UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056087 |
|---|---|
| Receipt number | R000064089 |
| Scientific Title | Gut microbiota and activity of daily life to maitain cognitive functions |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/07 15:33:42 |
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Basic information
Public title
Gut microbiota and activity of daily life to maitain cognitive functions
Acronym
Gut microbiota and cognitive functions
Scientific Title
Gut microbiota and activity of daily life to maitain cognitive functions
Scientific Title:Acronym
Gut microbiota and cognitive functions
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the relationships between cognitive function, gut microbiota, and lifestyle, we will conduct cognitive function tests using an app, measure brain activity through near-infrared spectroscopy (NIRS), analyze gut microbiota from stool samples, and assess lifestyle habits through questionnaires and wearable devices. For participants who provide consent, we will also examine the effects of probiotic intake on cognitive function and lifestyle improvements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive tasks using a tablet device, stool sample collection, and brain activity measurement with a handheld NIRS device (for those who wish to participate) will be conducted from one to a maximum of six times, at intervals of 30 or 90 days. Each cognitive task will be performed over two days per session. During breaks between tablet-based cognitive tasks, participants will complete the Japanese versions of the POMS Short Form and MoCA. Participants who consent to wearing a smart ring or smartwatch will wear the device as much as possible throughout the study period. Data will be provided via the participant's smartphone.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Participants will consume a Bifidobacterium-containing food once daily for a period of 1 to 90 days.
Interventions/Control_2
Participants will consume a placebo once daily for a period of 1 to 90 days.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants must be able to operate a tablet device, must not be certified as requiring long-term care, and must not have been diagnosed with or treated for dementia or mild cognitive impairment.
Key exclusion criteria
If operating a tablet device is difficult, if the participant is certified as requiring long-term care, or if they have been diagnosed with or are being treated for dementia or mild cognitive impairment.
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kakeyama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa
TEL
04-2947-6723
kake@waseda.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kakeyama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa
TEL
04-2947-6723
Homepage URL
kake@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda uNIversity
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
Waseda University
Address
2-579-15 Mikajima, Tokorozawa
Tel
04-2947-6723
kake@waseda.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
| 2024 | Year | 11 | Month | 08 | 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
| 2024 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064089
