Unique ID issued by UMIN | UMIN000028776 |
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Receipt number | R000032935 |
Scientific Title | Safety evaluation of excessive intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function |
Date of disclosure of the study information | 2017/08/22 |
Last modified on | 2018/09/05 13:45:12 |
Safety evaluation of excessive intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function
Safety evaluation of excessive intake of drink containing plant-derived anthocyanin
Safety evaluation of excessive intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver function
Safety evaluation of excessive intake of drink containing plant-derived anthocyanin
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of excessive intake of drink containing plant-derived anthocyanin, 3-fold quantity of recommended daily intake (480 g), for 4 weeks
Safety
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Intake of drink containing plant-derived anthocyanin, 3-fold quantity of recommended daily intake, for 4 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Males and females from 20 to 64 years of age
(2) The liver function test value at the time of preliminary examination corresponds to the normal range or health guidance judgment value, and subjects who judged by a healthy person and a doctor from other inspection results
A. Subjects who satisfy all conditions of ALT 30 U/L or less, AST 30 U/L or less and gamma-GT 50 U/L or less (10 subjects)
B. Subjects who satisfy under at least one of the conditions of ALT 31 U/L or more, AST 31 U/L or more, or gamma-GT 51 U/L or more (10 subjects)
(1) Subjects who constantly use health food richly containing involvement ingredient
(2) Subjects who constantly use supplements or drugs affecting the liver function
(3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(4) Subjects having possibilities for emerging allergy related to the study
(5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(7) 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
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the study by the investigator for other reasons
20
1st name | |
Middle name | |
Last name | Mitsuyoshi Kano |
YAKULT HONSHA CO., LTD
Research Management Center Yakult Central Institute
5-11, Izumi, Kunitachi-shi, Tokyo, Japan
042-577-8960
mitsuyoshi-kano@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
2017 | Year | 08 | Month | 22 | Day |
Unpublished
Adverse events occurred in 6 out of 20 adults, but there were no serious adverse events, symptoms were all mild, all relevance to research food was "none", judged by the responsible physician It was done.
In addition, items with significant changes in mean values of clinical laboratory test values and measured values compared to before ingestion were found, but all of them were slightly fluctuating and not as clinically problematic fluctuations It was judged by the responsible doctor.
Based on the above results, it was shown that there is no problem on the safety of over-ingestion of plant-derived anthocyanin-containing beverages under this research condition.
Completed
2017 | Year | 08 | Month | 10 | Day |
2017 | Year | 08 | Month | 23 | Day |
2017 | Year | 08 | Month | 22 | Day |
2018 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032935
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