Unique ID issued by UMIN | UMIN000051827 |
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Receipt number | R000059047 |
Scientific Title | Blood kinetics study of a single intake of the test food in healthy adult male subjects. |
Date of disclosure of the study information | 2023/08/04 |
Last modified on | 2024/02/02 10:18:46 |
Blood kinetics study of a single intake of the test food in healthy adult male subjects.
Blood kinetics study of a single intake of the test food in healthy adult male subjects.
Blood kinetics study of a single intake of the test food in healthy adult male subjects.
Blood kinetics study of a single intake of the test food in healthy adult male subjects.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the blood kinetics of active ingredients during a single intake of the test food.
PK,PD
Blood kinetics
(Cmax)
Blood kinetics
(Blood concentration, AUC, Tmax, T1/2)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Intake of the test food.
20 | years-old | <= |
35 | years-old | > |
Male
1) Age, Sex: 20-34, healthy male
2) BMI: 18.5 kg/m2-24.9 kg/m2
3) Subjects who can participate in dietary interventions, intake of the test foods, blood samplings, urine samplings, and maintain rest as scheduled.
4) Subjects who voluntarily give written informed consent.
1)Subjects with a serious medical history, or with a history of disorders of the digestive system, circulatory system (e.g., heart failure), endocrine system, etc. Subjects who have been judged to be inappropriate for the study by the principal investigator.
2)Subjects who have a history of gastrointestinal resection surgery, excluding appendectomy.
3)Subjects who are currently taking medication or being treated by a physician.
4)Subjects who must be scheduled to receive medical treatment or medication during the study period.
5)Subjects who plan to consume health foods or supplements other than the food under study after consent.
6)Subjects who are unable to consume the test food due to preference or allergy. Subjects who may have allergies related to the test food.
7)Heavy drinkers of alcohol and smokers.
8)Subjects who donated blood over 200mL in the past 4 weeks or over 400mL in the past 12 weeks.
9)Subjects who currently or will be participating in another clinical research study during the study period.
10)Subjects who have irregular sleep or eating habits due to night work or insomnia.
11)Subjects who are engaged in strenuous physical activity.
12)Subjects judged as unsuitable for the study by the responsible doctor for other reasons.
10
1st name | Sayuri |
Middle name | |
Last name | Matsuoka |
FANCL Corporation
Research Institute
244-0806
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
045-820-3449
matsuoka@fancl.co.jp
1st name | Naoyuki |
Middle name | |
Last name | Abe |
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Clinical Trial Division
003-0011
7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
011-868-2711
n-abe@medi-ate.jp
FANCL Corporation
FANCL Corporation
Profit organization
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Institutional Review Board
Ito-Yokado Fukuzumi 5F, 1-2-5 Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan
011-836-3531
n-abe@medi-ate.jp
NO
2023 | Year | 08 | Month | 04 | Day |
Unpublished
Completed
2023 | Year | 07 | Month | 25 | Day |
2023 | Year | 08 | Month | 07 | Day |
2023 | Year | 08 | Month | 08 | Day |
2023 | Year | 09 | Month | 30 | Day |
2023 | Year | 08 | Month | 04 | Day |
2024 | Year | 02 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059047
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