Unique ID issued by UMIN | UMIN000018447 |
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Receipt number | R000021360 |
Scientific Title | A study for safety evaluation of excess consumption of the drink containing indigestible dextrin. |
Date of disclosure of the study information | 2015/07/30 |
Last modified on | 2015/12/24 08:10:25 |
A study for safety evaluation of excess consumption of the drink containing indigestible dextrin.
A study for safety evaluation of excess consumption of the drink containing indigestible dextrin.
A study for safety evaluation of excess consumption of the drink containing indigestible dextrin.
A study for safety evaluation of excess consumption of the drink containing indigestible dextrin.
Japan |
Healthy adult
Not applicable | Adult |
Others
NO
To evaluate the safety of excessive consumption of indigestible dextrin for 4 weeks
Safety
The incidence of side effects
Blood test
Urine test
Blood pressure/pulsation
Weight/body mass index
Medical interview
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Drink which is contain indigestible dextrin 5g as dietary fiber. Intake 1050mL/day, 4 weeks.
Drink which is not contain indigestible dextrin. Intake 1050mL/day, 4 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1)Subjects giving written informed consent.
(2)Healthy males and females aged 20 to 64 years old.
(3) Subjects who falls under any of the following criteria.
A. Fasting blood glucose levels at preliminary test are less than 100mg/dL. (around 18 subjects)
B. Fasting blood glucose levels at preliminary test are between more than 100mg/dL and less than 126mg/dL. (around 12 subjects)
(1)Subjects who are given continuous treatment by taking medicines.
(2) Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results.
(3)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
(4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(5)Subjects who excessive alcohol intake.
(6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(7)Subjects who have previous medical history of drug and/or food allergy.
(8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(9)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(10) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(11) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(13) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(14)Others who have been determined ineligible by principal investigator or sub-investigator.
30
1st name | |
Middle name | |
Last name | Katsuhisa Sakano |
CPCC Company Limited
Clinical Research Planning Department
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
03-5297-3112
k.s@cpcc.co.jp
1st name | |
Middle name | |
Last name | Makoto Ichinohe |
CPCC Company Limited
Plan Sales Department
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
03-5297-3112
m.i@cpcc.co.jp
CPCC Company Limited
ASAHI BREWERIES,LTD.
Profit organization
NO
2015 | Year | 07 | Month | 30 | Day |
Unpublished
Completed
2015 | Year | 07 | Month | 21 | Day |
2015 | Year | 08 | Month | 20 | Day |
2015 | Year | 07 | Month | 28 | Day |
2015 | Year | 12 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021360
Research Plan | |
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Research case data | |
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