UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032510
Receipt number R000037078
Scientific Title Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the EndPAT test
Date of disclosure of the study information 2018/05/10
Last modified on 2018/05/09 16:39:13

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Basic information

Public title

Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the EndPAT test

Acronym

An examination to observe the effects of the water containing 7ppm molecular hydrogen on the EndPAT test

Scientific Title

Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the EndPAT test

Scientific Title:Acronym

An examination to observe the effects of the water containing 7ppm molecular hydrogen on the EndPAT test

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To improve the peripheral endothelial function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement of Reactive hyperemia index(RHI)

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


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 the water containing 7ppm molecular hydrogen for 14 days/Daily consumption of the placebo water for 14 days.
In detail, the healthy volunteers were informed individually about the significance of the study and the instruments of intended measurement. These volunteers enrolled in this study after providing their written informed consent. The subjects were randomly divided into two groups: a high H2 group and a placebo group. All the subjects were asked to fast, and avoid drinking caffeinated drinks or ingesting sugar for 6 hours before the test. Using the EndPad2000 System (Itamar Medical Inc.), we measured the baseline RHI using endothelium-dependent digital pulse amplitude testing (EndoPAT). Next, the subjects drank 500 ml of the placebo water or the high H2 water (continuing 7ppm H2) within 10 min, and after resting for 1 h the RHI was measured again. On the second day, 24 h after the first ingestion of placebo or high H2 water and before the second ingestion, the RHI was measured. After the measurements were obtained, they took a second drink, and the day after, they drank the placebo or the high H2 water once each day until the day before the last measurements at 14 days. In total, they drank the high H2 water or placebo 14 times.

Interventions/Control_2

The placebo water was prepared by filling up a PET bottle containing water with molecular nitrogen (N2) gas under 0.8 MPa to make the placebo bottles as firm as the bottles with the high H2 water containing 7ppm H2.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy volunteers

Key exclusion criteria

All of the subjects took medications or dietary supplements or received medical treatments within 6 months before this study was performed.

Target sample size

68


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Ishibashi

Organization

Huis Ten Bosch Satellite H2 Clinic Hakata
Anicom Speciality Medical Institute

Division name

Department of rheumatology

Zip code


Address

2-1 Gion, Hakata-ku, Fukuoka 812-0038, Japan

TEL

+81-92-282-5005

Email

tishibashi@h2-lab.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Ishibashi

Organization

Huis Ten Bosch Satellite H2 Clinic Hakata

Division name

Department of rheumatology

Zip code


Address

2-1 Gion, Hakata-ku, Fukuoka 812-0038, Japan

TEL

+81-92-282-5005

Homepage URL


Email

info@h2-clinic.jp


Sponsor or person

Institute

Huis Ten Bosch Satellite H2 Clinic Hakata
Anicom Speciality Medical Institute

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Anicom Speciality Medical Institute

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

Huis Ten Bosch Satellite H2 Clinic Hakata
Anicom Speciality Medical Institute


Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2015 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 10 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

2018 Year 05 Month 08 Day

Last modified on

2018 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name