UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061697 |
|---|---|
| Receipt number | R000070598 |
| Scientific Title | Pharmacokinetics study of food compounds. |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 18:33:01 |
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Basic information
Public title
Pharmacokinetics study of food compounds.
Acronym
Pharmacokinetics study of food compounds.
Scientific Title
Pharmacokinetics study of food compounds.
Scientific Title:Acronym
Pharmacokinetics study of food compounds.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of food compounds.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacokinetic parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food 1 intake -> washout period -> Food 2 intake -> washout period -> Food 3 intake
Interventions/Control_2
Food 2 intake -> washout period -> Food 3 intake -> washout period -> Food 1 intake
Interventions/Control_3
Food 3 intake -> washout period -> Food 1 intake -> washout period -> Food 2 intake
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy males who are 20 years of age or older at the time of obtaining consent and under 65 years of age at the end of the intake period (2) Individuals who fully understand the purpose and details of this study and provide written informed consent
Key exclusion criteria
(1)Individuals who are currently participating in another study as study subjects, who have participated in another study within 4 weeks after its completion. (2)Individuals who fall under any of the following categories: a) Individuals who have diseases of the heart, liver, or kidneys (including when such diseases are complications of other conditions) b) Individuals with a history of cardiovascular disease c) Individuals who have developed diabetes d) Individuals who have allergies to the test food (including load food or controlled diet, etc.) e) Individuals with a history of serious diseases such as cancer or tuberculosis. (3)Individuals who are receiving any kind of medical treatment at the time of obtaining consent. (4)Individuals with reduced renal function. (5)Individuals with a history of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or intestinal resection. (6)Individuals who regularly consume Foods for Specified Health Uses (FOSHU), health food products, or other products that may affect the study results. (7)Individuals who the principal investigator determines to have difficulty swallowing capsules. (8)Individuals whose screening test results for syphilis, HBs antigen, HCV antibody, or HIV antigen/antibody are not negative. (9)Individuals who are judged by the principal investigator or sub-investigator to be unsuitable as study subjects
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | TAKEMOTO |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0238
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. 619-0284, Japan.
TEL
050-1804-0274
Daisuke_Takemoto@suntory.co.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | TAKEMOTO |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0238
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. 619-0284, Japan.
TEL
050-1804-0274
Homepage URL
Daisuke_Takemoto@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Institutional Review Board
Address
1-2-5 Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070598
