Unique ID issued by UMIN | UMIN000046259 |
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Receipt number | R000052697 |
Scientific Title | A study to investigate the blood kinetics of food material |
Date of disclosure of the study information | 2021/12/03 |
Last modified on | 2022/12/03 10:21:18 |
A study to investigate the blood kinetics of food material
A study to investigate the blood kinetics of food material
A study to investigate the blood kinetics of food material
A study to investigate the blood kinetics of food material
Japan |
Healthy volunteers
Not applicable | Adult |
Others
NO
To investigate the blood kinetics after single intake of food material
Others
Blood kinetics
blood concentration of effective substance
blood concentration of lipid parameters
Interventional
Cross-over
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Active
2
Prevention
Food |
Single intake of test food 1 -> washout period -> Single intake of test food 2
Single intake of test food 2 -> washout period -> Single intake of test food 1
20 | years-old | <= |
60 | years-old | >= |
Male and Female
1) Males and females aged 20-60 years
2) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
1) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects who go to the hospital with lifestyle-related diseases (high blood pressure, dyslipidemia, diabetes, etc.)
3) Subjects who have the possibility of developing allergic symptoms by the test food
4) Subjects who have the plan to change their lifestyle
5) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
6) Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
7) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
8) Subjects deemed unsuitable by the investigator
10
1st name | Yuki |
Middle name | |
Last name | Higa |
Kobayashi Pharmaceutical Co., Ltd.
Central R&D Laboratory
567-0057
1-30-3, Toyokawa, Ibaraki-shi, Osaka
080-3499-8782
y.higa@kobayashi.co.jp
1st name | Tomohiro |
Middle name | Sugino |
Last name | Sugino |
Soiken Inc.
R&D Division
560-0082
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc.
Kobayashi Pharmaceutical Co., Ltd.
Profit organization
IRB of Fukuda Clinic
Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka, Osaka
06-6398-0203
fukudaclinicIRB@gmail.com
NO
2021 | Year | 12 | Month | 03 | Day |
Unpublished
Completed
2021 | Year | 11 | Month | 20 | Day |
2021 | Year | 11 | Month | 20 | Day |
2021 | Year | 12 | Month | 05 | Day |
2021 | Year | 12 | Month | 19 | Day |
2021 | Year | 12 | Month | 02 | Day |
2022 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052697
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