UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059837 |
|---|---|
| Receipt number | R000068429 |
| Scientific Title | Research on the bioavailability of some functional components after test food intake in healthy subjects |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/20 16:56:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on the bioavailability of some functional components after test food intake in healthy subjects
Acronym
Research on the bioavailability of some functional components after test food intake in healthy subjects
Scientific Title
Research on the bioavailability of some functional components after test food intake in healthy subjects
Scientific Title:Acronym
Research on the bioavailability of some functional components after test food intake in healthy subjects
Region
| Japan |
Condition
Condition
Healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the absorption of some functional components after single intake of test foods
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements at each time point in blood and urine, area under the curve (AUC), and maximum concentration (Cmax)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food A > Single intake of test food B > Single intake of test food C
Interventions/Control_2
Single intake of test food B > Single intake of test food C > Single intake of test food A
Interventions/Control_3
Single intake of test food C > Single intake of test food A > Single intake of test food B
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
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy males aged 20 to 74 years
(2) Individuals who voluntarily agree to participate in the clinical trial and are able to provide written informed consent.
(3) Individuals who are able to maintain their usual lifestyle habits consistently throughout the study period.
Key exclusion criteria
1) Individuals with serious diseases such as diabetes, cardiovascular disease, liver disease, kidney disease, cancer, or psychiatric disorders.
2) Individuals with a history of serious diseases such as diabetes, cardiovascular disease, liver disease, kidney disease, or cancer.
3) Individuals who have donated more than 200 mL of blood in the past month, or more than 400 mL in the past three months.
4) Individuals who have previously experienced discomfort or adverse effects from blood collection, or who have been told that blood collection may be difficult due to small veins.
5) Individuals with severe anemia.
6) Individuals whose dietary intake or physical activity varies significantly, making it difficult to maintain usual lifestyle habits.
7) Individuals with known or suspected food or drug allergies to the test food.
8) Individuals who routinely consume foods with functional claims, health foods, or dietary supplements and are unable to discontinue their intake during the study period.
9) Other individuals deemed ineligible for participation by the principal investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition clinic
Zip code
170-0003
Address
3-24-3 Komagome, Toshima-ku, Tokyo, Japan
TEL
03-3918-6181
kamachi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness Inc.
Division name
Representative Director
Zip code
173-0004
Address
2-63-9-401 Itabashi, Itabashi-ku, Tokyo, Japan
TEL
070-3023-8214
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Bio-oriented Technology Research Advancement Institution, NARO
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Research Ethics Committee of Kagawa Nutrition University
Address
3-9-21, Chiyoda, Sakado, Saitama, Japan
Tel
049-289-6041
kenshien@eiyo.ac.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
| 2025 | Year | 11 | Month | 20 | 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
| 2025 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068429
