Unique ID issued by UMIN | UMIN000023496 |
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Receipt number | R000027065 |
Scientific Title | A study for evaluating the effect of the intake of food containing HYA on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial |
Date of disclosure of the study information | 2016/08/04 |
Last modified on | 2017/04/12 18:36:13 |
A study for evaluating the effect of the intake of food containing HYA on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial
A study for evaluating the effect of the intake of food containing HYA
A study for evaluating the effect of the intake of food containing HYA on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial
A study for evaluating the effect of the intake of food containing HYA
Japan |
Healthy adult
Adult |
Others
NO
To investigate the dose-finding of effect of food containing HYA on postprandial hyperglycemia
Efficacy
Area under the curve of plasma glucose levels
Postprandial blood glucose, maximum plasma glucose levels, postprandial insulin levels
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Intake of food without HYA (single ingestion) - washout period - food containing low-dose HYA (single ingestion) - washout period - food containing high-dose HYA (single ingestion)
Intake of food containing low-dose HYA (single ingestion) - washout period - food containing high-dose HYA (single ingestion) - washout period - food without HYA (single ingestion)
Intake of food containing high -dose HYA (single ingestion) - washout period - food without HYA (single ingestion) - washout period - food containing low-dose HYA (single ingestion)
20 | years-old | <= |
69 | years-old | >= |
Male and Female
1) Males and females from 20 to 69 years of age
2) postprandial blood glucose levels are ranged from 140 mg/dL to 199 mg/dL
1) Subjects who routinely use health food containing large amount of fatty acids or health food for diet
2) Subjects routinely taking medicine or health food which may influence glucose metabolism
3) Subjects who have body mass index (BMI) less than 18.5 kg/square meter or more than 30.0 kg/square meter
4) Subjects who have fasting blood glucose more than 126 mg/dL on preliminary examination
5) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
6) Subjects having possibilities for emerging allergy related to the current study
7) Subjects who are under medication or having a history of serious diseases for which medication was required
8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
10) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
12) Subjects judged as unsuitable for the study by the investigator for other reasons
60
1st name | |
Middle name | |
Last name | Yasunori Yonejima |
NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.
Research and Development Division
35-3, Minamibiraki., Kamiueno-cho, Muko-shi Kyoto
075-921-5344
y.yonejima@nitto-ph.com
1st name | |
Middle name | |
Last name | Shinsuke Tsuji |
TTC Co., Ltd.
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
s.tsuji@ttc-tokyo.co.jp
TTC Co., Ltd
NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.
Self funding
NO
2016 | Year | 08 | Month | 04 | Day |
Published
Compared with the placebo, low- and high-dose HYA showed a significant suppress the AUC of plasma glucose levels, maximum plasma glucose levels and postprandial blood glucose.
Completed
2016 | Year | 07 | Month | 13 | Day |
2016 | Year | 08 | Month | 05 | Day |
2016 | Year | 08 | Month | 04 | Day |
2017 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027065
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