Unique ID issued by UMIN | UMIN000017949 |
---|---|
Receipt number | R000020801 |
Scientific Title | Safety evaluation of excessive consumption of indigestible dextrin beverage in men and women. |
Date of disclosure of the study information | 2015/06/22 |
Last modified on | 2016/02/18 19:52:07 |
Safety evaluation of excessive consumption of indigestible dextrin beverage in men and women.
Safety evaluation of excessive consumption of indigestible dextrin beverage in men and women.
Safety evaluation of excessive consumption of indigestible dextrin beverage in men and women.
Safety evaluation of excessive consumption of indigestible dextrin beverage in men and women.
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of excessive consumption of indigestible dextrin beverage, 3-fold quantity of recommended daily intake.
Safety
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/ body mass index
Doctor's questions
Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
test beverage containing of indigestible dextrin
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. triglyceride levels are ranged from 120 mg/dL to 199 mg/dL (10 or more subjects)
B. blood glucose levels are ranged from 110 mg/dL to 125 mg/dL (10 or more subjects)
C. triglyceride levels are less than 120 mg/dL and blood glucose levels are less than 110 mg/dL (10 or more subjects)
(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
33
1st name | |
Middle name | |
Last name | Norimasa Sato |
Umeda Oak Clinic
Internal Medicine
2-6-6, Sonezaki, Kita-ku, Osaka-City, Osaka
06-6130-8735
info-umeda@ouryokukai.jp
1st name | |
Middle name | |
Last name | Kazumi Tagami |
TTC Co.,Ltd
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
k.tagami@ttc-tokyo.co.jp
TTC Co., Ltd.
Coca Cola japan Co. Ltd.
Profit organization
NO
2015 | Year | 06 | Month | 22 | Day |
Unpublished
Completed
2015 | Year | 05 | Month | 28 | Day |
2015 | Year | 06 | Month | 22 | Day |
2015 | Year | 06 | Month | 17 | Day |
2016 | Year | 02 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020801
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |