UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023550
Receipt No. R000024526
Scientific Title Basic research on the change in hydrogen gas concentrations in the expired air after intake of hydrogen-dissolved water and water containing indigestible sugars
Date of disclosure of the study information 2016/08/10
Last modified on 2016/08/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Basic research on the change in hydrogen gas concentrations in the expired air after intake of hydrogen-dissolved water and water containing indigestible sugars
Acronym Hydrogen gas concentrations in the expired air after intake of hydrogen-dissolved water and water containing indigestible sugars
Scientific Title Basic research on the change in hydrogen gas concentrations in the expired air after intake of hydrogen-dissolved water and water containing indigestible sugars
Scientific Title:Acronym Hydrogen gas concentrations in the expired air after intake of hydrogen-dissolved water and water containing indigestible sugars
Region
Japan

Condition
Condition Normal subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To determine the changes in the hydrogen gas production by the enterobacterial flora after administration of indigestible sugars by measuring the hydrogen gas concentrations in expired air.
2) To determine the expired-air hydrogen gas concentrations after intake of hydrogen-dissolved mineral water.
3) To determine whether the persons with higher expired-gas hydrogen gas concentration in daily life are likely to enhance hydrogen production after intake of indigestible sugars.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes expired-air hydrogen gas concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Prevention
Type of intervention
Food Other
Interventions/Control_1 Subjects were instructed to finish their dinner before 7 pm on the day before the experiment, and to consume only water, tea or coffee after 7 pm until the start of the experiment.
The subjects were given 300 mL of plain mineral water.
Expired air samples were collected every hour from 0900 hours to 2100 hours.
Interventions/Control_2 Subjects were instructed to finish their dinner before 7 pm on the day before the experiment, and to consume only water, tea or coffee after 7 pm until the start of the experiment.
The subjects were given 300 mL of water containing maltitol to drink. The amount of maltitol contained in the water was adjusted to 0.3 g/kg body weight..
Expired air samples were collected every hour from 0900 hours to 2100 hours.
Interventions/Control_3 Subjects were instructed to finish their dinner before 7 pm on the day before the experiment, and to consume only water, tea or coffee after 7 pm until the start of the experiment.
The subjects were given 300 mL of water containing fructooligosaccharides to drink. The amount of fructooligosaccharides contained in the water was adjusted to 0.3 g/kg body weight..
Expired air samples were collected every
Interventions/Control_4 Subjects were instructed to finish their dinner before 7 pm on the day before the experiment, and to consume only water, tea or coffee after 7 pm until the start of the experiment.
The subjects were given 300 mL of water containing raffinose to drink. The amount of raffinose contained in the water was adjusted to 0.3 g/kg body weight..
Expired air samples were collected every hour from 0900 hours to 2100 hours.
Interventions/Control_5 Subjects were instructed to finish their dinner before 7 pm on the day before the experiment, and to consume only water, tea or coffee after 7 pm until the start of the experiment.
The subjects were given 300 mL of hydrogen-dissolved water(1.5 ppm)
the expired air sampling frequency was every 10 min for 1h, then every hour until 1400 hours
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Normal subject
Key exclusion criteria The exclusion criteria were a history of smoking and history of intake of antibiotics within the previous month.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirosuke Kobayashi
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL +81-42-778-9711
Email hiro@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Kokubo
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL +81-42-778-9643
Homepage URL
Email kokubo@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
Organization
Division
Category of Funding Organization Self funding
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 北里大学(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 10 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
2015 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 31 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
2016 Year 08 Month 08 Day
Last modified on
2016 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.