UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Basic research on the change in hydrogen gas concentrations in the expired air after intake of hydrogen-dissolved water and water containing indigestible sugars
Title of the study (Brief title)	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	Hirosuke Kobayashi
Organization	Kitasato University
Division name	School of Allied Health Sciences
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	Kenichi Kokubo
Organization	Kitasato University
Division name	School of Allied Health Sciences
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 11 Month 21 Day
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

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Publication of results	Unpublished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