UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058001 |
|---|---|
| Receipt number | R000065985 |
| Scientific Title | Study on the Absorption of Food Components in the Human Body |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/02 12:49:32 |
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Basic information
Public title
Study on the Absorption of Food Components in the Human Body
Acronym
Study on the Absorption of Food Components in the Human Body
Scientific Title
Study on the Absorption of Food Components in the Human Body
Scientific Title:Acronym
Study on the Absorption of Food Components in the Human Body
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the differences in carotenoid absorption rates resulting from different vegetable processing methods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma carotenoid concentration
Key secondary outcomes
Plasma retinol and tocopherol concentrations
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
All participants were provided with standardized meals for two consecutive days prior to the intake of the test meal prepared using boiled spinach.
Interventions/Control_2
All participants were provided with standardized meals for two consecutive days, after which they consumed a test meal prepared using spinach that had been boiled and subsequently frozen.
Interventions/Control_3
All participants were provided with standardized meals for two consecutive days, after which they consumed a test meal prepared using spinach that had been boiled, subsequently frozen, and supplemented with lipids.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy male and female adults aged 18 years or older.
2)Students who are enrolled in the Gakkensai (Japan Educational Exchanges and Services: JEES) insurance program, as required by the Graduate School of Agriculture.
Key exclusion criteria
1)Pregnant or lactating women
2)Individuals with allergies to any of the 28 specified ingredients listed on the test food label
3)Smokers
4)Individuals who have taken carotenoid-related supplements or medications within the past month
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Laboratory of Quality Analysis and Assessment, Division of Agricultural Science, Graduate School of Agriculture
Zip code
606-8502
Address
Faculty of Agriculture & Life Science Building, Oiwake-cho, Kitashirakawa, Sakyo-ku, Kyoto-shi, Kyoto, Japan
TEL
0774-38-3750
hayashi.yukako.7s@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Division of Agricultural Science, Graduate School of Agriculture
Zip code
606-8502
Address
Oiwake-cho, Kitashirakawa, Sakyo-ku, Kyoto-shi, Kyoto, Japan
TEL
0774-38-3750
Homepage URL
hayashi.yukako.7s@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Nichirei Foods Inc.
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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 | 06 | Month | 01 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065985
