JP2020037540A - 認知機能の維持又は軽度認知障害の改善のための緑茶組成物 - Google Patents
認知機能の維持又は軽度認知障害の改善のための緑茶組成物 Download PDFInfo
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Abstract
Description
また、薬剤、サプリメント、飲食品等の経口摂取によって脳機能の改善を目指す場合、前提となる問題として、それらに含まれる成分の体内への吸収があり、如何に有効な成分であっても、消化器官において成分が良好に吸収されなければ意味がない。従って、経口摂取による場合、有効成分の体内への吸収は、避けられない問題となる。
緑茶成分として、抹茶(商品名:宝尽の白、テアニン含有量:2.4質量%、EGCG含有量:5.3質量%、カテキン類8種合計量:8.4質量%、カフェイン含有量:3.5質量%)を用意した。2gの抹茶を0.6gの賦形剤(部分α化デンプン、デキストリン、ステアリン酸カルシウム、微粒二酸化ケイ素の混合物)に添加して混合し、この混合物を9個のゼラチンカプセルに均等に分けて充填することによって、1回の摂取分のサンプルを調製した。
また、2gの賦形剤(同上)にクチナシ色素を添加して緑色に色付けし、これを9個のゼラチンカプセルに均等に分けて充填することによって、1回の摂取分のプラセボを調製した。
認知機能の低下を自覚している88名の中高年(50歳以上69歳以下)の被験者について、スクリーニングとしてMMSE検査を実施した。尚、MMSE検査の「注意と計算」の項目では、シリアル7課題及び逆唱課題の両方を選択した。MMSE検査のスコア得点が22点以上(逆唱課題の点数を除き、シリアル7課題の得点を含んだ点数)の被験者77名について、得点の低い方から順に62名(得点:22〜30点)を選抜し、以下の評価方法を実施する被験者に選定した。62名の被験者について、身長、体重、脈拍及び血圧の測定を行い、被験者背景調査及び問診を行った。更に、62名の被験者を、平均年齢、性別比、MMSE検査の平均得点を割り付け因子として2つの群に振り分けて、サンプル群及びプラセボ群を31名の被験者によって各々構成した。この群構成に基づいて、ITT(Intent To Treat)解析により、下記の評価検査を行った。尚、プラセボ群は、被験者2名が体調不良により途中脱落し、29名となった。各群の被験者構成は表1に記載する。
サンプル群及びプラセボ群の被験者に、コグニトラックス検査(CNS Vital Signs社提供)の10種のテストを行って、認知機能の評価を行った。各テストの内容は以下の通りである。各テストの結果について、応答数は、被験者間の平均値±標準偏差で示し、反応時間については、被験者の1応答当たりの反応時間から算出される被験者間の平均値±標準偏差で示す。
15の図形が2秒に1つの割合で画面に表示され、その後、新たな15の図形と共に既出の図形が表示され、既出の図形を回答する。所定数(所要時間約3分)のテストの正解回答数を測定する。
(1)単語(赤、青、黄)がランダムに黒色表示され、表示を見たら直ぐ応答し、所定回数の応答に要する時間(単純反応時間[ミリ秒])を測定する。(2)単語(赤、青、黄、緑)がランダムに色表示され、単語を表示する色と単語の意味が一致した時のみ、又は、意味が一致しない時のみに応答する。所定数(所要時間約5分)のテストにおいて、誤った応答の数(ストループ誤反応)を測定する。
図形(丸、三角)が、画面の上部に1つ、下部に2つ表示され(色はランダムに赤又は青)、上部の表示と同じ図形又は同じ色の表示を下部から選択して応答する。所定数(所要時間約3分)のテストにおける正解応答及び誤答の数、並びに、正解応答における反応時間(正解反応時間[ミリ秒])を測定する。
画面に表示される顔の表情が、その下に表示される感情との一致について正否を応答する。2分間のテストにおいて、反応時間[ミリ秒]を測定する。肯定反応及び否定反応の各場合における正解応答数、反応時間、並びに、肯定反応及び否定反応の正解応答数の合計、平均正解反応時間、正解見過ごし数の合計、誤反応の合計を算出する。
画面の4つの区分のうちの3つに表示される図から、空いた区分に入るべき図を推論し、選択肢から選んで応答する。所定数(所要時間約3.5分)のテストにおける正解応答及び誤反応の数を測定する。
(1)パート1:画面にランダムに文字が表示される間に、特定の文字が表示されたら即時応答し、正解応答における応答時間[ミリ秒]を測定し、平均値を算出する。(2)パート2:画面にランダムに図が表示される間に、特定の図が表示されたら即時応答し、正解応答における応答時間を測定し、平均値を算出する。(3)画面にランダムに図が表示される間に、1つ前の図が表示されたら即時応答し、正解応答における応答時間を測定し、平均値を算出する。(4)画面にランダムに図が表示される間に、2つ前の図が表示されたら即時応答し、正解応答における応答時間を測定し、平均値を算出する。
画面にランダムに文字が表示される間に、特定の文字が表示されたら即時応答し、所定のテスト(所要時間約5分)における誤反応の数を測定し、平均値を算出する。
15の単語が2秒に1つの割合で画面に表示され、その後、新たな15の単語と共に既出の単語が表示され、既出の単語を回答する。所定数(所要時間約3分)のテストの正解回答数を測定する。
右手の人差し指でキーを10秒間できる限り速く叩く。1回の練習後に3回実施し、左手の人差し指で同じ作業を繰り返す。キーを叩いた回数を測定し、3回の平均値を得る。
画面の上部に、8つのシンボルと8つの数字とを対応させて表記する表を表示し、画面の下部に、8つのシンボルと空欄とを有する表を表示する。上部の表の対応関係に従って、下部の表の各シンボルに対応する数字で空欄を埋める作業における応答時間[ミリ秒]を測定し、所定数(所要時間約4分)のテストの正解応答及び誤答の数及び反応時間を調べる。
この後、上述のサンプル又はプラセボを、サンプル群及びプラセボ群の各々の被験者に提供し、サンプル(又はプラセボ)9個を1日に1回、午前中に摂取してもらい、これを12週間継続した。この摂取期間中において、4週間、8週間及び12週間の各時点で、コグニトラックス検査の10種のテストを再度行って、認知機能を検査した。検査結果において効果が認められるものを表2に示す。検査結果の評価は、t検定またはマンホイットニーのU検定による。
また、12週間の摂取を終了した時点で、MMSE検査を再度行って、認知機能を検査した。結果を表3に示す。
Claims (5)
- 緑茶葉粉末と、賦形剤とを含有し、前記緑茶葉粉末は、テアニンの含有量が1.0〜4.0質量%、カテキン類の含有量が5.0〜12.5質量%、カフェインの含有量が2.5〜5.0質量%である、健常者認知機能の維持又は軽度認知障害の改善のための緑茶組成物。
- 前記緑茶葉粉末を、全体の10〜90質量%の割合で含有する請求項1に記載の健常者認知機能の維持又は軽度認知障害の改善のための緑茶組成物。
- 前記緑茶葉粉末は、抹茶である請求項1又は2に記載の健常者認知機能の維持又は軽度認知障害の改善のための緑茶組成物。
- 前記賦形剤は、コーンスターチ、ゼラチン、部分α化デンプン、デキストリン、ステアリン酸カルシウム及び微粒二酸化ケイ素から選択される少なくとも一種を含む請求項1〜3の何れか一項に記載の健常者認知機能の維持又は軽度認知障害の改善のための緑茶組成物。
- 前記緑茶葉粉末に含有されるカテキン類に占めるエピガロカテキンガレートの割合は、0.5〜0.8である請求項1〜4の何れか一項に記載の健常者認知機能の維持又は軽度認知障害の改善のための緑茶組成物。
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