UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057973 |
|---|---|
| Receipt number | R000066245 |
| Scientific Title | Detection of early biological responses induced by ingestion of a food ingredients that activate gastrointestinal vagal afferent pathways (preliminary study) |
| Date of disclosure of the study information | 2026/05/31 |
| Last modified on | 2025/05/26 18:19:20 |
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Basic information
Public title
Detection of early biological responses induced by a food component (preliminary study)
Acronym
Detection of early biological responses induced by a food component (preliminary study)
Scientific Title
Detection of early biological responses induced by ingestion of a food ingredients that activate gastrointestinal vagal afferent pathways (preliminary study)
Scientific Title:Acronym
Detection of early biological responses induced by ingestion of a food ingredients that activate gastrointestinal vagal afferent pathways (preliminary study)
Region
| Japan |
Condition
Condition
Male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the potential of blood testing to detect changes in proteins induced by a food component that activates vagal afferents through stimulation of enteroendocrine cells.
Basic objectives2
Others
Basic objectives -Others
Evaluation of analytical strategy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentrations of proteins downstream of signaling pathways stimulated by the test food component
Key secondary outcomes
Plasma concentrations of gastrointestinal hormones
Correlation between plasma concentrations of proteins and gastrointestinal hormones that showed significant expression changes in the primary endpoints
Changes in the plasma proteome associated with the ingestion of the test food component
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of the test food -> 2-week washout period -> Single intake of the placebo
Interventions/Control_2
Single intake of the placebo -> 2-week washout period -> Single intake of the test food
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Healthy males aged 20 to below 60 years at the time of consent acquisition.
2.Office workers
3.Subjects whose average sleep duration is over 6 hours
4.Subjects whose day-to-day variability in bedtime and wake-up time on weekdays is within 2 hours.
5.Subjects who can go to bed before midnight on the day before the test.
6.Subjects who commute by walking or biking (with the duration of approx. 5 to 30 minutes)
7.Subjects who give written informed consent, after receiving a detailed explanation of the study protocol and understanding the provided information.
Key exclusion criteria
1.Subjects with a history or current diagnosis of mental disorders, chronic fatigue syndrome, sleep disorders, brain injury, brain dysfunction, learning disabilities, or dementia.
2.Subjects with a history or current diagnosis of diabetes, liver disease, kidney disease, heart disease, respiratory disease, diseases affecting adrenal cortex hormone secretion, or other metabolic diseases.
3.Subjects who are currently undergoing medication treatment.
4.Subjects who have smoking habits.
5.Subjects who daily take excessive alcohol.
6.Subjects who are unable to refrain from exercise on the test day (excluding physical activity related to commuting) until the end of blood sampling.
7.Subjects whose sleep environment may change significantly due to long-term business trips or travel during the study period.
8.Subjects who have a participation in other clinical trials within the last 4 weeks or are intended to participate.
9.Subjects who have allergies to medications and/or food.
10.Subjects who have been considered ineligible for participation in the trial by the investigators.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Matsuda |
Organization
Yakult Honsha Co., Ltd.
Division name
Food Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, Japan
TEL
042-577-8946
kazunori-matsuda@yakult.co.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Matsuda |
Organization
Yakult Honsha Co., Ltd.
Division name
Food Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, Japan
TEL
042-577-8946
Homepage URL
kazunori-matsuda@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co., Ltd.
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
Ethical Review Committee for Research Involving Human Subjects, Yakult Honsha Co., Ltd.
Address
5-11 Izumi, Kunitachi-shi, Tokyo, Japan
Tel
042-577-8960
kenta-suzuki@yakult.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 | 05 | Month | 31 | 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 | 04 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 08 | 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 | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066245
