JP2016523857A - アルツハイマー病の治療、遅延及び/又は予防において使用するための、レスベラトロール又はその誘導体を含む水産油配合物 - Google Patents
アルツハイマー病の治療、遅延及び/又は予防において使用するための、レスベラトロール又はその誘導体を含む水産油配合物 Download PDFInfo
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Abstract
Description
a)レスベラトロール及び香味剤を乳化剤と一緒に油性相に添加する工程と、
b)水溶性の添加物を水性相に添加する工程と、
c)油性相と水性相とを混合して均質なエマルションにする工程と、
d)得られたエマルションを任意選択で低温殺菌プロセス及び/又はホモジナイゼーションプロセスにかける工程と、
e)得られたエマルションを冷却し、清浄な使い捨て容器に充填する工程と
により調製することができ、すべての工程は、厳密な酸素制御下で実施される。
a)トランスレスベラトロール及び香味剤を油性相に添加する工程と、
b)水溶性の添加物を水性相に添加する工程5、
c)油性相と水性相とを混合し乳化剤を添加してから穏やかな混合を行って、均質なエマルションを得る工程5、
d)得られたエマルションを任意選択で低温殺菌プロセス及び/又はホモジナイゼーションプロセスにかける工程5、
e)得られたエマルションを冷却し、清浄な使い捨て容器に充填する工程5
によって調製することができ、すべての工程は、厳密な酸素制御下で実施される。
1日当たりそれぞれ約1000mgのEPA及びDHAと1日当たり130mgのレスベラトロールとを共にもたらす200mlのドリンク配合物を、新鮮な水産油ω-3エマルションとレスベラトロールとから調製した。
AD患者の末梢血単核細胞(PBMC)は、ベースライン時では、年齢をマッチさせた対照との比較で炎症性遺伝子のアップレギュレーション(第2群)又はダウンレギュレーション(第1群)のいずれかを示すが、すべてのAD患者のPBMCは、アミロイドβ(Aβ)により刺激されて炎症を生じる。AD患者の普遍的バイオマーカーは、マクロファージによる可溶性又は繊維性のAβの貪食能不全である。in vitroでは、ドコサヘキサエン酸(DHA)由来の脂質モジュレーターであるレゾルビンD1(RvD1)及びビタミンD3のホルモン形態である1,25ジヒドロキシビタミンD3(1,25D3)が、これらの遺伝子の脱制御能及びAβ貪食能を修復する(Mizwicki Tら、JAlz Dis、2013)。認知症対策の栄養補助食品としてDHA及びビタミンD3がしばしば摂取されるが、in vivoにおけるそれらの生化学的効果は、よくわかっていない。実施例1は、DHA及びエイコサペンタエン酸(EPA)を含む水産油を、植物(ザクロ及びチョークベリー)由来の成分、ビタミンD3、トランスレスベラトロール、乳清タンパク質単離物及び繊維との相加効果及び相乗効果を通して、酸化に対し安定化させて含むドリンク配合物である。この飲料を連日8カ月超にわたって消費していたAD患者における炎症性遺伝子転写を試験した。第1群の患者においてはIL-1βの転写は増加したが、第2群においてはIL-1βの転写は減少し、両群のマクロファージは、Aβ貪食能を回復した。ミニメンタルステート検査(MMSE)のスコアは安定化した。結論として、DHA、EPA、及びレスベラトロール誘導体を含む本発明の飲料を用いた栄養補給は、AD患者において転写異常を修正しAβ貪食能を回復することが見出された。
方法
研究母集団:患者を、本研究への登録順に一覧にしている(Table 1)(表2)。大半の対象は、コリンエステラーゼ阻害薬及び/又はNMDA阻害薬であるメマンチン等のアルツハイマー病認可薬と、自発的に本発明のドリンク配合物とを摂取していた。認知機能状態をミニメンタルステート検査(MMSE)により調べた。
本発明の配合物を摂取しているAD患者の血中単球によるアミロイドβ貪食
本発明の配合物を補給した場合の効果につき、軽度認知機能障害を含むADに罹患している患者におけるAβ貪食能及び認知機能に関して試験した[Table 2(表3)及び図10]。認知機能が正常な、年齢をマッチさせた対象におけるAβ貪食能試験の正常範囲は、平均蛍光強度(MFI)が>450、AD患者においては≦450として、これまでに確立されていた[Avagyan、Goldensonら、2009、J Neuroimmunol 210(1-2)、67〜72頁]。この研究の結果から、ベースライン時における前値を確認した。第1回来院(補給前)時の平均スコアは、認知症が進行している群(MMSE<19)では272MFI単位であり、軽度認知症又は主観的記憶愁訴を有する群(MMSE≧19)では280.5(N.S.)であった。本発明の配合物での栄養補給を受けている認知症が進行しているAD患者は、第2回来院時におけるアミロイドβの取込みが574MFI単位に増加し、軽度認知症を有する患者は、その取込みが643MFI単位に増加した。認知機能が正常な対象及び他の神経疾患を有する患者も試験した[Table 2(表3)及び図10]。
AD患者のPBMCを、マクロファージが単球から分化するまで10〜15日間培養した。発明者らは、これらのマクロファージをFAM-Aβに一晩曝露させることにより、アミロイドβ貪食能について試験した。これまでの結果と一致して、第1回来院前の血液から誘導されたAD患者のマクロファージは、Aβ貪食能がなかったが、後続の来院時におけるω-3補給後の血液から単離されたマクロファージは、大半の対象において貪食能が改善した(図11)。
認知症が進行している群(MMSE<19)においては、補給前の平均MMSEスコアは9.0であり、補給後もスコアはあまり変化しなかった(平均スコア9.5)。軽度認知機能障害を有する群(MMSE≧19)においては、補給後、MMSEスコアは23.8から27.5に増加した[Table 2(表3)]。
レスベラトロールは、細胞株においてアミロイドβのプロテアソーム分解を促進することが示された[Marambaud、Zhaoら、2005、J Biol Chem 280(45)、37377〜37382頁]。
今回、発明者らは、レスベラトロールが単球によるアミロイドβの貪食に及ぼす活性についてin vitroで試験した。本発明の配合物がin vivo補給されたAD患者番号2のPBMCを、
a)本発明の配合物、
b)レスベラトロールを含んでいない本発明の配合物、又は
c)クルクミンが添加されているb)の配合物
をin vitro補給した後にアミロイドβ試験により一晩試験した。
Claims (10)
- アルツハイマー病の治療及び/又は軽度認知機能障害(MCI)を含むアルツハイマー病に関連する症状の発現の遅延に使用するための、(i)水中油型エマルション中のtotox値15未満の新鮮な水産油と、(ii)レスベラトロール又はその誘導体とを含む配合物。
- 水産油の含有量が配合物の総質量の約0.5質量%から約10質量%であり、レスベラトロールの含有量が約0.01質量%から約0.5質量%である、請求項1に記載の配合物。
- ドリンク配合物が濃縮果汁を更に含む、請求項1又は2に記載の配合物。
- 濃縮果汁が、リンゴ濃縮汁、セイヨウナシ濃縮汁及びそれらの混合物からなる群から選択される、請求項3に記載の配合物。
- ドリンク配合物が、ザクロ及び/又はチョークベリーを更に含む、請求項4に記載の配合物。
- ドリンク配合物が、ビタミンD、ビタミンC、ビタミンB及びそれらの混合物からなる群から選択されるビタミン類を更に含む、請求項5に記載の配合物。
- アルツハイマー病の治療及び/又は軽度認知機能障害(MCI)を含むアルツハイマー病に関連する症状の発現の遅延に使用するための、(i)約0.5質量%から約10質量%の量の、水中油型エマルション中のtotox値15未満の新鮮な水産油と、(ii)約0.01質量%から約0.5質量%の量のレスベラトロール又はその誘導体と、(iii)濃縮果汁と、(iv)1種又は複数のビタミン類とを含む配合物。
- ドリンク配合物である、請求項1から7のいずれか一項に記載の配合物。
- 使用が毎日行われる、請求項8に記載の配合物。
- ドリンク配合物が50から300mlの範囲の容量を有する、請求項9に記載の配合物。
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WO2011005113A1 (en) * | 2009-07-06 | 2011-01-13 | Smartfish As | Composition comprising bioactive amino acids and/or peptides and marine oil in a stable oil-in-water emulsion, and the use of said composition as a functional or therapeutic composition |
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Cited By (1)
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US11873474B2 (en) | 2013-06-24 | 2024-01-16 | Wilson Wolf Manufacturing | Closed system device and methods for gas permeable cell culture process |
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HK1223263A1 (zh) | 2017-07-28 |
AU2014278839A1 (en) | 2015-12-10 |
ES2732307T3 (es) | 2019-11-21 |
PT3016666T (pt) | 2019-07-11 |
US9717704B2 (en) | 2017-08-01 |
US20150031653A1 (en) | 2015-01-29 |
DK3016666T3 (da) | 2019-07-01 |
MX2015016931A (es) | 2016-04-04 |
WO2014200356A1 (en) | 2014-12-18 |
AU2014278839B2 (en) | 2019-06-20 |
EP3016666A4 (en) | 2017-03-15 |
CA2914767A1 (en) | 2014-12-18 |
CN105283190A (zh) | 2016-01-27 |
EP3016666B1 (en) | 2019-05-15 |
SI3016666T1 (sl) | 2019-09-30 |
JP2019081807A (ja) | 2019-05-30 |
JP6648007B2 (ja) | 2020-02-14 |
PL3016666T3 (pl) | 2019-09-30 |
EP3016666A1 (en) | 2016-05-11 |
MX363853B (es) | 2019-04-05 |
KR20160018801A (ko) | 2016-02-17 |
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