UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027576 |
|---|---|
| Receipt number | R000031608 |
| Scientific Title | Research on mental stress and physical exercise function |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2025/03/24 10:09:34 |
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Basic information
Public title
Research on mental stress and physical exercise function
Acronym
Research on mental stress and physical exercise function
Scientific Title
Research on mental stress and physical exercise function
Scientific Title:Acronym
Research on mental stress and physical exercise function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on the effects of a freshener on mental and physical conditions under chronic stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate effects of beverage ingestion on mental and physical conditions at 6,12, 18 and 24 weeks into intervention by Stress-related Questionnaire and measurement items
Key secondary outcomes
Evaluate effects of beverage ingestion on fatigue and the abdominal symptoms at 6,12, 18 and 24 weeks into intervention by Stress-related Questionnaire and measurement items
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
Daily intake of a refreshener including LAB for 24 weeks
Interventions/Control_2
Daily intake of a refreshener without LAB for 24 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
| Not applicable |
Gender
Male
Key inclusion criteria
Subjects are without major problems in psychological and physical health.
Key exclusion criteria
1. Subjects having history of psychiatric or somatic diseases in the past and present.
2. Subjects taking medication at least for three months prior to the enrollment and during the experimental period.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Rokutan |
Organization
Tokushima University
Division name
Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9004
rokutan@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Nishida |
Organization
Tokushima University
Division name
Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9004
Homepage URL
knishida@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, 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
Clinical Trial Center For Development Therapeutics
Address
2-50-1 Kuramotocho, Tokushima city
Tel
088-633-9294
awachiken@tokushima-u.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
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
34
Results
The group that took the soft drink (containing lactobacilli) daily for 24 weeks showed significantly less physical fatigue and improved mental health compared to the group that took the placebo drink.
Results date posted
| 2024 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
LAB taking group
Number of participants:17
Age: 19.6+-0.9 (mean+-SD)
Sex: 17 males, 0 females
Placebo taking group
Number of participants: 17
Age: 19.4+-0.9 (mean+-SD)
Sex: 17 males, 0 females
Participant flow
Number of people randomly assigned: 34
Number excluded after randomization: 0 in each group
Number of persons followed and lost to follow-up in each group: 17 persons followed in each group, 0 persons lost to follow-up in each group
Number of patients who received the intended treatment: 17 in each group
Number used for analysis of primary outcome: 17 in each group
Adverse events
No adverse events were observed.
Outcome measures
The Chalder Physical Fatigue Scale was significantly improved in the lactobacillus group compared to the placebo group (p=0.049). Furthermore, the GHQ-28 total score was significantly improved in the lactobacillus group compared to the placebo group (p=0.005).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031608
