UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063183 |
|---|---|
| Receipt number | R000072076 |
| Scientific Title | Exploratory Comparative Study on Bioavailability of the Research Food Through Continuous Intake: A Randomized, Open-label, Parallel-group Trial |
| Date of disclosure of the study information | 2026/10/06 |
| Last modified on | 2026/10/06 00:22:57 |
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Basic information
Public title
Exploratory Comparative Study on Bioavailability of the Research Food Through Continuous Intake: A Randomized, Open-label, Parallel-group Trial
Acronym
Exploratory Comparative Study on Bioavailability of the Research Food Through Continuous Intake
Scientific Title
Exploratory Comparative Study on Bioavailability of the Research Food Through Continuous Intake: A Randomized, Open-label, Parallel-group Trial
Scientific Title:Acronym
Exploratory Comparative Study on Bioavailability of the Research Food Through Continuous Intake
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily compare the bioavailability of the research foods after continuous intake.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood concentration of the ingredient derived from the research food
Key secondary outcomes
Blood kinetics-related parameters of the ingredient derived from the research food
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food for 2 weeks.
Interventions/Control_2
Intake of the control food for 2 weeks.
Interventions/Control_3
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men aged 40-59, or postmenopausal women aged 40-59
2. BMI >=18.5 kg/m^2 and <25.0 kg/m^2
3. Provided written informed consent
Key exclusion criteria
1. Under treatment for any disease, or current or past history of serious disease
2. Allergy to the research food
3. Regular use of health foods or supplements (unless discontinued during the study)
4. Unsuitable for blood sampling, or blood donation/collection exceeding the specified volume within a defined period before the study
5. Participating or planning to participate in another clinical study
6. Otherwise judged unsuitable by the principal investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Oikawa |
Organization
Comfo-Garden Clinic
Division name
Chairman
Zip code
162-0054
Address
3-2 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-5368-6980
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku-ku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.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 | 10 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 09 | 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 | 10 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072076
