1. 【研究の目的】消費者科学と規制科学の両側面から保健機能食品制度と社会の調和のための判断基準を提案し, 保健機能性食品の活用や開発促進に繋げることが本研究の目的である。
2. 【研究の内容】3か年計画の1年目であるため, 2017度は3つの大きな枠組みのうち【規制・制度に関する研究】機能性評価に必要な臨床試験の在り方に関して5つの側面から研究を遂行した。
3. 【成果】本研究の遂行により保健機能食品の有効性評価に必要な臨床試験における科学的根拠の考え方に関する新たな提言のために必要な根拠となる研究成果を得ることができた。 本研究の成果は, 国際誌(Journal of Functional Foods, Trends in Food Science & Technology, 及びInternational Journal of Nutritional Sciences)へ3報, 掲載又は受理され, 国内誌(日本補完代替医療学会誌)へ1報, 掲載された。また, 本研究に関して, 第15回日本機能性食品医用学会総会/教育講演(招待)を行い, 第39回日本臨床栄養学会総会・第38回日本臨床栄養協会総会及び第76回日本公衆衛生学会総会にて口頭発表を行った。現在, Journal of Functional Foodsへ2報(原著論文)投稿準備中である。
4. 【2017年度 : 研究成果】
1)我が国における保健機能食品制度の歴史を分析した上で, 当該領域における規制科学及び消費者科学の必要性を明確化した。2)保健機能食品と医薬品それぞれの臨床試験における有効性及び安全性に関する評価系等を比較し, 保健機能食品の臨床試験に関するガイドラインが要求する事項の特徴やその潜在的な課題を明らかにした。3)機能性表示食品制度における有効性に関する科学的根拠の質を確保するために, 有効性の根拠資料に用いられるランダム化比較試験の報告の質の検討を行った結果, CONSORT声明チェックリスト全29項目に対する平均記載割合は47.6%, 中央値13(最小6, 最大25)であった。項目別には, 「目標症例数」, 「割付」, 「結果と介入のエフェクトサイズや精度」, 「一般化可能性」の項目が質の向上のために報告改善が必要な項目として特定された。4)特定保健用食品における審査の長期化が商品の価値の劣化を招き, 企業販売戦略の支障となることから機能性表示食品に比べて企業に負担感があることから, 審査における論点を事前に見える化することで, これらの解消に向けた検討を行った。 5)世界的に市場規模が大きい食後血糖値降下及び整腸系に関する保健の用途を持つ機能性関与成分の機能性評価に必要な科学的根拠に対する考え方, 及び現行の臨床評価ガイドラインの内容充実のために国内外で検討が必要な項目を特定し, 国内外の審査事例や各種文献を通して考察した。
【総括】これら評価系等の違いを考慮した上で, 国際調和を加味した臨床評価ガイドラインの検討を重ねることで, 保健機能食品の適切な評価, 評価の透明性の確保, 審査や開発のしやすさに繋がると考える。
The regulatory system for foods with health claims (FHC) has been investigated. Regulatory science researches have been done as shown below. These results from this project are very important for further international harmonization in the world.
1) I proposed the need for consumer science and regulatory science research through reviewing the history and recent topics about the regulation on FHC in Japan.These results were published as a research paper entitled "The need for consumer science and regulatory science research on functional foods with health claims What should we do to harmonize science and technology with society?".
2) I clarified the differences on regulations between FHC and ethical pharmaceuticals regarding their safety and efficacy in clinical trials, which are required to provide them with scientific evidence. These results were published as a research paper entitled "Differences on the Regulation between Foods with Health Claims and Ethical Pharmaceuticals from the Viewpoint of Regulatory Science".
3) A new system for foods with functional claims (FFC) was implemented in April 2015. The efficacy of FFC must now be proven by systematic review or randomized clinical trials (RCTs). The aim of this study was to establish the scientific reporting quality of RCTs on the efficacy of FFC and to identify areas that require improvement. The reporting quality of 33 RCT papers on 31 FFC that were received between April 1, 2015 and December 31, 2016 were analyzed by two experts with regard to consistency with the 29 Consolidated Standards of Reporting Trials (CONSORT) items. RCTs on FFC reported 13.8 (47.6%) of the CONSORT items, which is similar to those on FOSHU. There were 7 least reported items, including study design. Determining the reporting quality of FFC studies is an important way of identifying items that require improvement in future papers. These results were published as a research paper entitled "Evaluation of randomized controlled trials of foods with functional claims request: the learning outcomes from studies in Japan".
4) Identifying frequent and important discussion topics in FOSHU review meetings will therefore facilitate communication and promote effective discussion between regulators and food business operators, enhancing the Foods with Heath Claims (FHC) process. To identify discussion topics raised in meetings for approval review of FOSHU in Japan to improve the FHC process. The 31 meeting minutes raised 253 discussion topics under four major categories: food labeling (50.6%), efficacy and safety (25.7%), other (15.4%) and product (8.3%). Food labeling of FOSHU was identified as an important discussion point. Correct labelling can help ensure that consumers understand and select the most suitable products for their health needs. These results were published as a research paper entitled "Clarifying discussion topics in regulatory reviews of foods with health claims in Japan for food business operators and regulators around the world".
5) Harmonized guidelines on health claims may reduce future global trade barriers. We then aimed to re-evaluate articles cited in systematic reviews used as evidence in applications for the health claim "reduction of post-prandial glycemic responses" for hydrolyzed guar gum and indigestible dextrin, according to our new criteria. Our major findings were that 64% and 48% of articles failed to assess insulin level as a secondary outcome and conduct nutrient profiling of the test food, respectively. Our findings suggest the need for updated guidelines based on scientific evidence for efficacy evaluation for health claims in both countries.