Unique ID issued by UMIN | UMIN000053899 |
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Receipt number | R000061527 |
Scientific Title | A verification study of the suppressive effect on the elevation of blood glucose level: a randomized, placebo-controlled, open-label, crossover comparison study |
Date of disclosure of the study information | 2024/03/19 |
Last modified on | 2024/03/19 13:27:52 |
A verification study of the suppressive effect on the elevation of blood glucose level: a randomized, placebo-controlled, open-label, crossover comparison study
A verification study of the suppressive effect on the elevation of blood glucose level: a randomized, placebo-controlled, open-label, crossover comparison study
A verification study of the suppressive effect on the elevation of blood glucose level: a randomized, placebo-controlled, open-label, crossover comparison study
A verification study of the suppressive effect on the elevation of blood glucose level
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the effect of the test food consumption on the elevation of postprandial blood glucose in healthy Japanese.
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The maximum blood concentration (Cmax) of the glucose
2. The incremental area under the curve (IAUC) of the blood glucose
1. The total AUC (TAUC), delta Cmax (difference from before carbohydrate load to Cmax), and the time to maximum blood concentration (Tmax) of the blood glucose
2. IAUC and Cmax of the blood insulin levels
3. The measured values of the blood glucose and insulin levels at 0, 30, 60, 90, and 120 minutes after consumption of the carbohydrate load, and the amount of changes of each item from 0 minutes after consumption of the carbohydrate load
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Placebo
Institution is not considered as adjustment factor.
YES
2
Prevention
Food |
Duration: Once
Test food:
< Test 1> Tea beverage
< Test 2> Placebo beverage
*The intervention sequence is Test 1 to Test 2.
*Washout period is for one week and more.
Duration: Once
Test food:
<Test 1> Placebo beverage
< Test 2> Tea beverage
*The intervention sequence is Test 1 to Test 2.
*Washout period is for one week and more.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
1. Japanese
2. Men or women
3. Individuals aged between 20 and 64
4. Healthy individuals
5. Individuals whose fasting blood glucose level is >=70 and <126 mg/dL, whose blood glucose level at 120 minutes after consumption of a carbohydrate load (Trelan-G 75 g) is <200 mg/dL, and whose Cmax of the glucose after consumption of a carbohydrate load (Trelan-G 75 g) is <=140 mg/dL at screening (before consumption; Scr)
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines and/or foods related to the test product, particularly who show allergic reactions to green tea, rice, and/or agar
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
9. Individuals who are judged as ineligible to participate in this study by the physician
10
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.
ITO EN, 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 Bldg., 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)
2024 | Year | 03 | Month | 19 | Day |
Unpublished
Open public recruiting
2024 | Year | 03 | Month | 13 | Day |
2024 | Year | 03 | Month | 13 | Day |
2024 | Year | 03 | Month | 19 | Day |
2024 | Year | 06 | Month | 04 | Day |
2024 | Year | 03 | Month | 19 | Day |
2024 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061527
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