UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046179 |
|---|---|
| Receipt number | R000052650 |
| Scientific Title | Examination of cognitive function improving effect by ingestion of lactic acid bacteria for 12 weeks |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2024/11/20 18:49:49 |
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Basic information
Public title
12-week intake test of food containing lactic acid bacteria
Acronym
Lactic acid bacteria food intake test
Scientific Title
Examination of cognitive function improving effect by ingestion of lactic acid bacteria for 12 weeks
Scientific Title:Acronym
Cognitive function improvement test of lactic acid bacteria
Region
| Japan |
Condition
Condition
Healthy elders
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Cognitive function improvement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function improvement
Key secondary outcomes
Psychological function improvement
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Lactic bacteria containing food
Interventions/Control_2
Placebo 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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
Dementia patient
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Hisatsune |
Organization
The University of Tokyo
Division name
GSFS
Zip code
277
Address
5-1-5 Kashiwanoha, Kashiwa, Chiba
TEL
0471363632
hisatsune@edu.k.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Hisatsune |
Organization
The University of Tokyo
Division name
GSFS
Zip code
277-8562
Address
5-1-5 Kashiwanoha, Kashiwa, Chiba
TEL
0471363632
Homepage URL
hisatsune@edu.k.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GSFS, The University of Tokyo
Address
5-1-5 Kashiwanoha, Kashiwa, Chiba
Tel
04-7136-3632
hisatsune@edu.k.u-tokyo.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
| 2021 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/14/20/4300
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/14/20/4300
Number of participants that the trial has enrolled
78
Results
Significant improvements in composite memory and visual memory scores were observed in the Lactiplantibacillus plantarum OLL2712 group, after accounting for the effect of daily nutritional intake.
Results date posted
| 2024 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Older adults over the age of 65 years with declining memory.
Participant flow
Of the 81 participants, 78 completed all trials and their data were used in the analysis. The OLL2712 and placebo groups used in the analysis included 39 participants each, with no significant differences in age, sex, years of education, or BMI between the groups.
Adverse events
There were no reported harms or unintended effects in each group.
Outcome measures
The memory function was measured using the visual memory test and verbal memory test, the memory domains of Cognitrax.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052650
