Unique ID issued by UMIN | UMIN000020767 |
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Receipt number | R000023970 |
Scientific Title | Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female. |
Date of disclosure of the study information | 2016/01/27 |
Last modified on | 2018/09/05 13:26:31 |
Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.
Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.
Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.
Safety Evaluation of Long-term Intake of Powdered Tea in adult male and female.
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of long term intake of powdered tea for 12 weeks.
Safety
Hematologic test
Blood biochemistry test
Urine test
Blood pressure/pulsation
Weight/body mass index
Medical Interview
Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Consumption of powdered tea, quantity of recommended daily intake, 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 less than 110 mg/dL or 2-hour glucose levels in 75 g OGTT are less than 140 mg/dL (about 10 subjects)
B. fasting blood glucose levels are ranged 110 to 125 mg/dL or 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL (about 10 subjects)
(1) Subjects having a current or past history of serious diseases such as diabetes, hepatic or renal disorder, or cardiovascular 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
20
1st name | |
Middle name | |
Last name | Yasuto Yoshida |
YAKULT HONSHA CO., LTD
Yakult Central Institute
5-11, Izumi, Kunitachi-shi, Tokyo, Japan
042-577-8960
yasuto-yoshida@yakult.co.jp
1st name | |
Middle name | |
Last name | Shinsuke Tsuji |
TTC CO., LTD.
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
s.tsuji@ttc-tokyo.co.jp
TTC CO., LTD.
YAKULT HONSHA CO., LTD
Profit organization
NO
2016 | Year | 01 | Month | 27 | Day |
Unpublished
17 adverse events occurred in 10 out of 22 subjects, but the degree of symptoms was all mild, and relevance to research food was "None", judged by the responsible doctor.
In the clinical laboratory test values of individual subjects, inspection items that were out of the reference range were found, but it was judged that they are transient minor fluctuations and not clinically problematic fluctuations.
In addition, items with significant changes in average values of clinical laboratory test values and measured values compared to before intake were found, but in both cases there are minor fluctuations and it is not a clinically problematic fluctuation It was judged by the responsible doctor.
Based on the above results, it was shown that there is no problem on the safety during long-term ingestion of the research food "powdered tea drink" under this research condition.
Completed
2016 | Year | 01 | Month | 14 | Day |
2016 | Year | 01 | Month | 28 | Day |
2016 | Year | 01 | Month | 27 | Day |
2018 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023970
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