Unique ID issued by UMIN | UMIN000027700 |
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Receipt number | R000031724 |
Scientific Title | A clinical study to evaluate the anti-fatigue effect of hydrogen water |
Date of disclosure of the study information | 2018/11/30 |
Last modified on | 2018/12/27 17:43:08 |
A clinical study to evaluate the anti-fatigue effect of hydrogen water
The anti-fatigue effect of hydrogen water
A clinical study to evaluate the anti-fatigue effect of hydrogen water
The anti-fatigue effect of hydrogen water
Japan |
Healthy volunteers
Not applicable | Adult |
Others
NO
To investigate the anti-fatigue effect of hydrogen water: a randomized, double-blind, placebo-controlled, crossover study
Efficacy
Visual analogue scale (VAS)
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
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake of Test food (4 weeks) -> Washout (4 weeks) -> Intake of Placebo (4 weeks)
Intake of Placebo (4 weeks) -> Washout (4 weeks) -> Intake of Test food (4 weeks)
30 | years-old | <= |
60 | years-old | >= |
Male and Female
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
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
20
1st name | |
Middle name | |
Last name | Osami Kajimoto |
Osaka City University Graduate School of Medicine
Department of Medical Science on Fatigue
1-4-3 Asahi-machi, Abeno-ku, Osaka
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Tomohiro Sugino |
Soiken Inc.
Representative Director
Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc.
Melodian Co., Ltd.
Profit organization
NO
医療法人弘正会ふくだ内科クリニック
2018 | Year | 11 | Month | 30 | Day |
Unpublished
Completed
2017 | Year | 04 | Month | 15 | Day |
2017 | Year | 06 | Month | 10 | Day |
2017 | Year | 06 | Month | 09 | Day |
2018 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031724
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