UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023550 |
|---|---|
| Receipt number | 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 19:50:32 |
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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
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
kokubo@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024526
