UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062137 |
|---|---|
| Receipt number | R000071104 |
| Scientific Title | An Investigation into the Effects of Hydrogen-Enriched Water Consumption on Circadian Rhythms - A Randomised Controlled Pilot Trial - |
| Date of disclosure of the study information | 2026/07/04 |
| Last modified on | 2026/07/03 22:44:10 |
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Basic information
Public title
An Investigation into the Effects of Hydrogen-Enriched Water Consumption on Circadian Rhythms - A Randomised Controlled Pilot Trial -
Acronym
An Investigation into the Effects of Hydrogen-Enriched Water Consumption on Circadian Rhythms - A Randomised Controlled Pilot Trial -
Scientific Title
An Investigation into the Effects of Hydrogen-Enriched Water Consumption on Circadian Rhythms - A Randomised Controlled Pilot Trial -
Scientific Title:Acronym
An Investigation into the Effects of Hydrogen-Enriched Water Consumption on Circadian Rhythms - A Randomised Controlled Pilot Trial -
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to investigate the effects of drinking hydrogen-rich water on improving circadian rhythms in obese individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Consumption of hydrogen-rich water: 3 bottles of 245 ml each per day; intake period: 5 weeks
Interventions/Control_2
Consumption of non-hydrogen-rich water (drinking water that does not contain hydrogen): 3 bottles of 245 ml each per day; intake period: 5 weeks
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals aged between 20 and 60 with a BMI of 25 or above
2. Individuals with a slight decline in sleep quality (a score of 6 or above on the Pittsburgh Sleep Quality Index)
3. Individuals who fully understand the purpose of this trial and have consented to participate in it
Key exclusion criteria
1. Individuals deemed unsuitable for this trial by the principal investigator or co-investigators
2. Individuals who have used a hydrogen product within one week of giving their consent
3. Individuals who intend to use a hydrogen product after giving their consent and until the end of the study
4. Individuals with dementia or a mental disorder who are unable to understand the significance of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Katsumata |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
0333531211
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | YOSHINORI |
| Middle name | |
| Last name | KATSUMATA |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
0333531211
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio university
Institute
Department
Personal name
Funding Source
Organization
Itoen Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel
0333531211
med-rinri-jimu@adst.keio.ac.jp
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
| 2026 | Year | 07 | Month | 04 | 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
| 2026 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 03 | Day |
Last modified on
| 2026 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071104
