UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study to evaluate the anti-fatigue effect of hydrogen water
Title of the study (Brief title)	The anti-fatigue effect of hydrogen water
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the anti-fatigue effect of hydrogen water: a randomized, double-blind, placebo-controlled, crossover study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analogue scale (VAS)
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of Test food (4 weeks) -> Washout (4 weeks) -> Intake of Placebo (4 weeks)
Interventions/Control_2	Intake of Placebo (4 weeks) -> Washout (4 weeks) -> Intake of Test food (4 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	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	Osami Kajimoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Medical Science on Fatigue
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	Representative Director
Address	Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Melodian Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	医療法人弘正会ふくだ内科クリニック

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 15 Day
Anticipated trial start date	2017 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 09 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031724