UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063101 |
|---|---|
| Receipt number | R000072239 |
| Scientific Title | Effects of hydrogen-rich jelly intake on the human body: a randomized controlled trial |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/29 18:25:55 |
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Basic information
Public title
Effects of hydrogen-rich jelly intake on the human body: a randomized controlled trial
Acronym
Effects of hydrogen-rich jelly intake on the human body: a randomized controlled trial
Scientific Title
Effects of hydrogen-rich jelly intake on the human body: a randomized controlled trial
Scientific Title:Acronym
Effects of hydrogen-rich jelly intake on the human body
Region
| Japan |
Condition
Condition
healthy participants with skin symptoms
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effects of hydrogen-rich jelly intake on the human body, namely skin resilience, sleep quality and psychological status.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group difference in the SKINDEX-29 overall score at 9 weeks after the start of intake, adjusted for the baseline value by analysis of covariance.
Key secondary outcomes
1. Between-group difference in the SKINDEX-29 overall score at 5 weeks after
the start of intake, adjusted for the baseline (pre-intervention) value.
2. Between-group differences in the adjusted change at 5 and 9 weeks after the
start of intake in the following variables:
- Patient Health Questionnaire-9 (PHQ-9)
- State-Trait Anxiety Inventory (STAI), new Japanese version
- Dermatology Life Quality Index (DLQI) questionnaire
- Pittsburgh Sleep Quality Index (PSQI)
- Heart rate variability data
- Stratum corneum hydration and transepidermal water loss
- 24-hour ambulatory blood pressure
- Peripheral oxygen saturation during sleep
- Sleep score obtained from a Fitbit device during sleep (score, rapid eye
movement sleep duration, non-rapid eye movement sleep duration)
- Volatile organic compounds (VOCs) in exhaled breath
Exploratory outcomes:
- Between-group differences in the adjusted change at 5 and 9 weeks after the
start of intake in volatile organic compounds emitted from the skin
- Identification of factors contributing to improvement in the parameters of
the primary and secondary outcome measures
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
| Food |
Interventions/Control_1
Participants ingest three pouches per day of hydrogen-rich jelly
(High-Concentration Hydrogen Jelly; dissolved hydrogen concentration of 30 ppm
or higher) for 9 weeks (plus or minus 1 week). In principle the three pouches
are taken around the three daily meals; if a dose is missed, participants are
instructed to take all three pouches within the same day. Intake is recorded
daily by the participant on the study record form and reported at each visit.
Interventions/Control_2
Participants ingest three pouches per day of non-hydrogen jelly (jelly that
does not contain hydrogen) for 9 weeks (plus or minus 1 week), under the same
instructions as the hydrogen jelly group. The non-hydrogen jelly is
manufactured at the same plant as the hydrogen jelly, is identical in all
components other than hydrogen, is identical in colour and taste, and is
packaged in the same aluminium pouch.
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 adults aged 20 to 60 years. "Healthy" is defined as having no health
disorder identified at a health check-up and taking no regular oral medication.
For this study, participants who take two or fewer oral drugs for allergic
disease, orthopaedic disease, autonomic dysfunction, sleep disorder or dental
disease, and participants who take dietary supplements, are also regarded as
healthy.
2. Presence of skin symptoms, defined as a Dermatology Life Quality Index
(DLQI) score of 3 or more.
3. Able to fully understand the purpose of the study and to provide informed
consent to participate.
Key exclusion criteria
1. Judged inappropriate for the study by the principal investigator or a
co-investigator.
2. Diagnosed with a lifestyle-related disease and receiving oral drug treatment
at the time of participation. Lifestyle-related diseases are defined according
to the Japan Association for the Prevention of Lifestyle-related Diseases as
hypertension, dyslipidaemia, type 2 diabetes mellitus, chronic kidney disease,
hyperuricaemia or gout, chronic obstructive pulmonary disease, and cancer.
3. Receiving oral drug treatment for cerebrovascular disease, cardiovascular
disease, pulmonary disease, gastrointestinal disease, renal disease or
autoimmune disease at the time of participation.
4. Use of any hydrogen-containing product within 1 week before obtaining
informed consent.
5. Planning to use any hydrogen-containing product between obtaining informed
consent and the end of the study.
6. Not agreeing to refrain from starting or changing any drug or dietary
supplement for skin symptoms after obtaining informed consent.
7. Unable to understand the significance of the study because of dementia or a
psychiatric disorder.
Target sample size
32
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
09091066192
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
09091066192
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
keio University
Institute
Department
Personal name
Funding Source
Organization
Shinryo 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 | 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
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 | 09 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 01 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072239
