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

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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

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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name