Unique ID issued by UMIN | UMIN000017447 |
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Receipt number | R000020082 |
Scientific Title | Effects of grain constituent on postprandial hyperglycemia : placebo-controlled double blind cross-over trial |
Date of disclosure of the study information | 2015/05/16 |
Last modified on | 2019/08/22 11:30:15 |
Effects of grain constituent on postprandial hyperglycemia
: placebo-controlled double blind cross-over trial
Effects of grain constituent on postprandial hyperglycemia
Effects of grain constituent on postprandial hyperglycemia
: placebo-controlled double blind cross-over trial
Effects of grain constituent on postprandial hyperglycemia
Japan |
Healthy adult
Endocrinology and Metabolism | Adult |
Others
NO
To investigate the effect of a food product on postprandial hyperglycemia
Efficacy
Blood samples were collected before ingestion and 0.5,1,2,3,4 and 5 hours after ingestion.Urine samples were collected before ingestion and accumulation urine samples were pooled during the postprandial reriods for 5 hrs. Primary outcome is postprandial blood glucose
Key secondary outcomes are insulin, triglyceride and glucose-dependent insulinotropic polypeptide.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
The subjects ingested a single intake of the active meal, and ingested a single intake of the placebo meal after 7 days.
The subjects ingested a single intake of the placebo meal, and ingested a single intake of the active meal after 7 days.
30 | years-old | <= |
60 | years-old | > |
Male
1) Twenty subjects are divided into two groups at each ten subjects as described bilow.
10 subjects whose fasting blood glucose levels are ranged from 110 mg/dl to less than 125 mg/dl .10 subject whose fasting blood glucose levels are ranged to less than 110 mg/dl.
2) Subjects whose BMI are from 20 kg/m2 to less than 28 kg/m2.
3) Subjects whose systolic blood pressure is 139 mmHg or less and diastolic blood pressure is 89 mmHg or less.
4) Subjects whose triglyceride is 50 mg/dl or more and 149 mg/dl or less.
5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
1) Subjects who take continuous medical treatment.
2) Subjects who are contracting heart disease, liver disease, kidney disease, digestive disease and allergy disease.
3) Subjects with serious infection
4) Subjects with smoking habit
5) Those whose amount of drinking on the 1st is more than 500 ml in beer conversion.
6) Subjects who are doing carbohydrates restricted diet now.
7) Subjects who participate in other clinical trials.
8) Subjects who are not eligible due to physician's judgment.
20
1st name | Chiaki |
Middle name | |
Last name | Shibakiri |
QOL RD Co.,Ltd.
CRO Department Food Division
1030027
Front Place Nihonbashi Bldg.,2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027,Japan
03-6386-8809
c-shibakiri@qol-rd.co.jp
1st name | Higashino |
Middle name | |
Last name | Nobuyuki |
QOL RD Co.,Ltd.
CRO Department Food Division
1030027
Front Place Nihonbashi Bldg.,2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027,Japan
03-6386-8809
n-higashino@qol-rd.co.jp
QOL RD Co.,Ltd.
Kao Corporation
Profit organization
Japan
Human Research Ethics Committee of Biological Science Laboratories of Kao Corporation
2606, Akabane,Ichikai-Machi,Haga-Gun,Tochigi 321-3497,Japan
0285-68-7589
taguchi.hiroyuki@kao.co.jp
NO
医療法人社団冠心会大崎病院東京ハートセンター(東京都)
2015 | Year | 05 | Month | 16 | Day |
Unpublished due to the protocol including the intellectual property rights
Published
http://pubs.sciepub.com/jfnr/5/5/1/
23
Main results already published
2015 | Year | 03 | Month | 18 | Day |
2015 | Year | 02 | Month | 18 | Day |
2015 | Year | 05 | Month | 16 | Day |
2018 | Year | 08 | Month | 23 | Day |
2015 | Year | 05 | Month | 07 | Day |
2019 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020082
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