UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022382
Receipt number R000025795
Scientific Title Experiment for verification of the anti-fatigue effects of hydrogen-rich water in daily life: cross-over study.
Date of disclosure of the study information 2016/05/20
Last modified on 2016/08/10 16:11:31

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Basic information

Public title

Experiment for verification of the anti-fatigue effects of hydrogen-rich water in daily life: cross-over study.

Acronym

The anti-fatigue effects of hydrogen-rich water.

Scientific Title

Experiment for verification of the anti-fatigue effects of hydrogen-rich water in daily life: cross-over study.

Scientific Title:Acronym

The anti-fatigue effects of hydrogen-rich water.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of the anti-fatigue effects of hydrogen-rich water on subjective fatigue and autonomic nervous system in daily life.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in subjective fatigue, autonomic nervous function,
oxidation stress and antioxidant activity after 4 weeks.

Key secondary outcomes

Amount of activity
Cognitive function


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test water for 4 weeks. / Wash out for 4
weeks. / Ingestion of placebo water for 4 weeks.

Interventions/Control_2

Ingestion of placebo water for 4 weeks. / Wash out for 4
weeks. / Ingestion of test water for 4 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

20 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

1.Healthy persons who are aged from 20 to 49 years.
2.Persons who are not shift worker.

Key exclusion criteria

1.Pregnant women.
2.Persons who are in treatment.
3.Persons who have medical history of cardiovascular disease.
4.Persons who have medical history of nervous system disease such as unconsciousness, coma, and convulsion, etc.
5.Persons who have insomnia.
6.Persons who have food allergy.
7.Persons who are heavy user of alcohol.
8.Persons who are judged not suitable to participate in this trial by investigators.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuyoshi Watanabe

Organization

Osaka City University

Division name

Center for Health Science Innovation

Zip code


Address

9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.

TEL

06-6485-0288

Email

chsi-b@ado.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kei Mizuno

Organization

Osaka City University

Division name

Center for Health Science Innovation

Zip code


Address

9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.

TEL

06-6485-0288

Homepage URL


Email

chsi-b@ado.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Center for Health Science Innovation

Institute

Department

Personal name



Funding Source

Organization

Melodian Co.,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

大阪市立大学健康科学イノベーションセンター


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 20 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

Completed

Date of protocol fixation

2014 Year 06 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 12 Day

Last follow-up date

2014 Year 12 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 20 Day

Last modified on

2016 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025795


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name