Unique ID issued by UMIN | UMIN000021234 |
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Receipt number | R000024496 |
Scientific Title | Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women |
Date of disclosure of the study information | 2016/02/27 |
Last modified on | 2017/08/29 09:11:04 |
Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women
Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women
Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women
Safety evaluation of 12 weeks consumption of indigestible dextrin carbonated beverage in men and women
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of ingestion of indigestible dextrin carbonated beverage for 12 consecutive week.
Safety
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/ body mass index
Doctor's questions
Adverse event
Evaluate at points of 4-week, 8-week and 12-week consumption and 4 weeks after the end of consumption period.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Intake of an indigestible dextrin-containing carbonated beverage 1 bottle per day for 12 weeks.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
1) Males and females from 20 to 64 years of age
2) Subjects falling under any of the following
A. fasting blood glucose levels are ranged 110 to 125 mg/dL
B. 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL
1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease
2) Subjects having possibilities for emerging allergy related to the study
3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
5) 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
6) Subjects who intend to become pregnant or lactating
7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
8) Subjects judged as unsuitable for the study by the investigator for other reasons
10
1st name | |
Middle name | |
Last name | Yasuyuki Kowatari |
Aisei Hospital Ueno Clinic
Internal Medicine
2-18-6 higashiueno, taito-ku, Tokyo, Japan
03-3834-3518
cl-rece@aisei-byouin.or.jp
1st name | |
Middle name | |
Last name | Mika Watanabe |
TTC Co.,Ltd.
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
m.watanabe@ttc-tokyo.co.jp
TTC Co., Ltd.
Coca Cola japan Co. Ltd.
Profit organization
NO
2016 | Year | 02 | Month | 27 | Day |
Unpublished
Completed
2016 | Year | 02 | Month | 04 | Day |
2016 | Year | 02 | Month | 28 | Day |
2016 | Year | 02 | Month | 27 | Day |
2017 | Year | 08 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024496
Research Plan | |
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