UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053237 |
|---|---|
| Receipt number | R000060225 |
| Scientific Title | The effect of hydrogen-rich jelly on sleep quality in healthy subjects: A randomized, double-blind, placebo-controlled, parallel study |
| Date of disclosure of the study information | 2023/12/27 |
| Last modified on | 2024/03/27 09:48:46 |
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Basic information
Public title
The effect of hydrogen-rich jelly on sleep quality in healthy subjects
Acronym
The effect of hydrogen-rich jelly on sleep quality in healthy subjects
Scientific Title
The effect of hydrogen-rich jelly on sleep quality in healthy subjects: A randomized, double-blind, placebo-controlled, parallel study
Scientific Title:Acronym
The effect of hydrogen-rich jelly on sleep quality in healthy subjects: A randomized, double-blind, placebo-controlled, parallel study
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of hydrogen-rich jelly on sleep quality
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
8-week change in OSA-Sleep Inventory MA Version
Key secondary outcomes
8-week changes in the following: Visual Analogue Scale (Sleep quality, Mental stress, Physical fatigue), Pittsburg Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI), Stool frequency, Gut microbiome, Oxidative stress and anti-oxidant markers (Urinary 8-hydroxy-2'-deoxyguanosine, Urinary isoprostanes, Serum oxidized/total coenzyme Q10 ratio, Serum LPO, Serum Fe, Serum Cu, Serum cholesterol, Serum triglyceride, Serum total antioxidant status, Serum uric acid, Serum vitamin C, Serum folic acid, Serum vitamin B12, Serum lutein and zeaxanthin, Serum beta-cryptoxanthin, Serum lycopene, Serum beta-carotene, Serum vitamin A, Serum alpha-tocopherol, Serum delta-tocopherol, Serum beta-gamma tocopherol, Serum alpha-tocopherol/cholesterol ratio, Serum ubiquinol)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take 10 g of jelly containing 30 ppm of hydrogen three times per day for 8 weeks.
Interventions/Control_2
Subjects take 10 g of jelly containing 30 ppm of air three times per day for 8 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females who constantly feel unsatisfaction with sleep quality
2) The average standardized score of five distinct factors in OSA-MA is under 45
Key exclusion criteria
1) Under chronic diseases
2) Taking medicines or dietary supplements that may affect the trial
3) Participation in any clinical trial within three months of the commencement of the trial
4) In pregnancy or nursing a child
5) Judged as ineligible by the investigators
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-1909
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-1909
Homepage URL
healthy-life@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Shinryo Corporation
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.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
| 2023 | Year | 12 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 27 | 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
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060225
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
