JP2021065226A - 認知機能速度改善用の組成物 - Google Patents
認知機能速度改善用の組成物 Download PDFInfo
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Abstract
Description
本実施形態は、L−エルゴチオネインを有効成分として含有する、ヒトの脳における認知機能速度改善用の組成物(以下、「本改善用組成物」と言う場合がある。)である。本改善用組成物(認知機能速度改善用の食品組成物又は医薬組成物)は、例えば、経口的に摂取させることで、認知機能速度の改善を必要とする患者の認知機能速度改善方法に用いることができる。なお、認知機能速度とは、脳と身体が情報や物ごとを理解して反応する速さ(脳における情報処理速度など)を表し、運動量とともに、身体活動量に相関する。
本改善用組成物の製造方法(以下、「本製造方法」と言う場合がある。)について説明する。
式1:D=E×Bx×α
臨床試験の方法としては、2つの試験食品摂取群として、エルゴチオネイン摂取群(被験食品群)とプラセボ摂取群(対照群)を用いたプラセボ対照ランダム化並行群間二重盲検比較試験を採用した。なお、以下では、エルゴチオネイン摂取群を「エルゴ群」、プラセボ摂取群を「プラセボ群」と言う。
被験者の選定にあたっては、70名に対しスクリーニング調査を行い、適格基準(1)〜(11)の全てに該当し、且つ、除外基準(A)〜(D)の全てに該当しない52名を被験者に組み入れた。
(1)スクリーニング検査によるMMSEの結果が23点以上の者
(2)年齢:20歳以上80歳未満の者
(3)性別:問わない
(4)喫煙習慣のない者
(5)エルゴチオネインを多量に含む食事を摂る習慣がない者(エルゴチオネインを多量に含む食事:キノコ類、レバー、穀類、豆類)
(6)サプリメントや健康食品を常用していない者
(7)生活習慣病(高血圧、糖尿病など)やリウマチ、肝障害、腎障害、その他慢性疾患に罹患していない者
(8)悪性腫瘍、心不全、心筋梗塞の治療の既往歴がない者
(9)エルゴチオネインを多量に含むキノコ類、医薬品にアレルギー既往のない者
(10)治療を目的とした通院、投薬をしていない者
(11)臨床試験の内容を十分に理解し、文書による同意を受けている者
(A)妊娠している若しくは授乳中の女性、或いは、試験期間中に妊娠意思のある者
(B)他の治験、或いは、臨床試験に参加中の者、及び、3ヶ月以内に他の治験、或いは、臨床試験に参加した者
(C)担当医師及び医療機関スタッフの指示に従えない者
(D)その他、試験実施担当者により何らかの問題があると判断された者
各被験者は、表1に記載のスケジュールで医療機関(試験実施機関)に来院して、検査項目に記載の検査・診断・テストを行った。このスケジュールについて、摂取0週時(0w:最初の検査日)を起算日として、摂取4週時(4w:最初の検査日から28日±3日以内)、摂取8週時(8w:最初の検査日から56日±6日以内)、摂取12週時(12w:最初の検査日から84日±6日以内)にそれぞれに検査等を行った。
試験食品について、エルゴ群に対しては、タモギダケ抽出物から得たエルゴチオネイン5mg配合した食品(錠剤4粒あたり)とし、プラセボ群に対しては、エルゴチオネイン0mg配合した食品(錠剤4粒あたり)とした。各群の試験食品には、常温保存されたアルミパウチ包装のものを使用した。なお、試験食品は盲検化され、食品に割り付けられた識別番号を元に被験者に渡した。盲検化の対象は、試験に関係する者(被験者、介入実施者、評価者など)全員であり、解析対象被験者が固定されるまで、割付表は開封しないこととした。
統計手法としては、群間比較ではStudent’s t-testにて評価した。摂取前値との比較による群内比較では対応のあるt検定を行った。有意水準は両側5%とした。解析データには、各データにおける実測値および変化量を使用した。統計解析ソフトとしては、StatMate V(株式会社アトムス)を用いた。
表2には、エルゴ群とプラセボ群のそれぞれについて、被験者のエルゴチオネイン血中濃度の平均値の変化を示す。表2によれば、エルゴ群では、試験食品の摂取によるエルゴチオネイン血中濃度の増加が確認できた。一方、プラセボ群では、試験食品の摂取によるエルゴチオネイン血中濃度の増加は確認できなかった。
図1〜図13に、コグニトラックス検査における13つの項目について、実線でPPS症例解析の結果、波線で層別解析の結果を示し、太線でエルゴ群、細線でプラセボ群を示す。つまり、太線の実線は「PPS症例解析におけるエルゴ群の結果」、細線の実線は「PPS症例解析におけるプラセボ群の結果」、太線の波線は「層別解析におけるエルゴ群の結果」、細線の波線は「層別解析におけるプラセボ群の結果」を示す。なお、各図の凡例において、PPS症例解析の結果を「PPS」、層別解析の結果を「層別」と表す。
Claims (12)
- L−エルゴチオネインを有効成分として含有する、認知機能速度改善用の組成物。
- 前記L−エルゴチオネインがタモギダケ抽出物に含有されている、請求項1に記載の組成物。
- 前記L−エルゴチオネインの摂取量が、成人1人1日当たり1mg〜30mgである、請求項1又は2に記載の組成物。
- タモギダケ抽出物を有効成分として含有する、認知機能速度改善用の組成物。
- 前記認知機能速度として、脳における情報処理速度を改善する、請求項1乃至4の何れか1つに記載の組成物。
- 前記認知機能速度に加え、加齢に伴う言語記憶力の低下を改善する、請求項1乃至5の何れか1つに記載の組成物。
- 前記認知機能速度に加え、加齢に伴う持続的注意力の低下を改善する、請求項1乃至6の何れか1つに記載の組成物。
- 前記認知機能速度に加え、加齢に伴う単純注意力の低下を改善する、請求項1乃至7の何れか1つに記載の組成物。
- 当該組成物が食品組成物である、請求項1乃至8の何れか1つに記載の組成物。
- 前記食品組成物が、健康食品、機能性食品、栄養補助食品、サプリメント、特定保健用食品、病者用食品・病者用組合わせ食品又は高齢者用食品である、請求項9に記載の組成物。
- 当該組成物が医薬組成物である、請求項1乃至8の何れか1つに記載の組成物。
- 当該組成物が、タモギタケエキスからなる組成物、フリーズドライされた組成物、又はスプレードライされた組成物である、請求項1乃至11の何れか1つに記載の組成物。
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WO2023079954A1 (ja) * | 2021-11-08 | 2023-05-11 | 三菱瓦斯化学株式会社 | 内耳性難聴の抑制又は予防のためのエルゴチオネインを含む組成物 |
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