UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051973 |
|---|---|
| Receipt number | R000059319 |
| Scientific Title | Exploratory study on the effects of lactic acid bacteria intake on mental and physical functions. |
| Date of disclosure of the study information | 2023/10/17 |
| Last modified on | 2024/07/30 13:41:34 |
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Basic information
Public title
Exploratory study on the effects of lactic acid bacteria intake on mental and physical functions.
Acronym
Exploratory study on the effects of lactic acid bacteria intake on mental and physical functions.
Scientific Title
Exploratory study on the effects of lactic acid bacteria intake on mental and physical functions.
Scientific Title:Acronym
Exploratory study on the effects of lactic acid bacteria intake on mental and physical functions.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective is to explore the effects of lactic acid bacteria intake on mental and physical functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Self-reported questionnaires on the mental and physical health status.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take the test food once a day for 12 weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Healthy Japanese volunteers (male/female) aged 18 years or older at time of informed consent
(2)Those who have already given written consent to participate in MYCODE study (the research aimed at improving health and longevity in Japan using data of the customers of MYCODE, a personal genome service).
(3)Those who have received a sufficient explanation of the purpose of this study, have the ability to consent, are able to voluntarily apply for participation after having a good understanding of this study, and have given content for this study.
Key exclusion criteria
(1)Subjects who are receiving continuous pharmaceutical treatment
(2)Subjects with previous and/or current medical history of serious disease (e.g. liver, kidney, heart, lung, blood)
(3)Females who are pregnant and/or lactating, or those who may become pregnant
(4)Subjects who plan to have irregular life cycle (e.g. midnight shift work, long-term travel) and/or those with extremely irregular dining and sleeping habits
(5)Subjects who have a habit of taking foods containing Lactobacillus strains , which will be used in this study
(6)Subjects who are participating in other clinical studies at the start of this study, or subjects who plan to participate in other clinical studies after providing consent for this study
(7)Subjects who are judged unsuitable by the principal investigator
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Sunada |
Organization
DeNA Life Science, Inc
Division name
Member of the Board
Zip code
150-6140
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
TEL
03-4366-7219
IRB_dls@dena.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Matsuda |
Organization
DeNA Life Science, Inc
Division name
MYCODE service Dept
Zip code
150-6140
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
TEL
03-4366-7219
Homepage URL
IRB_dls@dena.com
Sponsor or person
Institute
DeNA Life Science Inc.
Institute
Department
Personal name
Funding Source
Organization
HOUSE WELLNESS FOODS CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
HOUSE WELLNESS FOODS CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
DeNA Life Science, Inc. Ethics Review Committee
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
Tel
03-4366-7219
IRB_dis@dena.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
| 2023 | Year | 10 | Month | 17 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | 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 | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059319
