UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060430 |
|---|---|
| Receipt number | R000069132 |
| Scientific Title | Elucidation of dietary signal molecules through collection of human gastrointestinal tract contents |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/21 20:42:37 |
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Basic information
Public title
Elucidation of dietary signal molecules through collection of human gastrointestinal tract contents
Acronym
Elucidation of dietary signal molecules through collection of human gastrointestinal tract contents
Scientific Title
Elucidation of dietary signal molecules through collection of human gastrointestinal tract contents
Scientific Title:Acronym
Elucidation of dietary signal molecules through collection of human gastrointestinal tract contents
Region
| Japan |
Condition
Condition
healthy adult volunteers
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, gastric contents will be collected from humans after ingestion of a model food, and the resulting molecular profiles will be comprehensively analyzed using liquid chromatography-mass spectrometry. This approach enables the direct identification of molecules that are actually generated within the human gastrointestinal tract. Furthermore, by comparing these results with those obtained from in vitro simulated digestion experiments and analyses of gastrointestinal contents from mouse models, a more accurate evaluation and validation of digestive simulations can be achieved.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Peptide analysis of gastric contents
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food | Maneuver |
Interventions/Control_1
After oral ingestion of a test meal composed of protein components, upper gastrointestinal endoscopy (EGD) will be performed to collect digested gastric contents.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will be recruited from among the principal investigator, co-investigators, and members affiliated with the Laboratory of Food Physiological Functions, Division of Food Science and Biotechnology, Graduate School of Agriculture, Kyoto University, who voluntarily express their willingness to participate in the study.
Key exclusion criteria
Individuals with diseases under active medical treatment will be excluded. However, individuals whose conditions are well controlled by medication will not be excluded.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Kousaku |
| Middle name | |
| Last name | Ohinata |
Organization
Graduate School of Agriculture, Kyoto University
Division name
Division of Food Science and Biotechnology
Zip code
611-0011
Address
Gokasho, Uji, Kyoto, Japan
TEL
0774-38-3733
ohinata.kousaku.3n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Rentaro |
| Middle name | |
| Last name | Inoue |
Organization
Graduate School of Agriculture, Kyoto University
Division name
Division of Food Science and Biotechnology
Zip code
611-0011
Address
Gokasho, Uji, Kyoto, Japan
TEL
0774-38-3733
Homepage URL
inoue.rentaro.45c@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Utsumi Takahiro
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 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
| 2026 | Year | 01 | Month | 21 | 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 | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 09 | 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 | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069132
