UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060216 |
|---|---|
| Receipt number | R000068755 |
| Scientific Title | A study on the effects of cognitive training on the intestinal environment |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/26 19:03:53 |
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Basic information
Public title
The effects of cognitive training on the intestinal environment
Acronym
The effects of cognitive training on the intestinal environment
Scientific Title
A study on the effects of cognitive training on the intestinal environment
Scientific Title:Acronym
A study on the effects of cognitive training on the intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of brain activation induced by cognitive training on the gut environment during middle age
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal microbiome
Fecal metabolites
Key secondary outcomes
Memory test score
Fecal form (Rome Foundation's Bristol Stool Form Scale)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Face Name Associative Memory Exam
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged between 40 and 60 years.
2. Individuals who do not regularly engage in brain training; however, individuals who have not engaged in brain training for at least six months are eligible to participate.
3. Individuals who voluntarily agreed to participate in the study after receiving ufficient explanation and providing written informed consent
Key exclusion criteria
1. Individuals who currently require medication or regular medical visits
2. Individuals undergoing dietary or exercise therapy under medical supervision.
3. Individuals with current or past history of serious diseases
4. Individuals who regularly consume over-the-counter medications, quasi-drugs, dietary supplements, or foods with health claims such as Foods for Specified Health Uses (FOSHU) or Foods with Functional Claims (FFC); however, those who are able to discontinue such use after giving consent may be eligible to participate.
5. Individuals with drug or food allergies.
6. Individuals who have donated blood components or 200 mL of whole blood within one month prior to the start of the study.
7. Individuals who have donated 400 mL of whole blood within four months prior to the start of the study.
Individuals who have participated in other clinical trials or clinical studies within one month prior to obtaining informed consent, are currently participating, or plan to participate during the study period.
9. Women who are currently pregnant or breastfeeding, or who plan to become pregnant during the study period."
10. Individuals with habitual excessive alcohol consumption (>=60 grams of ethanol per day).
11. Individuals with irregular lifestyles, including those with highly irregular eating habits, shift work, or night shifts
12. Individuals with constipation or a tendency toward constipation who are deemed unable to submit stool samples for this trial
13. Individuals who regularly engage in brain training, including free or paid brain training apps, memory games, and brain training drills from books and magazines; however, individuals who have not engaged in brain training for at least six months are eligible to participate.
14. Individuals judged by the principal medical doctor to be inappropriate for participation in the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyodo Milk Industry Co., Ltd.
Division name
Research Laboratories
Zip code
190-0182
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo
TEL
042-597-5911
m-matumoto@meito.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takahama |
Organization
Seishukai Clinic
Division name
Clinical trial office
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
080-4410-9269
Homepage URL
t-takahama@seishukai.or.jp
Sponsor or person
Institute
Kyodo Milk Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry Co., Ltd.
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
Seishukai Clinic Institutional Review Board
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
Tel
080-4410-9269
t-takahama@seishukai.or.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 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2026 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068755
