Unique ID issued by UMIN | UMIN000031596 |
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Receipt number | R000036073 |
Scientific Title | Pilot study of the effect of test drink in subjects with postprandial hyperglycemia. |
Date of disclosure of the study information | 2018/03/05 |
Last modified on | 2018/09/12 19:49:19 |
Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.
Examination of inhibitory effect of test drink on postprandial hyperglycemia.
Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.
Examination of inhibitory effect of test drink on postprandial hyperglycemia.
Japan |
Healthy adult
Adult |
Others
NO
Examination of inhibitory effect of test drink containing plant extract on increase of postprandial blood glucose level.
Efficacy
Postprandial blood glucose level, change of blood glucose level
Area under the curve of blood glucose level, maximum blood glucose level
Interventional
Cross-over
Non-randomized
Open -no one is blinded
Placebo
2
Prevention
Food |
Intake of water (single ingestion) - washout period - beverage containing plant extract (single ingestion)
Intake of beverage containing plant extract (single ingestion) - washout period - water (single ingestion)
20 | years-old | <= |
64 | years-old | >= |
Male and Female
1) Healthy males and females from 20 to 64 years of age
2) Blood glucose level at postprandial 30 minitues is ranged from 130 mg/dL to 199 mg/dL
3) Priority is given to those with a blood glucose peak of 30 minutes
1) Subjects who routinely use health food containing large amount of participating component 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
24
1st name | |
Middle name | |
Last name | Hirona Miura |
Higashi shinjuku Clinic
Director
1-11-3 Okubo Shinjuku-ku Tokyo
03-6233-8581
koike@meiseikai-cl.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.
non-disclosure
Profit organization
NO
2018 | Year | 03 | Month | 05 | Day |
Published
Twenty - four adult men and women with high blood glucose levels 30 minutes after a meal were given a single drink containing a plant extract and water, and the effect of suppressing an increase in postprandial blood glucose level was examined.
As a result, no significant difference was found between the botanical extract-containing beverage and the water in both the primary evaluation item and the secondary evaluation item.
Regarding safety, there were no adverse events in any of the subjects during this study, and there were no problems with safety.
Completed
2018 | Year | 02 | Month | 08 | Day |
2018 | Year | 03 | Month | 06 | Day |
2018 | Year | 03 | Month | 05 | Day |
2018 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036073
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