UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033642 |
|---|---|
| Receipt number | 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 | 2019/08/06 14:04:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Womens University
Division name
Department of Food and Health Sciences, International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan
TEL
092-661-2411
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Seiha |
| Middle name | |
| Last name | Harada |
Organization
Fukuoka Womens University
Division name
General Affairs Management Group
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan
TEL
092-661-2411
Homepage URL
soumu5@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Womens University
Institute
Department
Personal name
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
Epidemiological Research Ethics Committee of Fukuoka Women's University
Address
1-1-1 Kasumigaoka, Higashi-ku, F ukuoka 813-8529, Japan
Tel
092-661-2411
soumu5@fwu.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
| 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
12
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
| 2019 | Year | 08 | Month | 06 | Day |
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
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
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 | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038360
