JPWO2017154865A1 - 女性特有の身体的及び/又は精神的不快症状の改善剤 - Google Patents
女性特有の身体的及び/又は精神的不快症状の改善剤 Download PDFInfo
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Abstract
Description
[1]γ−トコフェロール及びエクオールを含む女性特有の身体的及び/又は精神的不快症状の改善剤、
[2]γ−トコフェロールとエクオールとがそれぞれ別個の剤として含まれる、[1]記載の改善剤、
[3]γ−トコフェロールとエクオールとが同一の剤として含まれる、[1]記載の改善剤、
[4]前記女性特有の身体的及び/又は精神的不快症状が、痛み、否定的感情、集中力、及び行動の変化からなる群から選択される1つ以上である、[1]〜[3]に記載の改善剤、
[5]前記女性特有の身体的及び/又は精神的不快症状が、月経前及び/又は月経中の身体的及び/又は精神的不快症状である、[1]〜[4]のいずれかに記載の改善剤、
[6]γ−トコフェロールとエクオールの配合割合(総量の重量比)が1:0.0001〜1:500である、[1]〜[5]のいずれかに記載の改善剤、
[7]エクオールとして、エクオール含有大豆胚軸発酵物を含む、[1]〜[6]のいずれかに記載の改善剤、
[8]γ−トコフェロールの1日摂取量が0.1〜1000mg、及びエクオールの1日摂取量が0.1〜50mgになるように摂取するための、[1]〜[7]のいずれかに記載の改善剤、
[9][1]〜[8]のいずれかに記載の改善剤を含む飲食品、
[10]飲食品の形態である、[1]〜[8]のいずれかに記載の改善剤、
[11]γ−トコフェロールを含む女性特有の身体的及び/又は精神的不快症状の改善剤、
[12]女性特有の身体的及び/又は精神的不快症状が、痛み、否定的感情、集中力、及び行動の変化からなる群から選択される1つ以上である、[11]に記載の改善剤、
[13]女性特有の身体的及び/又は精神的不快症状が、月経前及び/又は月経中の身体的及び/又は精神的不快症状である、[11]又は[12]に記載の改善剤、
[14]γ−トコフェロールの1日摂取量が0.1〜1000mgになるように摂取するための、[11]〜[13]のいずれかに記載の改善剤、
[15][11]〜[14]のいずれかに記載の改善剤を含む飲食品、
[16]飲食品の形態である、[11]〜[14]のいずれかに記載の改善剤、
[17]エクオールを含む女性特有の身体的及び/又は精神的不快症状の改善剤、
[18]女性特有の身体的及び/又は精神的不快症状が痛み、否定的感情、集中力、及び行動の変化からなる群から選択される1つ以上である、[17]に記載の改善剤、
[19]女性特有の身体的及び/又は精神的不快症状が、月経前及び/又は月経中の身体的及び/又は精神的不快症状である、[17]又は[18]に記載の改善剤、
[20]エクオールとして、エクオール含有大豆胚軸発酵物を含む、[17]〜[19]のいずれかに記載の改善剤、
[21]エクオールの1日摂取量が0.1〜50mgになるように摂取するための、[17]〜[20]のいずれかに記載の改善剤、
[22][17]〜[21]のいずれかに記載の改善剤を含む飲食品、及び
[23]飲食品の形態である、[17]〜[21]のいずれかに記載の改善剤
を提供する。
(1)女性特有の身体的及び/又は精神的不快症状の改善剤(以下「本発明の改善剤」)を提供する。
(2)特に、月経前及び/又は月経中の身体的及び/又は精神的不快症状の改善剤を提供する。
(3)手軽に摂取できるタイプの本発明の改善剤を提供することができる。
γ−トコフェロール360mgを含有するソフトカプセル、及びエクオール1mgを含む大豆胚軸発酵物及びカルシウム125mgを含有する錠剤を、適量のカプセル基剤、賦形剤等を用いて常法により製剤化した。なお、エクオール含有大豆胚軸発酵物は、国際公開第WO2007/066655号に記載の方法により製造した。カプセル1粒及び錠剤2錠を一組とした。
月経前に水分貯留を有する者25名を対象に、無作為割付プラセボ対照二重盲検試験化群間比較試験を実施した。被験物として、γ−トコフェロール90mgを含むソフトカプセル1日4粒(すなわち、γ−トコフェロールの1日量は360mg)又はプラセボカプセル1日4粒を、朝、晩に2錠ずつ、月経開始10〜7日前から7日間、継続摂取した。評価期間は、継続摂取6日目の朝から、摂取終了後8日目の朝であり、毎食前にアンケート評価を実施し、評価開始時からの変化量の平均値を求めることで、プラセボ群と比較した。
アンケート評価はVAS(Visual Analog Scale)および、MDQ(Menstrual Distress Questionnarie(月経随伴症状アンケート))により行った。それぞれの質問項目は表1および表2に示す。
なお、VASは、それぞれの質問について被験者に症状を「0mm」(症状なし)〜「100mm」(症状が非常に強い/日常生活に影響がある)のスケールで示してもらい、評価開始時からの変化量の平均値を求めることにより算出した。MDQは、被験者に、それぞれの質問について「0」(症状なし)〜「5」(症状が非常に強い/日常生活に影響がある)の6段階で回答させ、表2に示す8つのカテゴリーに分けて、スコアの合計を算出した。
γ−トコフェロール単独試験の結果を図1に示す。γ−トコフェロール単独試験は、プラセボに比べてスコアが減少した人の割合を示す。γ−トコフェロール単独摂取により、γ−トコフェロール服用群では、足のむくみ等の身体的不快症状の改善だけでなく、「イライラ・怒りやすさ」という精神的不快症状もプラセボに比して有意に改善した。
γ−トコフェロール単独試験により、γ−トコフェロール服用群でのプラセボに比べてスコアが減った人の割合が、「水分貯留」の項目が56.0%、「痛み」の項目が44.0%、「否定的感情」の項目が28.0%、「集中力」が36.0%、「行動の変化」が32.0%と高い改善率を示した。
月経前に何かしら不快症状を有する者25名を対象に、被験物(1日量としてγ−トコフェロール360mg含むソフトカプセルを1粒と、エクオール1mgを含有する大豆胚軸発酵物、鉄2mg及びカルシウム125mgを含む錠剤を2錠(すなわち、エクオール、鉄及びカルシウムの1日量はそれぞれ、2mg、4mg及び250mg))を1日1回、月経開始予定の10日〜7日前から7日間の継続摂取を実施した。
被験物摂取前、及び7日間の継続摂取終了後、月経前の症状をMDQで評価した。MDQは試験例1に記載の通りである。また、生理前と生理中の全体的な改善度を、「いつもに比べて症状が軽かった」、「変わらなかった」、「悪化した」の3段階で評価した。さらに、被験物の摂取前後の月経前の症状、及び継続摂取終了後の月経期間中の症状について、アンケート調査を行った。
25名中11名について、月経前にMDQを実施し、被験物の摂取前に比して摂取後のスコアが減少したヒトの割合を算出した。他の14名については、途中で月経が開始したため、月経前にMDQを実施できなかった。
γ−トコフェロールとエクオールを含む被験物を服用すると、摂取前と比較してスコアが減少したヒトの割合が、「水分貯留」の項目が54.5%、「痛み」の項目が63.6%、「否定的感情」の項目が60.0%、「集中力」の項目が54.5%、「行動の変化」の項目が60.0%であった。
図2に試験例1の結果2と試験例2の結果1のMDQの比較を示す。特に、「痛み」、「否定的感情」、「集中力」及び「行動の変化」の4つのカテゴリーについて、γ−トコフェロール単独よりも、γ−トコフェロール及びエクオールの組み合わせを投与した場合に症状が改善した人の割合が増加した。また、試験例1と試験例2の結果より、エクオール単独でも「痛み」、「否定的感情」、「集中力」、「行動の変化」について効果があることも示唆された。
被験者25名について、被験物摂取による生理前及び生理中症状の全体的な改善度を、「いつもに比べて症状が軽かった」、「変わらなかった」、「悪化した」、の3段階で評価した。結果を図3に示す。図3から明らかなように、γ−トコフェロール及びエクオールの組み合わせを摂取した場合、被験者の半数以上(生理前68.0%、生理中52.0%)において、生理前および生理中における不快症状が改善された。
アンケート調査の結果によると、生理前、生理中の肌荒れがなく、生理前に必ずできるニキビができなかったという意見もあった。
Claims (21)
- γ−トコフェロール及びエクオールを含む女性特有の身体的及び/又は精神的不快症状の改善剤。
- γ−トコフェロールとエクオールとがそれぞれ別個の剤として含まれる、請求項1記載の改善剤。
- γ−トコフェロールとエクオールとが同一の剤として含まれる、請求項1記載の改善剤。
- 前記女性特有の身体的及び/又は精神的不快症状が、痛み、否定的感情、集中力、及び行動の変化からなる群から選択される1つ以上である請求項1〜3のいずれか1項に記載の改善剤。
- 女性特有の身体的及び/又は精神的不快症状が、月経前及び/又は月経中の身体的及び/又は精神的不快症状である、請求項1〜4のいずれか1項に記載の改善剤。
- γートコフェロールとエクオールの配合割合(総量の重量比)が1:0.0001〜1:500である、請求項1〜5のいずれか1項に記載の改善剤。
- γ−トコフェロールの1日摂取量が0.1〜1000mg、及びエクオールの1日摂取量が0.1〜50mgになるように摂取するための、請求項1〜6のいずれか1項に記載の改善剤。
- 請求項1〜7のいずれか1項に記載の改善剤を含む飲食品。
- 飲食品の形態である、請求項1〜7のいずれか1項に記載の改善剤。
- γ−トコフェロールを含む女性特有の身体的及び/又は精神的不快症状の改善剤。
- 前記女性特有の身体的及び/又は精神的不快症状が、痛み、否定的感情、集中力、及び行動の変化からなる群から選択される1つ以上である請求項10に記載の改善剤。
- 前記女性特有の身体的及び/又は精神的不快症状が、月経前及び/又は月経中の身体的及び/又は精神的不快症状である、請求項10又は11に記載の改善剤。
- γ−トコフェロールの1日摂取量が0.1〜1000mgになるように摂取するための、請求項10〜12のいずれか1項に記載の改善剤。
- 請求項10〜13のいずれか1項に記載の改善剤を含む飲食品。
- 飲食品の形態である、請求項10〜13のいずれか1項に記載の改善剤。
- エクオールを含む女性特有の身体的及び/又は精神的不快症状の改善剤。
- 前記女性特有の身体的及び/又は精神的不快症状が、月経前及び/又は月経中の身体的及び/又は精神的不快症状である、請求項16に記載の改善剤。
- 前記女性特有の身体的及び/又は精神的不快症状が、痛み、否定的感情、集中力、及び行動の変化からなる群から選択される1つ以上である、請求項16又は17に記載の改善剤。
- エクオールの1日摂取量が0.1〜50mgになるように摂取するための、請求項16〜18のいずれか1項に記載の改善剤。
- 請求項16〜19のいずれか1項に記載の改善剤を含む飲食品。
- 飲食品の形態である、請求項16〜19のいずれか1項に記載の改善剤。
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