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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027576
Receipt No. R000031608
Scientific Title Research on mental stress and physical exercise function
Date of disclosure of the study information 2017/08/01
Last modified on 2017/11/09

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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
Middle name
Last name Kazuhito Rokutan
Organization Tokushima University
Division name Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9004
Email rokutan@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensei Nishida
Organization Tokushima University
Division name Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9004
Homepage URL
Email knishida@tokushima-u.ac.jp

Sponsor
Institute Tokushima university
Institute
Department

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
Address
Tel
Email

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
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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
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
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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