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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033642
Receipt No. R000038360
Scientific Title The effect of soy milk on suppression of exercise fatigue and visual stress
Date of disclosure of the study information 2018/08/08
Last modified on 2019/02/05

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Basic information
Public title The effect of soy milk on suppression of exercise fatigue and visual stress
Acronym The effect of soy milk on suppression of fatigue and stress
Scientific Title The effect of soy milk on suppression of exercise fatigue and visual stress
Scientific Title:Acronym The effect of soy milk on suppression of fatigue and stress
Region
Japan

Condition
Condition healthy male adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate the effect of soy milk on suppression of exercise fatigue and reduction of visual stress due to virtual reality.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amylase, cortisol and chromogranin A in saliva
3-methylhistidine in urine
Key secondary outcomes mental health status evaluated by questionnaire (POMS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily consumption of soy milk 200ml during 10 days
Interventions/Control_2 No treatment
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
30 years-old >
Gender Male
Key inclusion criteria Healthy men over 18 years old who have no problem for exercise loading
Key exclusion criteria Those who has problem for exercise loading
Target sample size 12

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masaonri Ohta
Organization Fukuoka Womens University
Division name Department of Food and Health Sciences, International College of Arts and Sciences
Zip code
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan
TEL 092-661-2411
Email m-ohta@fwu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Koga
Organization Fukuoka Womens University
Division name General Affairs Management Group
Zip code
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan
TEL 092-661-2411
Homepage URL
Email keiei@fwu.ac.jp

Sponsor
Institute Fukuoka Womens University
Institute
Department

Funding Source
Organization Kyushu Institute of Technology
Organization
Division
Category of Funding Organization Other
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
2018 Year 08 Month 08 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
In the visual stress, the levels of salivary amylase was significantly increased in the control group (without ingestion) (p<0.05), but the increase was suppressed in the soymilk group, and the levels of salivary chromogranin A was significantly decreased in both groups (p<0.05, respectively).
In the exercise stress, the levels of salivary chromogranin A significantly decreased in the soymilk group (p<0.05), but did not change in the control group (without ingestion).
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
2018 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2018 Year 10 Month 05 Day
Date of closure to data entry
2018 Year 10 Month 20 Day
Date trial data considered complete
2018 Year 10 Month 20 Day
Date analysis concluded
2018 Year 11 Month 15 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038360

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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