Unique ID issued by UMIN | UMIN000043836 |
---|---|
Receipt number | R000050029 |
Scientific Title | Influence on physical condition by "healthy meal" intake on males with high blood glucose |
Date of disclosure of the study information | 2021/04/04 |
Last modified on | 2021/09/08 11:57:06 |
Influence on physical condition by "healthy meal" intake on males with high blood glucose
Influence on physical condition by "healthy meal" intake on males with high blood glucose
Influence on physical condition by "healthy meal" intake on males with high blood glucose
Influence on physical condition by "healthy meal" intake on males with high blood glucose
Japan |
Not applicable
Not applicable | Adult |
Others
NO
To evaluate the change on physical condition by "healthy meal" intake
Efficacy
HbA1c, fasting blood glucose at 4 week test
Blood glucose / insulin level after 75 g OGTT, each change amount, area under the concentration time curve (blood glucose / insulin AUC), blood glucose peak value (blood glucose / insulin Cmax), insulin, HOMA-IR, adiponectin, insulin, HOMA-beta at 4 week test
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Prevention
Food |
Intake "healthy meal" for 20 days
Eat usual meal
30 | years-old | <= |
64 | years-old | >= |
Male
1) Males aged between 30 and 64
2) Subjects who equal to or more than 5.6 % of HbA1c
3) Among the subjects who met the inclusion criteria 1) and 2), select from the subjects with high fasting blood glucose
1) Subjects who are unable to continuously intake "healthy meal" during intake period
2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and the results of preliminary examination
3) Subjects who are judged as unsuitable for the study based on the medical history
4) Subjects with food allergies
5) Subjects who have difficulty in treatment by participating in the study
6) Subjects who are receiving treatment or use equipment that affects the examination
7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
8) Subjects who have participated in other clinical study prior to the current study
9) Subjects who routinely take health foods that may affect the results
10) Subjects who regularly consume large amount of alcohol
11) Subjects who smoke excessively (more than 21 cigarettes a day)
12) Subjects with extremely irregular diet
13) Subjects with irregular life rhythms
14) Subjects who undergoes a medical examination from 2 weeks before the preliminary examination and the end of the study
15) Subjects who plan to donate blood during the study period
16) Subjects who judged as unsuitable for the study by the investigator for other reasons
100
1st name | Tsuyoshi |
Middle name | |
Last name | Yamato |
Medical Corporation Kouwakai Kouwa Clinic
Internal medicine, Director
170-0003
6-33-17, Komagome, Toyoshima-ku, Tokyo
03-3917-8105
info@kouwakai.jp
1st name | Takashi |
Middle name | |
Last name | Nakagawa |
EP Mediate Co., Ltd.
Development Business Headquarters, TTC Center, Trial Planning Department
162-0822
Turuya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
03-5657-4983
nakagawa768@eps.co.jp
EP Mediate Co., Ltd.
non-disclosure
Profit organization
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguro-ku, Tokyo
03-6452-2712
saito876@eps.co.jp
NO
2021 | Year | 04 | Month | 04 | Day |
Unpublished
Completed
2021 | Year | 03 | Month | 25 | Day |
2021 | Year | 03 | Month | 25 | Day |
2021 | Year | 04 | Month | 05 | Day |
2021 | Year | 07 | Month | 17 | Day |
2021 | Year | 04 | Month | 04 | Day |
2021 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050029
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |