Unique ID issued by UMIN | UMIN000035623 |
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Receipt number | R000040545 |
Scientific Title | Suppressive effect of test food on the postprandial blood glucose level. -A randomized, double blind, placebo controlled, cross-over study- |
Date of disclosure of the study information | 2019/02/01 |
Last modified on | 2019/08/06 18:40:00 |
Suppressive effect of test food on the postprandial blood glucose level. -A randomized, double blind, placebo controlled, cross-over study-
Suppressive effect of test food on the postprandial blood glucose level.
Suppressive effect of test food on the postprandial blood glucose level. -A randomized, double blind, placebo controlled, cross-over study-
Suppressive effect of test food on the postprandial blood glucose level.
Japan |
Adult men and women
Adult |
Others
NO
To investigate the effect of test food on the postprandial blood glucose level of subjects.
Efficacy
Confirmatory
Not applicable
Area under the curve for postprandial blood glucose level.
Area under the curve for postprandial blood glucose levels, and insulin levels and postprandial blood glucose levels at 30, 60, 90, and 120 minutes after rice ingestion.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
NO
No need to know
2
Treatment
Food |
Intake of test food (single ingestion) - washout period - intake of placebo (single ingestion)
Intake of placebo (single ingestion) - washout period - intake of test food (single ingestion)
20 | years-old | <= |
65 | years-old | > |
Male and Female
1)Males and females from 20 to 64 years of age.
2)Subjects whose fasting blood glucose levels is 125 mg/dL or less.
3)Subjects whose postprandial blood glucose levels at 30 or 60 minutes after 200g rice ingestion is 140 mg/dL or less.
4)Subjects whose postprandial blood glucose levels at 120 minutes after 200g rice ingestion is 199 mg/dL or less.
1)Subjects who have serious medical history or who had digestive tract resectional surgery (except for appendectomy).
2)Subjects whose HbA1c(NGSP) is 6.5% or more.
3)Subjects who routinely use medicine, supplements, FOSHU, and/or health food which may affect the result of the study.
4)Subjects who have allergy to the test food or rice.
5)Subjects who are planning to become pregnant during informed consent for the current study or are pregnant or lactating.
6)Heavy use of alcohol or heavy smokers.
7)Subjects who are judged as inappropriate to participate in the study by the investigator for other reasons.
40
1st name | Kazuhiko |
Middle name | |
Last name | Takano |
Medical Corporation Hokubukai Utsukushigaoka Hospital
Clinical Pharmacology Center
004-0839
61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
001-882-0111
takano@ughp-cpc.jp
1st name | Isao |
Middle name | |
Last name | Takehara |
Clinical Support Corporation Limited
Food Service Division
060-0061
4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
011-223-3130
takehara@csc-smo.co.jp
FANCL Corporation
FANCL Corporation
Profit organization
Japan
Medical corporation Hokubukai beauty hill hospital ethics review committee
No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido
011-882-0111
wakimoto@ughp-cpc.jp
NO
医療法人北武会美しが丘病院(北海道)
2019 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 12 | Month | 13 | Day |
2019 | Year | 01 | Month | 10 | Day |
2019 | Year | 02 | Month | 13 | Day |
2019 | Year | 02 | Month | 21 | Day |
2019 | Year | 01 | Month | 22 | Day |
2019 | Year | 08 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040545
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