UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051171 |
|---|---|
| Receipt number | R000058250 |
| Scientific Title | A study of ingestion of lactic acid bacteria fermented product, BG/21 bacteria fermented product powder, on improvement and enhancement of cognitive function |
| Date of disclosure of the study information | 2023/05/26 |
| Last modified on | 2023/11/24 10:22:23 |
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Basic information
Public title
A study of ingestion of lactic acid bacteria fermented product, BG/21 bacteria fermented product powder, on improvement and enhancement of cognitive function
Acronym
A study of ingestion of lactic acid bacteria fermented product powder on improvement and enhancement of cognitive function
Scientific Title
A study of ingestion of lactic acid bacteria fermented product, BG/21 bacteria fermented product powder, on improvement and enhancement of cognitive function
Scientific Title:Acronym
A study of ingestion of lactic acid bacteria fermented product powder on improvement and enhancement of cognitive function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the improvement and enhancement effects of cognitive function by ingestion of lactic acid bacteria fermented product powder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuro-Psychological test
Key secondary outcomes
Fecal short chain fatty acid content, sleep-related questionnaire, stress-related questionnaire, defecation-related questionnaire, height, weight, BMI
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
The subjects ingest the active products for twelve weeks.
Interventions/Control_2
The subjects ingest the placebo products for twelve weeks.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 40 to 85 years old
2) individuals who are concerned about forgetfulness
3) individuals who can refrain from overeating and drinking
4) individuals who can make self-judgement and are voluntarily giving written informed consent
Key exclusion criteria
Individuals who
1) can't stop intake health foods and supplements that affect the intestinal flora during the test period
2) are suffering from or undergoing treatment for serious infections
3) have a chronic bowel disease and regularly use drugs such as antibiotics
4) can't stop intake large amount of lactic acid bacteria beverages and lactic acid bacteria foods such as yogurt during the test period
5) may have an allergic reaction to the test product ingredients
6) are pregnant, intend to become pregnant during the test period, are breastfeeding
7) have difficulty maintaining lifestyle habits (eating, exercising, sleeping,skin care, etc)
8) are participating in or willing to participate in, a test involving the consumption of other foods, the use of drugs, or a test involving the application of cosmetics or drugs
9) have an allergic reaction to soybeans or dairy products
10) have difficulty filling in the subject diary
11) are judged as unsuitable for the current study by the investigator for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
Univercity of Nagasaki
Division name
Regional Partnership Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 8512195
TEL
0958135216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yamaguchi |
Organization
Univercity of Nagasaki
Division name
General Affairs and Planning Division
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 8512195
TEL
0958135500
Homepage URL
tyamagu@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Biogenomics 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
Univercity of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 8512195
Tel
0958135500
soumu-g@sun.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
| 2023 | Year | 05 | Month | 26 | 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
60
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058250
