UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060564 |
|---|---|
| Receipt number | R000069271 |
| Scientific Title | Randomized single-blind counterbalanced crossover pilot trial comparing hydrogen-releasing bath salts (Vitalise Bath) versus warm-water control on oxidative stress (d-ROMs, BAP), thermoregulation, and muscle oxygenation after exercise |
| Date of disclosure of the study information | 2026/02/03 |
| Last modified on | 2026/02/03 14:16:43 |
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Basic information
Public title
Hydrogen-releasing bath salts for post-exercise recovery (temperature, muscle oxygenation, and oxidative stress): a single-blind crossover pilot study
Acronym
H2Bath Recovery Pilot
Scientific Title
Randomized single-blind counterbalanced crossover pilot trial comparing hydrogen-releasing bath salts (Vitalise Bath) versus warm-water control on oxidative stress (d-ROMs, BAP), thermoregulation, and muscle oxygenation after exercise
Scientific Title:Acronym
H2Bath Crossover Recovery Study
Region
| Japan |
Condition
Condition
Post-exercise fatigue and recovery (recovery with warm-water immersion)
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In healthy young men, whether warm-water immersion with hydrogen-releasing bath salts (Vitalise Bath) differs from warm-water immersion without bath salts (control) during post-exercise recovery, using a single-blind randomized counterbalanced crossover design. We will assess thermoregulation (deep muscle temperature and sublingual temperature), muscle oxygenation (NIRS), and oxidative stress/antioxidant capacity (d-ROMs and BAP). The washout period is 7 days.
Basic objectives2
Others
Basic objectives -Others
To evaluate efficacy of the bath salts on recovery facilitation based on the primary outcome (thermoregulatory recovery profile).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Deep muscle temperature of the quadriceps (vastus lateralis): recovery time-course (baseline pre-bath, during 20-min bath, and 20-min post-bath recovery)
Key secondary outcomes
Sublingual temperature: time-course (baseline pre-bath, during 20-min bath, and 20-min recovery)
Muscle oxygenation (NIRS, O2Hb): time-course (baseline, during bath, recovery)
d-ROMs: pre- and post-bath (pre/post)
BAP: pre- and post-bath (pre/post)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
hydrogen-releasing bath salts dissolved
Interventions/Control_2
warm water
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males aged from 20 to 29 years
Able to provide written informed consent
Able to attend both sessions (crossover)
Key exclusion criteria
History or current treatment of cardiovascular/respiratory/metabolic diseases
Acute illness/fever, skin disease, or contraindication to hot bathing (e.g., heat intolerance/syncope)
Deemed inappropriate by the investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Pengyu |
| Middle name | |
| Last name | Deng |
Organization
Venex Co., Inc.
Division name
Research and Development Group
Zip code
243-0018
Address
4-4-13, Naka-cho, Atuki-city, Kanagawa, Japan
TEL
0462009288
to@venex-j.co.jp
Public contact
Name of contact person
| 1st name | Pengyu |
| Middle name | |
| Last name | Deng |
Organization
Venex Co., Inc.
Division name
Research and Development Group
Zip code
243-0018
Address
4-4-13, Naka-cho, Atuki-city, Kanagawa, Japan
TEL
0462009288
Homepage URL
to@venex-j.co.jp
Sponsor or person
Institute
Pengyu Deng
Institute
Department
Personal name
Funding Source
Organization
Venex Co., Inc.
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
Committee of the Graduate School of Sports and Health of Juntendo University
Address
1-1, Hiragagakuenndai, Inzai city, Chiba, Japan
Tel
0476-98-1001
houu.tou@gmail.com
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 | 02 | Month | 03 | Day |
Related information
URL releasing protocol
https://doi.org/10.17605/OSF.IO/PYDT2
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.17605/OSF.IO/PYDT2
Number of participants that the trial has enrolled
6
Results
d-ROMs changed from 321.2(57.7) (pre) to 279.7(80.7) (post) in control and from 269.3(84.3) (pre) to 293.3(65.7)(post) in the hydrogen condition. BAP changed from 2984.0(1115) to 2860.7(978.4)(post) in control and from 3221.3(499.4)(pre) to 2725.3(881.3)(post) in the hydrogen condition. Deep muscle temperature showed significant main effects of condition and time without interaction, indicating different heating/cooling profiles between conditions.
Results date posted
| 2026 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Six healthy young adult males: age 22years, height 171.5cm, weight 65.3kg.
Participant flow
Six participants were enrolled. All participants completed both conditions (bath salts and warm-water control), and all (n=6) were included in the analysis. Sessions were separated by a 7-day washout.
Adverse events
No adverse events were observed.
Outcome measures
Primary outcomes: serum d-ROMs and serum BAP (pre- and post-bath).
Secondary outcomes: deep muscle and skin temperature (every 2 min), sublingual temperature, cutaneous blood flow (laser Doppler), and skeletal muscle NIRS indices (O2Hb/HHb/tHb; 30-s averages per time point).
Plan to share IPD
Yes (de-identified IPD will be available upon reasonable request)
IPD sharing Plan description
De-identified individual participant data (IPD) underlying the primary and secondary outcomes, intervention condition, time points, and required covariates, together with a data dictionary, will be shared after journal publication upon reasonable request for academic research purposes. Data will not be publicly posted. Access will require a research proposal (including an analysis plan) and, where applicable, confirmation of ethics approval. Sharing will be conditional on agreement to data-use terms (and a data use agreement if required). Data will be provided via a secure encrypted electronic transfer. Requests should be directed to the corresponding author.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 25 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069271
