Healthy volunteers
Conditions
Interventions
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy subjects aged from 30 to 60 years (bounds included) 2) Subject whose serum d-ROMs level between 301 U.CARR to 400 U.CARR (bounds included) 3) Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subject having the chronic fatigue syndrome (CFS), or subject deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator 3) Subject who takes regularly medicine or quasi-drugs which having the efficacy on recovery of fatigue or nutrition in cases of physical fatigue 4) Subject who regularly takes hydrogen water 5) Subject having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 6) Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 7) Female subject who is pregnant or lactating, or intending to become pregnant during the study 8) Subject deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Advanced trail making test (ATMT) , Chalder fatigue scale, autonomic nervous system function(spectrum analysis of a-a intervals on accelerated plethysmography), d-ROMs, BAP, OSI, hs-CRP, ox-LDL, cortisol, urinary 8-isoprostane, urinary 8-OHdG | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. Representative Director
Outcome results
None listed