Unique ID issued by UMIN | UMIN000031272 |
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Receipt number | R000035706 |
Scientific Title | Safety evaluation study of excessive consumption of dietary fiber in carbonated water |
Date of disclosure of the study information | 2018/12/28 |
Last modified on | 2019/08/23 11:54:55 |
Safety evaluation study of excessive consumption of dietary fiber in carbonated water
Safety evaluation study of excessive consumption of dietary fiber in carbonated water
Safety evaluation study of excessive consumption of dietary fiber in carbonated water
Safety evaluation study of excessive consumption of dietary fiber in carbonated water
Japan |
Not applicable
Adult |
Others
NO
To evaluate the safety of excessive consumption of 3-fold dietary fiber of the recommended daily intake in carbonated water.
Safety
Safety evaluation items: Examination by a physician in charge, Physical examination findings, Clinical laboratory findings (Hematological test, Biochemical test, Urine analysis), Subjective symptoms
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Ingestion of 3-fold dietary fiber of the recommended daily intake in test food for 4 weeks.
20 | years-old | <= |
70 | years-old | > |
Male and Female
(1)Japanese adult male and female from 20 to 69 years old at the time of acquiring consent.
(2)Healthy subjects whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening, or subjects with triglyceride values from 150 - 199 mg/dL whose physical examination findings and clinical laboratory findings other than triglyceride value do not deviate greatly from the normal values at the time of screening.
(3)Subjects who are available at every designated hospital visit.
(4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
(1)Subjects with history of serious diseases or subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases.
(2)Subjects with a surgical history of digestive system (except appendicectomy).
(3)Subjects with chronic diseases under treatment.
(4)Subjects who are pregnant or lactating, or intend to become pregnant during the study.
(5)Subjects who consume excessive alcohol (equivalent to more than 540 mL/day of sake or 1,500 mL/day of 5% beer or such) for 5 days or more per week.
(6)Subjects who are aware of having weak stomach or difficulties of taking blended tea beverages.
(7)Subjects judged as unsuitable for the study by principal investigator with other reasons.
16
1st name | Kazuhiko |
Middle name | |
Last name | Takano |
Medical Corporation Hokubukai Utsukushigaoka Hospital
Clinical Pharmacology Center
004-0839
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
011-882-0111
wakimoto@ughp-cpc.jp
1st name | Ryota |
Middle name | |
Last name | Wakimoto |
Medical Corporation Hokubukai Utsukushigaoka Hospital
Clinical Pharmacology Center
004-0839
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
011-882-0111
wakimoto@ughp-cpc.jp
Medical Corporation Hokubukai Utsukushigaoka Hospital
Fukuren Co., Ltd.
Profit organization
Japan
Medical Corporation Hokubukai Utsukushigaoka Hospital IRB
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
011-881-0111
wakimoto@ughp-cpc.jp
NO
医療法人北武会 美しが丘病院
2018 | Year | 12 | Month | 28 | Day |
Safety evaluation study of excessive consumption of dietary fiber in carbonated water
Unpublished
Safety was confirmed.
16
Safety was confirmed.
2019 | Year | 08 | Month | 23 | Day |
(1) Japanese adult male and female from 20 to 69 years old at the time of acquiring consent.
(2) Healthy subjects whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening, or subjects with triglyceride values from 150 - 199 mg/dL whose physical examination findings and clinical laboratory findings other than triglyceride value do not deviate greatly from the normal values at the time of screening.
(3) Subjects who are available at every designated hospital visit.
(4) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
screening
Selection
intake
Inspection
None
safety
Completed
2017 | Year | 12 | Month | 07 | Day |
2017 | Year | 12 | Month | 14 | Day |
2018 | Year | 02 | Month | 14 | Day |
2018 | Year | 03 | Month | 14 | Day |
2018 | Year | 07 | Month | 31 | Day |
2018 | Year | 02 | Month | 13 | Day |
2019 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035706
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