UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005779 |
|---|---|
| Receipt number | R000006836 |
| Scientific Title | Studies on in vivo effects of drinking a water product dissolving hydrogen gas as an in vitro antioxidant additive. |
| Date of disclosure of the study information | 2011/09/30 |
| Last modified on | 2011/10/17 11:57:34 |
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Basic information
Public title
Studies on in vivo effects of drinking a water product dissolving hydrogen gas as an in vitro antioxidant additive.
Acronym
Effects of drinking hydrogen gas-dissolving water
Scientific Title
Studies on in vivo effects of drinking a water product dissolving hydrogen gas as an in vitro antioxidant additive.
Scientific Title:Acronym
Effects of drinking hydrogen gas-dissolving water
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of reduction in oxidative stress in subjects who ingested a water product dissolving hydrogen gas as an antioxidant additive.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
the levels of serum LPO and urine 8-OHdG in subjects immediately before and after 1-week drinking period for 500ml per day of tap water with or without dissolved hydrogen gas at 0.34mg/l and 1-week before and after the drinking period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants 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
Ingestion of 500ml per day of hydrogen gas-dissolving water for 1 week
Interventions/Control_2
Ingestion of 500ml per day of control water without hydrogen gas for 1 week
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
| 21 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy students
Key exclusion criteria
persons with hepatic or renal dysfunction and females females in menstruation period
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hiraoka |
Organization
Kyorin University
Division name
Faculty of Health Sciences
Zip code
Address
476 Miyashita-cho, hachiojishi, Tokyo, Japan
TEL
042-691-0011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Hiraoka |
Organization
Faculty of Health Sciences, Kyorin University
Division name
Laboratory of Cytogenetics
Zip code
Address
476 Miyashita-cho, Hachioji-shi, Tokyo 192-8508, Japan
TEL
042-691-0011
Homepage URL
hiraokaa@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Faculty of Health Sciences, Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 30 | 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
No significant difference in the levels of oxidative stress markers in serum and urine between subjects ingested hydrogen gas-dissolving water and control water
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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 14 | Day |
Last modified on
| 2011 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006836
