UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029062
Receipt number R000033221
Scientific Title Efficacy of drinking hydrogen water on exercise tolerance and fatigue accessed by placebo controlled double blinded examination.
Date of disclosure of the study information 2017/09/11
Last modified on 2017/09/08 17:16:04

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Basic information

Public title

Efficacy of drinking hydrogen water on exercise tolerance and fatigue accessed by placebo controlled double blinded examination.

Acronym

Efficacy of drinking hydrogen water on exercise tolerance and fatigue.

Scientific Title

Efficacy of drinking hydrogen water on exercise tolerance and fatigue accessed by placebo controlled double blinded examination.

Scientific Title:Acronym

Efficacy of drinking hydrogen water on exercise tolerance and fatigue.

Region

Japan


Condition

Condition

Health care for healthy adults with no illness

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate whether healthy adults improve exercise tolerance and/or reduce fatigue by drinking hydrogen water.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

After drinking 500 mL placebo or hydrogen water, maximum oxygen consumption and a conscious fatigue degree of volunteers are measured by bicycle-exercise with an ergometer. The maximum oxygen consumption is examined by gradually raising the load of the pedal, and monitoring a change of the heart beat pulse and normalized by age, body weight. The conscious fatigue degree is reported according to the Borg index and a visual analog scale (VAS).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

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

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Volunteers drink 500 mL placebo water to obtain background data.

Interventions/Control_2

After 2 weeks, half of them drink 500 mL of placebo and half drink hydrogen water to obtain data.

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy adults with no illness who dose not drink hydrogen water for most recent three months.

Key exclusion criteria

Just before examination, if body temperature or blood pressure exceeds 37 degree or 141 mmHg, we will exclude him from the subjects.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Mikami

Organization

Nippon Medical School

Division name

Department of Health and Sports Science

Zip code


Address

Department of Health and Sports Science, Nippon Medical School, 1-7-1 Kyounan-cho, Musashino, Tokyo 180-0023, Japan

TEL

0422-34-3451

Email

mikami@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshio Mikami

Organization

Nippon Medical School

Division name

Department of Health and Sports Science

Zip code


Address

Department of Health and Sports Science, Nippon Medical School, 1-7-1 Kyounan-cho, Musashino, Tokyo

TEL

0422-34-3451

Homepage URL


Email

mikami@nms.ac.jp


Sponsor or person

Institute

Department of Health and Sports Science, Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Hydrogen water consortium

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 09 Month 11 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

Preinitiation

Date of protocol fixation

2017 Year 09 Month 06 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 11 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 09 Month 08 Day

Last modified on

2017 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033221


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name