UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052940 |
|---|---|
| Receipt number | R000060406 |
| Scientific Title | Additional analysis of a study to confirm the effect of continuous consumption of beverages containing bifidobacteria and dietary fiber on improving cognitive function |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/12/12 15:18:59 |
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Basic information
Public title
Additional analysis of a study to confirm the effect of continuous consumption of beverages containing bifidobacteria and dietary fiber on improving cognitive function
Acronym
Additional analysis of a study to confirm the effect of continuous consumption of beverages containing bifidobacteria and dietary fiber on improving cognitive function
Scientific Title
Additional analysis of a study to confirm the effect of continuous consumption of beverages containing bifidobacteria and dietary fiber on improving cognitive function
Scientific Title:Acronym
Additional analysis of a study to confirm the effect of continuous consumption of beverages containing bifidobacteria and dietary fiber on improving cognitive function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the relationship between inflammation and gut microbiota as a mechanism of action for improving cognitive function to increase the credibility of the evidence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota and genes
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects examined in the other study (UMIN000048386)
Key exclusion criteria
Subjects whose specimen did not be obtained in the other study (UMIN000048386).
Subjects whose enterobacterial DNA sequence data did not meet quality criteria.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Saito |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
TEL
05017466514
yasuo.saito@glico.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Azuma |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
TEL
050-1746-0412
Homepage URL
naoki.azuma@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
Tel
05017454027
toshihiko.koike@glico.com
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 | 09 | Month | 30 | Day |
Related information
URL releasing protocol
https://doi.org/10.12938/bmfh.2025-026
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.12938/bmfh.2025-026
Number of participants that the trial has enrolled
63
Results
Feces from participants in other clinical trial (UMIN000048386) were analyzed for gut microbiota. The results revealed that the administration of Bifidobacterium animalis subsp. lactis GCL2505 and inulin increased short-chain fatty acid-producing bacteria in the gut, such as genus Faecalibacterium and Bifidobacterium.
Results date posted
| 2025 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Number of Per Protocol Set: 63
Adverse events
Nothing
Outcome measures
Gut microbiota and genes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 11 | Month | 30 | Day |
Other
Other related information
This study is conducted using specimens obtained in the other study (UMIN000048386). There is no intervention and invasion in this study.
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060406
