UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055377 |
|---|---|
| Receipt number | R000063286 |
| Scientific Title | Effects of Lactococcus lactis H61 supplementation on conditioning indices |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2025/05/21 11:18:35 |
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Basic information
Public title
Effects of 8-week ingestion of Lactococcus lactis H61 supplements on stress status in collegiate baseball players
Acronym
The effect of Lactococcus lactis H61 on stress status
Scientific Title
Effects of Lactococcus lactis H61 supplementation on conditioning indices
Scientific Title:Acronym
The effect of Lactococcus lactis H61 on stress status
Region
| Japan |
Condition
Condition
Collegiate baseball players
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of 8-week ingestion of Lactococcus lactis H61 supplements on stress status in collegiate baseball players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary secretory immunoglobulin A levels
Key secondary outcomes
1) Salivary cortisol levels
2) Stress markers in facial hair
3) Subjective fatigue status
4) Sleep quality
5) Subjective mood status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
8-week placebo ingestion
Interventions/Control_2
8-week ingestion of Lactococcus lactis H61 supplements
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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Who belongs to the baseball club of the University of Tsukuba
2) Who has not habitually utilized commercial supplements or beverages that contain Lactobacillus or gamma-amino butyric acid
3) Who does not have lactose intolerance
4) Who does not habitually smoke
5) Who does not habitually take medicine
6) Who can consent to participate in the study
Key exclusion criteria
1) Who cannot comply with the study protocol
2) Who receives vaccination during the study period
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keisei |
| Middle name | |
| Last name | Kosaki |
Organization
University of Tsukuba
Division name
Institute of Health and Sports Science
Zip code
3058574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-5990
kosaki.keisei.gm@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Keisei |
| Middle name | |
| Last name | Kosaki |
Organization
University of Tsukuba
Division name
Institute of Health and Sports Science
Zip code
3058574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-5990
Homepage URL
kosaki.keisei.gm@u.tsukuba.ac.jp
Sponsor or person
Institute
Institute of Health and Sports Science, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Agriculture and Food Research Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
+81-29-853-5990
kosaki.keisei.gm@u.tsukuba.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 | 08 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 28 | 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 | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063286
