UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056164 |
|---|---|
| Receipt number | R000064175 |
| Scientific Title | Verification of impacts on psychological state by lactic acid bacteria intakes. |
| Date of disclosure of the study information | 2025/11/14 |
| Last modified on | 2024/11/15 13:04:23 |
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Basic information
Public title
Verification of impacts on psychological state by lactic acid bacteria intakes.
Acronym
Verification of impacts on psychological state by lactic acid bacteria intakes.
Scientific Title
Verification of impacts on psychological state by lactic acid bacteria intakes.
Scientific Title:Acronym
Verification of impacts on psychological state by lactic acid bacteria intakes.
Region
| Japan |
Condition
Condition
Healthy male/female subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify some kind of effect on psychological state by test-food intakes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain waves
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Intake test food on the day.
Wash out.
Intake placebo food on the day.
Interventions/Control_2
Intake placebo food on the day.
Wash out.
Intake test food on the day.
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Japanese males and females aged 20 or more and less than 45 at the time of written informed consent.
(2) Subjects who have normal eyesight (including corrected eyesight) and hearing ability.
(3) Subjects with no allergy to dairy products or fermented foods.
(4) Subjects who can avoid consuming lactic acid bacteria beverages or fermented food containing lactic acid bacteria for three days prior to participating in the study.
(5) Subjects whose daily rhythm is not extremely irregular.
(6) Subjects with a BMI of 18.5 or more but less than 30.
(7) Subjects who do not consume excessive amounts of alcohol.
(8) Subjects who do not smoke excessively.
(9) Subjects who do not consume excessive amounts of caffeine.
(10) Subjects who have never suffered external head injuries severe enough to cause loss of consciousness.
Key exclusion criteria
(1) Subjects with a history of cardiovascular disease, psychiatric disorder, gastrointestinal disorder, or a serious disease.
(2) Subjects who are currently being treated for an illness or injury or who are taking regular medication.
(3) Subjects who had significant health problems in the two months leading up to the day of participation.
(4) Subjects whose social life is affected by irritability, drowsiness, bad mood, abdominal pain, constipation/diarrhea, fatigue, etc. associated with menstruation.
(5) Subjects who are planning to get pregnant during the test period after the day of informed consent or are currently pregnant and lactating.
(6) Subjects who have or had infected with COVID-19 within the past two weeks, or who live with someone who has or had infected with COVID-19 within the past two weeks.
(7) Subjects who have experienced a major life event within the three months prior to obtaining consent, or who have plans to do so during the trial period.
(8) Subjects who are participating in other clinical trials at the time of obtaining consent, and who plan to participate in other clinical trials within 3 months from the end of the study to the start of the main study of the study, or after consenting to participate in the study.
(9) Subjects being determined as ineligible for participation by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kurashige |
Organization
Centan Inc.
Division name
Research and Development
Zip code
108-0075
Address
11F, Shinagawa East One Tower, 2-16-1, Konan, Minato city, Tokyo
TEL
03-6670-6722
kurashige@centan.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kurashige |
Organization
Centan Inc.
Division name
Research and Development
Zip code
108-0075
Address
11F, Shinagawa East One Tower, 2-16-1, Konan, Minato city, Tokyo
TEL
03-6670-6722
Homepage URL
kurashige@centan.jp
Sponsor or person
Institute
Centan Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Public Health Research Foundation
Address
1-1-7, Nishi-Waseda, Shinjyuku city, Tokyo
Tel
03-5287-5070
rinri@phrf.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
| 2025 | Year | 11 | Month | 14 | 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 | 14 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 22 | 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 | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064175
