UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055995 |
|---|---|
| Receipt number | R000063994 |
| Scientific Title | The effects of Lactiplantibacillus plantarum 22A-3 intake on male university soccer players. |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2025/04/30 09:16:35 |
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Basic information
Public title
The effects of Lactiplantibacillus plantarum 22A-3 intake on male university soccer players.
Acronym
The effects of Lactiplantibacillus plantarum 22A-3 intake on male university soccer players.
Scientific Title
The effects of Lactiplantibacillus plantarum 22A-3 intake on male university soccer players.
Scientific Title:Acronym
The effects of Lactiplantibacillus plantarum 22A-3 intake on male university soccer players.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of intake of the test food on male university soccer players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaires on the mental and physical health status.
Key secondary outcomes
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
Oral intake of test food (Once a day; 8 weeks).
Interventions/Control_2
Oral intake of placebo food (Once a day; 8 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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Male students who belong to the soccer club in Toin Yokohama University.
2.Participants who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
Key exclusion criteria
1.Participants who may experience allergic reactions to the components contained in the test food.
2.participants whose physical activity is restricted due to injuries.
3.participants who do not have comparative data between pre-intake data of the test food and post-intake data due to injuries or other reasons.
4.Participants taking medication for gastrointestinal diseases.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Narita |
Organization
Toin University of Yokohama
Division name
Department of Sport Technology Faculty of Culture and Sport Policy
Zip code
225-8503
Address
1614 Kurogane-cho Aoba-ku Yokohama Kanagawa
TEL
+81459745792
t-narita@toin.ac.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Narita |
Organization
Toin University of Yokohama
Division name
Department of Sport Technology Faculty of Culture and Sport Policy
Zip code
225-8503
Address
1614 Kurogane-cho Aoba-ku Yokohama Kanagawa
TEL
+81459745792
Homepage URL
t-narita@toin.ac.jp
Sponsor or person
Institute
Toin University of Yokohama
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
Toin University of Yokohama Clinical Research Ethics Review Committee
Address
1614 Kurogane-cho Aoba-ku Yokohama Kanagawa
Tel
+81459745605
research@toin.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
| 2024 | Year | 10 | Month | 31 | 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
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063994
