよびイミダゾールジペプチドを含み、
前記II型コラーゲンの含有量に対して、前記プロテオグリカンを5質量%以上20質量%以下含み、
ケルセチン配糖体、クレアチン類、小麦蛋白質の加水分解物、およびエラスチンペプチドを含まない、歩行機能における動的バランスの改善剤。 - プロテオグリカン、II型コラーゲンおよびイミダゾールジペプチドを含み、
前記II型コラーゲンの含有量に対して、前記プロテオグリカンを5質量%以上20質量%以下含み、
ケルセチン配糖体、クレアチン類、小麦蛋白質の加水分解物、およびエラスチンペプチドを含まない、転倒不安感の軽減剤。 - プロテオグリカン、II型コラーゲンおよびイミダゾールジペプチドを含み、
前記II型コラーゲンの含有量に対して、前記プロテオグリカンを5質量%以上20質量%以下含み、
ケルセチン配糖体、クレアチン類、小麦蛋白質の加水分解物、およびエラスチンペプチドを含まない、移動機能の低下を有する人に対する歩行機能改善剤。 - ヒアルロン酸をさらに含む、請求項1~3のいずれか1項に記載の剤。
- 前記イミダゾールジペプチドの含有量に対して、前記プロテオグリカンを2.0質量倍以上10質量倍以下含む、請求項1~4のいずれか1項に記載の剤。
- 経口剤である、請求項1~5のいずれか1項に記載の剤。
- 保健機能食品、健康補助食品またはサプリメントである、請求項6に記載の剤。
- 前記プロテオグリカンは、サケ鼻軟骨由来である、請求項1~7のいずれか1項に記載
の剤。
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JP2008237070A (ja) | 2007-03-27 | 2008-10-09 | Unitec Foods Co Ltd | 高齢者向け骨・筋肉増強促進組成物 |
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