Unique ID issued by UMIN | UMIN000035564 |
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Receipt number | R000040521 |
Scientific Title | A pharmacokinetic study of major components of Matcha |
Date of disclosure of the study information | 2019/01/29 |
Last modified on | 2024/01/22 08:46:29 |
A pharmacokinetic study of major components of Matcha
A pharmacokinetic study of major components of Matcha
A pharmacokinetic study of major components of Matcha
A pharmacokinetic study of major components of Matcha
Japan |
Healthy adults
Adult |
Others
NO
To evaluate the pharmacokinetics of major components of Matcha
Pharmacokinetics
Confirmatory
Others
Not applicable
Pharmacokinetics and metabolism of major components of Matcha
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Food |
Single ingestion of test food 1-> Washout (7 days or more) -> Single ingestion of test food 2
Single ingestion of test food 2-> Washout (7 days or more) -> Single ingestion of test food 1
20 | years-old | <= |
40 | years-old | > |
Male
(1)Males whose age are 20<=years old<40.
(2)Subjects who are between 18.5 kg/m2 or more and less than 25.0 kg/m2 in BMI.
(3)Subjects who are judged to be suitable for the test by the investigator.
(1)Males whose age are 20<=years old<40.
(2)Subjects who are between 18.5 kg/m2 or more and less than 25.0 kg/m2 in BMI.
(3)Subjects who are judged to be suitable for the test by the investigator.
(1)Subjects who are with treatment at the time of Advance inspection.
(2)Subjects who have severe anemia.
(3)Subjects whose blood test values are outside of the reference range at the time of Advance inspection.
However this is not applicable to the subjects who are deemed to be able to participate in the test by the investigator.
(4)Subjects who are with allergy to the study foods or meals during the hospital stay.
(5)Subjects who are with current or past medical history of gastrointestinal disease, cardiovascular disease, nephritis and others. Subjects who are with severe mental disorder.
(6) Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test at the time of Advance inspection.
(7)Subjects who cannot stop smoking during the hospital stay.
(8)Subjects who took the OTC (including the oriental medicines), the Foods with health claims (Foods for specified health uses and others), the health foods, the supplements and others regularly within the past 1 month at the time of Advance inspection.
(9)Subjects who have potential to change the lifestyle in the test period.
(10) Subjects who donated 200mL of blood within the past 1 month or 400mL of blood within the past 3 months at the time of Advance inspection.
(11)Subjects who are attending other studies or attended other studies within the past 3 months.
(12)Subjects who are judged to be unsuitable for the test by the investigator.
15
1st name | Makoto |
Middle name | |
Last name | Kobayashi |
ITO EN, Ltd.
Central Research Institute
421-0516
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
81-548-54-1247
m-kobayasi@itoen.co.jp
1st name | Makoto |
Middle name | |
Last name | Kobayashi |
ITO EN, Ltd
Central Research Institute
421-0516
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
81-548-54-1247
m-kobayasi@itoen.co.jp
Central Research Institute, ITO EN, Ltd.
Central Research Institute, ITO EN, Ltd.
Self funding
Medical Corporation Shinanokai SHINANOZAKA CLINIC
Yotsuya Medical building, 20, samoncho, Shinjyuku, Tokyo
03-5366-3006
h-ogura@trcp.co.jp
NO
医療法人社団信濃会 信濃坂クリニック/Medical Corporation Shinanokai SHINANOZAKA CLINIC
2019 | Year | 01 | Month | 29 | Day |
not releasing
Unpublished
not releasing
15
under analysis
2020 | Year | 08 | Month | 07 | Day |
Plasma catechin concentration: slightly lower when taken with milk
Plasma theanine concentration: Simultaneous intake with milk had no effect
Healthy male
Subjects; n=15
Age;28.2
Body weight;61.3
BMI;21.0
Systolic blood pressure;111
Diastolic blood pressure;68
Pulse;71
Clinical screening,n=49
Participation,n=15
Visit1,n=15
Washout, 4 days or more
Visit2,n=15
no adverse event.
plasma catechin concentrations
plasma theanine concentrations
Completed
2019 | Year | 01 | Month | 16 | Day |
2018 | Year | 12 | Month | 26 | Day |
2019 | Year | 01 | Month | 29 | Day |
2019 | Year | 02 | Month | 07 | Day |
2022 | Year | 04 | Month | 01 | Day |
2022 | Year | 04 | Month | 15 | Day |
2022 | Year | 04 | Month | 30 | Day |
2019 | Year | 01 | Month | 16 | Day |
2024 | Year | 01 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040521
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