Unique ID issued by UMIN | UMIN000036086 |
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Receipt number | R000041037 |
Scientific Title | Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food. |
Date of disclosure of the study information | 2020/03/22 |
Last modified on | 2019/09/18 13:50:59 |
Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Japan |
Not applicable
Adult |
Others
NO
To evaluate the effect of suppression of increase in blood glucose level by ingestion of wheat albumin or wheat albumin and carrageen.
Safety,Efficacy
<Efficacy>
Area under the curve of blood glucose level from time zero to the 120 minutes.
Blood glucose level at the time of blood sampling.
<Efficacy>
Cmax of blood glucose level
Tmax of blood glucose level
Area under the curve of blood insulin level from time zero to the 120 minutes
Cmax of blood insulin level
Tmax of blood insulin level
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Treatment
Food |
Single intake of Capsules containing wheat albumin
Single intake of Capsules containing wheat albumin and carrageen
Single intake of Capsules containing cellulose
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Males and females equal to or more than 20 years and less than 65 years old
2. In the 75g oral glucose tolerance test, subjects with a fasting blood glucose level of 110 mg / dL or more and less than 126 mg / dL or a 2 hour value of 140 mg / dL or more and less than 200 mg / dL.
3. Possible study volunteer to visit
4. Subjects who recognize the object and contents of the study and submit the written informed consent
1. Subjects who develop diabetes (Recommended by Japan Diabetes Society).
2. Subjects who have a history of large surgery (gastrectomy,gastrointestinal suture, intestinal resection) on the gastrointestinal except who resect the cecum.
3. Subjects who have marked impairment of heart, liver, kidney, thyroid, and other diseases.
4. Subjects who experienced unpleasant feeling by drawing blood in the past.
5. Subjects who have difficulty drawing blood from the peripheral vein.
6. Subjects who donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study.
7. Subjects who are allergic to the test food or who have serious drugs or food allergies.
8. Shift worker and night worker.
9. Subjects whose eating habits are extremely irregular.
10. Heavy drinkers(Average of the amount of pure alcohol per day 40 g or more).
11. Heavy Smokers(More than 21 on average per day)
12. Subjects who are positive for one or more items in the results of virus / immunologic serology examination at the time of prior to the study
13. Pregnant women or breast-feeding women.
14. Subjects who regularly use medicines, health foods, etc. that may affect the study
15. Sujects who was judged ineligibles by clinician in this trial.
12
1st name | Shinpei |
Middle name | |
Last name | Tomita |
New drug research center, Inc.
General Manager Clinical Research Dept.
061-1405
452-1Toiso,Eniwa-shi,Hokkaido, Japan
0123-34-0412
s-tomita@ndrcenter.co.jp
1st name | Yoshitaka |
Middle name | |
Last name | Hatakeyama |
New Drug Research Center, Inc.
Clinical Research Dept.
061-1405
452-1Toiso,Eniwa-shi,Hokkaido, Japan
0123-34-0412
y-hatakeyama@ndrcenter.co.jp
Nissin Pharma Inc.
Nissin Pharma Inc.
Profit organization
Miyawaki Orthopedic Clinic Industrial Review Board
3-1-6 Ariaketyou,Eniwa-shi,Hokkaido, Japan
0123-33-4026
d-kameda@mediffom.co.jp
NO
2020 | Year | 03 | Month | 22 | Day |
Unpublished
12
Completed
2019 | Year | 02 | Month | 05 | Day |
2019 | Year | 02 | Month | 05 | Day |
2019 | Year | 03 | Month | 06 | Day |
2019 | Year | 03 | Month | 23 | Day |
2019 | Year | 03 | Month | 05 | Day |
2019 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041037
Research Plan | |
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Research case data specifications | |
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Research case data | |
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