Unique ID issued by UMIN | UMIN000045341 |
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Receipt number | R000051780 |
Scientific Title | Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, crossover trial |
Date of disclosure of the study information | 2021/09/01 |
Last modified on | 2023/03/29 13:04:24 |
Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, crossover trial
Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effect of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The incremental area under the curve (IAUC) of the postprandial blood glucose
1. The maximum blood concentration (Cmax) of the postprandial blood glucose
2. The blood glucose level before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Prevention
Food |
Period I: Pakupakukoubokun
Period II: Placebo
Carbohydrate load: Rice (200 g)
After taking blood samples prior to the ingestion of test foods, take two packs of the test food or placebo with approximately 200 mL of water. Then, take the carbohydrate load within 10 minutes.
*Washout period is for one week and more
Period I: Placebo
Period II: Pakupakukoubokun
Carbohydrate load: Rice (200 g)
After taking blood samples prior to the ingestion of test foods, take two packs of the test food or placebo with approximately 200 mL of water. Then, take the carbohydrate load within 10 minutes.
*Washout period is for one week and more
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects whose Cmax of postprandial blood glucose are between 140 mg/dL and 199 mg/dL at screening (before consumption; Scr)
7. Subjects whose IAUC of postprandial blood glucose are relatively large at Scr
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily
5. Subjects currently taking medicines (include herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, breast-feeding, and planning to become pregnant
8. 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
9. Subjects who are judged as ineligible to participate in the study by the physician
40
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
MAINICHIEGAO. CO., LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2021 | Year | 09 | Month | 01 | Day |
Unpublished
44
Completed
2021 | Year | 08 | Month | 25 | Day |
2021 | Year | 08 | Month | 25 | Day |
2021 | Year | 09 | Month | 03 | Day |
2022 | Year | 02 | Month | 27 | Day |
2021 | Year | 09 | Month | 01 | Day |
2023 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051780
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