Unique ID issued by UMIN | UMIN000033160 |
---|---|
Receipt number | R000037817 |
Scientific Title | A study for safety evaluation of excess consumption of the test drink. |
Date of disclosure of the study information | 2019/06/27 |
Last modified on | 2020/10/09 11:32:39 |
A study for safety evaluation of excess consumption of the test drink.
Safety evaluation of excess consumption of the test drink.
A study for safety evaluation of excess consumption of the test drink.
Safety evaluation of excess consumption of the test drink.
Japan |
Healthy adult
Adult |
Others
NO
Safety evaluation of 3 times consumption of daily dose of the test drink, which contain indigestible dextrin in 4 consecutive weeks.
Safety
Presence or absence of, kind of, severity of, frequency of, side effects and adverse events, involved abnormal variations of the clinical test data.
Presence or absence of abnormal variations in clinical tests data.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
The drink which contains indigestible dextrin. Intake four weeks.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1)Males and females aged 20 to 64years old. Contain around four subjects whose fasting neutral fat level is 120mg/dL to 199mg/dL.
(2) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
(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 constitution of weak stomach and of tendency of diarrhea.
(4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(5)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
(6)Subjects who excessive alcohol intake.
(7)Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(8)Subjects who have previous medical history of drug and/or food allergy.
(9) 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.
(10)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(11) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(12) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(13) 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.
(14) 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.
(15)Others who have been determined ineligible by principal investigator or sub-investigator.
16
1st name | Suguru |
Middle name | |
Last name | Fujiwara |
CPCC Company Limited
Clinical Research Planning Department
101-0047
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-3112
info@cpcc.co.jp
1st name | Masanori |
Middle name | |
Last name | Numa |
CPCC Company Limited
Planning & Sales Department
101-0047
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-3112
info@cpcc.co.jp
CPCC Company Limited
FV Japan Co.,Ltd.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-5548
IRB@cpcc.co.jp
NO
2019 | Year | 06 | Month | 27 | Day |
Unpublished
Completed
2018 | Year | 06 | Month | 21 | Day |
2018 | Year | 06 | Month | 28 | Day |
2018 | Year | 06 | Month | 27 | Day |
2020 | Year | 10 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037817