UMIN ID: UMIN000055516
Registered date:17/09/2024
The effect of hydrogen-rich jelly on sleep quality in healthy subjects, part 2
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy |
| Date of first enrollment | 2024/09/17 |
| Target sample size | 44 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Subjects take 10 g of jelly containing 30 ppm of hydrogen thrice daily for 4 weeks. Subjects take 10 g of jelly containing 30 ppm of air thrice daily for 4 weeks. |
Outcome(s)
| Primary Outcome | 4-week changes in electroencephalographic sleep profiles |
|---|---|
| Secondary Outcome | 4-week changes in the following: Urinary 6-sulfatoxymelatonin, OSA-MA, Visual Analogue Scale (Sleep quality, Mental stress, Physical fatigue), Pittsburg Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI), Stool frequency |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Hiroshima University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Shinryo Corporation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Fumiko Higashikawa |
| Address | Kasumi 1-2-3, Minami-ku, Hiroshima Japan 734-8551 |
| Telephone | 082-257-1909 |
| healthy-life@hiroshima-u.ac.jp | |
| Affiliation | Hiroshima University Hospital Medical Center for Translational and Clinical Research |
| scientific contact | |
| Name | Fumiko Higashikawa |
| Address | Kasumi 1-2-3, Minami-ku, Hiroshima Japan |
| Telephone | 082-257-1909 |
| fumiko@hiroshima-u.ac.jp | |
| Affiliation | Hiroshima University Hospital Medical Center for Translational and Clinical Research |