| 基本情報/Basic information |
| 一般向け試験名/Public title |
植物抽出物含有食品の食後GLP-1上昇作用確認試験
-プラセボ対照ランダム化二重盲検クロスオーバー法-
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A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
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| 一般向け試験名略称/Acronym |
植物抽出物含有食品の食後GLP-1上昇作用確認試験 |
A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1 |
| 科学的試験名/Scientific Title |
植物抽出物含有食品の食後GLP-1上昇作用確認試験
-プラセボ対照ランダム化二重盲検クロスオーバー法-
|
A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
|
| 科学的試験名略称/Scientific Title:Acronym |
植物抽出物含有食品の食後GLP-1上昇作用確認試験 |
A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1 |
| 試験実施地域/Region |
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| 介入/Intervention |
| 群数/No. of arms |
2 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
植物抽出物含有食品、単回摂取⇒ウォッシュアウト⇒植物抽出物非含有食品、単回摂取 |
Food containing plant extract, single ingestion. Wash out. Food not containing plant extract, single ingestion. |
| 介入2/Interventions/Control_2 |
植物抽出物非含有食品、単回摂取⇒ウォッシュアウト⇒植物抽出物含有食品、単回摂取 |
Food not containing plant extract, single ingestion. Wash out. Food containing plant extract, single ingestion. |
| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
①同意取得時の年齢が20歳以上65歳未満の健常男女
②アルコール多量常飲者でない者
③試験責任医師が疾病に罹患していないと判断した者
④試験の目的・内容について十分な説明を受け、同意能力があり、よく理解した上で自発的に参加を志願し、書面で試験参加に同意した者
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(1)Healthy males and females aged 20 to 64 years-old.
(2)Subjects who do not habitually consume a large amounts of alcohol.
(3)Subjects who are judged not suffering from a disease by the investigator.
(4)Subjects who can make self-judgment and are voluntarily giving written informed consent.
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| 除外基準/Key exclusion criteria |
①慢性疾患を有し、医薬品を常用している者
②試験期間中にサプリメント・健康食品（特定保健用食品、機能性表示食品を含む）の摂取をやめることが出来ない者
③スクリーニング検査、有効性確認試験Ⅰ期Ⅱ期2日前からの禁酒が不可能な者
④試験食品及び負荷食の成分に対してアレルギーを有するとの申告があった者
⑤糖尿病、腎・肝疾患・心疾患・呼吸器疾患・内分泌疾患、その他代謝性疾患に罹患している者、治療中の者
⑥消化吸収に影響を与える消化器疾患及び消化器の手術歴がある者
⑦スクリーニング検査で行う検査から、試験責任医師が被験者として不適当と判断した者
⑧スクリーニング検査で貧血症と診断され、頻回採血に適さない者
⑨スクリーニング検査からさかのぼって1週間以内に下痢を発症した者
⑩同意取得日からさかのぼって1ヶ月以内に200 mLまたは3ヶ月以内に400 mLを超える採血、成分献血をした者
⑪薬物依存、アルコール依存の既往歴あるいは現病歴がある者
⑫交代勤務者、深夜勤務者
⑬他の食品の摂取や医薬品を使用する試験、化粧品及び医薬品等を塗布する試験に参加中の者、同意取得1ヶ月以内に他の臨床試験に参加していた者、参加の意思がある者
⑭妊娠している者、試験期間中に妊娠の意思がある者、授乳中の者
⑮その他、試験責任医師が被験者として不適当と判断した者
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(1)Subjects who have a chronic disease and regularly use medications.
(2)Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4)Subjects who have declared allergic reaction to ingredients contained in test foods or loading foods.
(5) Subjects who contract or are under treatment for diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease).
(6)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(7)Subjects who are judged unsuitable for the current study by the screening tests.
(8)Subjects who are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling.
(9) Subjects who have had diarrhea within the last one week prior to the screening tests.
(10)Subjects who have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(11)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(12) Subjects who are shiftworker and/or midnight-shift worker.
(13) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study.
(14) Subjects who are planning to become pregnant after informed consent, pregnant or lactating.
(15) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
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| 目標参加者数/Target sample size |
12 |
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