UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055168 |
|---|---|
| Receipt number | R000063016 |
| Scientific Title | Examining the positive effect of drinking hydrogen water on biological rhythms |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2025/02/17 21:20:48 |
* 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
Examining the positive effect of drinking hydrogen water on biological rhythms
Acronym
Examining the positive effect of drinking hydrogen water on biological rhythms
Scientific Title
Examining the positive effect of drinking hydrogen water on biological rhythms
Scientific Title:Acronym
Examining the positive effect of drinking hydrogen water on biological rhythms
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the positive effect of drinking hydrogen water on biological rhythms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in heart rate variability after intervention.
Key secondary outcomes
Changes in Patient Health Questionnaire-9 (PHQ-9), Pittsburgh Sleep Quality Index, STAI State-Trait Anxiety Inventory (STAI), number of steps, activity level, sleep data, VOC at rest, and VOC after exercise load after the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Drinking hydrogen water on daily life.
Interventions/Control_2
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 20-60 years
2. Those who have exercise habits or not, but who verbally respond that they can continue moderate-intensity exercise (exercise at 75-80% of maximum heart rate) for 20 minutes
3. Those who drink alcohol on a daily basis
4. Those with mild sleep disorders (score 6 or higher on the Pittsburgh Sleep Quality Index)
5. Those who fully understand the purpose of this study and agree to participate in it
Key exclusion criteria
1. Those who the principal investigator or co-investigator judges to be unsuitable for this study
2. Those with comorbid conditions that prevent exercise
3. Those who have been instructed by a doctor to limit exercise
4. Those who have difficulty exercising on a daily basis due to chronic back pain, knee pain, etc.
5. Those who are unable to understand the significance of this study due to depression or other mental illnesses
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
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
Other
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
03-5363-3503
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
| 2024 | Year | 08 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063016
