UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059035 |
|---|---|
| Receipt number | R000067474 |
| Scientific Title | A study on the effects of long-term hydrogen jelly intake on health |
| Date of disclosure of the study information | 2025/09/09 |
| Last modified on | 2025/09/09 14:43:41 |
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Basic information
Public title
A study on the effects of long-term hydrogen jelly intake on health
Acronym
A study on the effects of long-term hydrogen jelly intake on health
Scientific Title
A study on the effects of long-term hydrogen jelly intake on health
Scientific Title:Acronym
A study on the effects of long-term hydrogen jelly intake on health
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of long-term intake of hydrogen jelly on improving biological rhythms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in heart rate variability data before and after intervention (after 9 weeks)
Key secondary outcomes
Changes in heart rate variability data before and after intervention (after 5 weeks), Patient Health Questionnaire-9 (PHQ-9), Pittsburgh Sleep Quality Index, new version of the STAI State-Trait Anxiety Inventory, DLQI questionnaire, SKINDEX29 questionnaire, VOCs at rest, stratum corneum moisture content, and transepidermal water loss before and after intervention (after 5 and 9 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one bottle of hydrogen jelly per day for two months.
Interventions/Control_2
Take three bottles of hydrogen jelly per day for two months.
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 between the ages of 20 and 60.
2. Individuals who drink alcohol regularly (at least three times a week, 10g per session (equivalent to 350ml of beer)).
3. Individuals with mild skin symptoms (a score of 2 or higher on the DLQI questionnaire).
4. Individuals who fully understand the purpose of this study and agree to participate in it.
Key exclusion criteria
1. Individuals who the principal investigator or co-investigator deems inappropriate for this study.
2. Individuals diagnosed with lifestyle-related disease #2 at the time of participation and receiving oral medication.
3. Individuals receiving oral medication for cerebrovascular, cardiovascular, pulmonary, digestive, renal, or autoimmune diseases at the time of participation.
4. Individuals who have used hydrogen products within the past week at the time of consent.
5. Individuals who plan to use hydrogen products after consenting until the end of the study.
6. Individuals with dementia or psychiatric disorders who are unable to understand the significance of this study.
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
160-0016
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
Shinryo Corporation
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
| 2025 | Year | 09 | Month | 09 | 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
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067474
