UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053818 |
|---|---|
| Receipt number | R000061421 |
| Scientific Title | Effects of hydrogen jelly supplementation on biological responses at rest and during exercise. |
| Date of disclosure of the study information | 2024/03/11 |
| Last modified on | 2024/03/12 14:06:13 |
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Basic information
Public title
Effects of hydrogen jelly supplementation on biological responses at rest and during exercise.
Acronym
Effects of hydrogen jelly supplementation on biological responses at rest and during exercise.
Scientific Title
Effects of hydrogen jelly supplementation on biological responses at rest and during exercise.
Scientific Title:Acronym
Effects of hydrogen jelly supplementation on biological responses at rest and during exercise.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a good effects of hydrogen jelly supplementation on biological responses at rest and during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in heart rate variability data associated with hydrogen jelly supplementation
Key secondary outcomes
1,Changes in heart rate, oxygen intake, carbon dioxide output, blood lactate level, and subjective exercise intensity during constant load exercise associated with hydrogen jelly
2,Change in heart rate at the end of exercise compared to 10 minutes after starting associated with hydrogen jelly
3,Heart rate variability after exercise associated with hydrogen jelly
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Hydrogen jelly supplementation
Interventions/Control_2
Non-hydrogen jelly supplementation
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Healthy subjects between 18 and 60 years old
2.Subjects who have verbally answered that they are able to continue moderate-intensity exercise for 30 minutes, regardless of whether they have a habit of exercising or not.
Key exclusion criteria
1.Subjects who are judged by the research director or co-partner to be unsuitable for this research.
2.Subjects who are unable to exercise sufficiently due to injury or disability.
3.Subjects who take medication on a daily life
4.Subjects who are unable to understand the significance of this study due to dementia or mental illness.
Target sample size
50
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 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 | 03 | Month | 11 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2026 | 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 | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061421
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
