Unique ID issued by UMIN | UMIN000047664 |
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Receipt number | R000054322 |
Scientific Title | Verification of the effect of test foods on postprandial blood glucose levels (glucose tolerance test) |
Date of disclosure of the study information | 2022/05/06 |
Last modified on | 2022/07/01 18:14:07 |
Verification of the effect of test foods on postprandial blood glucose levels (glucose tolerance test)
Verification of the effect of test foods on postprandial blood glucose levels (glucose tolerance test)
Verification of the effect of test foods on postprandial blood glucose levels (glucose tolerance test)
Verification of the effect of test foods on postprandial blood glucose levels (glucose tolerance test)
Japan |
None
Not applicable | Adult |
Others
NO
To preliminarily confirm the suppression of postprandial blood glucose elevation in healthy adult male subjects by a randomized, double-blind, placebo-controlled, crossover comparative study of the test food intake.
Efficacy
Area under the blood glucose concentration curve AUC (pre-load to 180 min post ingestion)
Blood glucose level (at each blood collection point)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Single intake of test food
Single intake of placebo food
20 | years-old | <= |
60 | years-old | > |
Male
1) Japanese males between the ages of 20 and 60 years old at the time consent is obtained.
2) Persons with no abnormalities in blood glucose levels (no abnormalities in blood glucose levels ever indicated in a medical checkup)
3) BMI between 18.5 kg/m2 and 22.0 kg/m2
4) Persons who have received a full explanation of the purpose and content of the study and who have signed a consent form prior to the start of the study.
1) Those who have a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic diseases.
2) Those who are currently undergoing treatment for a serious illness.
3) Persons with food allergies or those who may develop allergies related to the tested food items.
4) Persons who regularly use medicines or quasi-drugs that may affect the test items.
5) Persons who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items.
6) Those who are unable to discontinue the intake of pharmaceuticals (excluding intravenous medication), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study.
7)Who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent.
8) Those who plan to participate in other clinical trials during the study period.
9)Those whose daily life is extremely irregular.
10)Persons who have difficulty consuming the study food as instructed.
11) Other subjects who are judged by the investigator to be unsuitable for the study.
12
1st name | Masahiko |
Middle name | |
Last name | Nakamura |
Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
department of internal medicine
103-0025
1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
03-6661-9061
mail-1@ouryokukai.sakura.ne.jp
1st name | Masako |
Middle name | |
Last name | Mizuuchi |
APO PLUS STATION CO., LTD.
Clinical Operation Department, CRO Business Division
103-0027
2-14-1 Nihonbashi, Chuo-ku, Tokyo , Japan
03-6386-8809
food-contact@apoplus.co.jp
APO PLUS STATION CO., LTD.
ANGFA Co.,Ltd.
Profit organization
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,Japan
03-6661-9061
c-irb_ug@neues.co.jp
NO
2022 | Year | 05 | Month | 06 | Day |
Unpublished
Completed
2022 | Year | 04 | Month | 26 | Day |
2022 | Year | 04 | Month | 26 | Day |
2022 | Year | 05 | Month | 07 | Day |
2022 | Year | 05 | Month | 16 | Day |
2022 | Year | 05 | Month | 06 | Day |
2022 | Year | 07 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054322
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