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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033102
Receipt No. R000037749
Official scientific title of the study Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota.
Date of disclosure of the study information 2018/06/29
Last modified on 2018/06/25

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Basic information
Official scientific title of the study Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota.
Title of the study (Brief title) Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota.
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Gastroenterology Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the gut dysbiosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To improve the gut dysbiosis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 28 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 50

Research contact person
Name of lead principal investigator Toru Ishibashi
Organization Huis Ten Bosch Satellite H2 Clinic Hakata
Division name Department of rheumatology and gastroenterology
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 Toru Ishibashi
Organization Huis Ten Bosch Satellite H2 Clinic Hakata
Division name Department of rheumatology and gastroenterology
Address 2-1 Gion, Hakata-ku, Fukuoka 812-0038, Japan
TEL +81-92-282-5005
Homepage URL
Email info@h2-clinic.jp

Sponsor
Institute Huis Ten Bosch Satellite H2 Clinic Hakata
Ecomo International Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ecomo International Co., Ltd.
Name of secondary funder(s)

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 06 Month 29 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 22 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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