試験ID UMIN000045732
最終情報更新日：2022年3月4日
被験食品の摂取が血圧に及ぼす影響
基本情報
| 試験ID | UMIN000045732 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | 被験食品の摂取が血圧に及ぼす影響 | Effects of consumption of the proanthocianidins derived from Acacia Bark on blood pressure: a randomized, double-blind, placebo-controlled, parallel-group trial |
| 平易な研究名称 / Public Title（Acronym） | Effects of consumption of the test food on blood pressure | |
| 試験進捗状況/Recruitment status | 参加者募集終了－試験継続中 | Complete: follow-up continuing |
| 登録日時 | 2021年10月12日 | |
| 最終情報更新日 | 2022年3月4日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | Japan |
|---|---|---|
| 実施都道府県 | ||
| 目標症例数/Target sample size | 40 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 健常者 | Healthy Japanese subjects |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | 期間: 12週間 試験食品: 黒酢濃縮粉末含有食品 用法・用量: 1日1カプセルを水もしくはぬるま湯とともに摂取する ※摂取前検査では初回血圧測定直後に摂取する。 ※1日の用量はその日のうちに摂取する。飲み忘れた場合は気が付いたときに摂取する。 | |
| 介入2 | 期間: 12週間 試験食品: 結晶セルロース含有食品 用法・用量: 1日1カプセルを水もしくはぬるま湯とともに摂取する ※摂取前検査では初回血圧測定直後に摂取する。 ※1日の用量はその日のうちに摂取する。飲み忘れた場合は気が付いたときに摂取する。 | |
| 主要評価項目 / Primary outcomes | 1. 摂取12週間後における座位時収縮期血圧における実測値 | 1. The measured value of sitting systolic blood pressure (SSBP) at 12 weeks after the start of test-food consumption (12w) |
| 副次評価項目 / Secondary outcomes | 1. The measured values of SSBP at four and eight weeks after consumption (4w, 8w) 2. The measured values of sitting diastolic blood pressure (SDBP) at 4w, 8w and 12w 3. The ratio of number of subjects who are SSBP 129 mmHg or less and SDBP 89 mmHg or less at 12w 4. The measured values of SSBP, SDBP and Total Area Under the Curve (tAUC) at before consumption and each subsequent measurement points (30, 60, 90, 120, 150 180 minutes after taking the test food) | |
適格性
| 年齢（下限）/ Age minimum | 20歳以上 | 20years-old |
|---|---|---|
| 年齢（上限）/ Age maximum | Not applicable | |
| 性別 / Gender | 男女両方 | Male and Female |
| 選択基準 / Include criteria | ||
| 除外基準 / Exclude criteria | 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who suffer from coronavirus disease 2019 (COVID-19) 8. Subjects who are smokers 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician |
責任研究者
| 責任研究者 / Name of lead principal investigator | Tsuyoshi Takara | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Medical Corporation Seishinkai, Takara Clinic Director | |
| 住所 / Address | 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan Japan | |
| 電話 / Telephone | 03-5793-3623 | |
| 実施責任組織 / Affiliation | 株式会社オルトメディコ | ORTHOMEDICO Inc. R&D Department |
| 研究費提供組織 / Funding Source | EGAO CO.,LTD. | |
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. Japan 112-0002 | |
|---|---|---|
| 電話 / Telephone | 03-3818-0610 | |
| ホームページURL | ||
| nao@orthomedico.jp | ||
| 担当者 / Name of contact person | Naoko Suzuki |