UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of hydrogen water on the body fat-reducing, anti-oxidant and anti-fatigue: a randomized, double blind, placebo-controlled study
Title of the study (Brief title)	Effects of hydrogen water on the body fat-reducing, anti-oxidant and anti-fatigue
Region	Japan

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

Objectives
Narrative objectives1	Investigation of the body fat-reducing, anti-oxidant and anti-fatigue effects of hydrogen water.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VFA, 8, 12 weeks after investigation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Prevention
Type of intervention	Food
Interventions/Control_1	hydrogen water 500 mL per day for 12 weeks
Interventions/Control_2	water 500 mL per day for 12 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Subjects who are age from 20 to 64. 2)BMI<30 kg/m2 3)Subjects who are selected VFA and d-ROMs, BAP
Key exclusion criteria	1) Subjects who have the habit of taking test food. 2) Under losing body weight 3) Subjects who have the habit of taking healthcare products. 4) Patients who have serious disease or subjects who have serious disease history. 5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination. 6) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. 7) Subjects who are participated in other clinical studies. 8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. 9) Subjects who are judged unfit to enroll in this trial by the investigator.
Target sample size	62

Research contact person
Name of lead principal investigator	Hiromi To
Organization	Kenkoukazoku Co., Ltd
Division name	None
Address	10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL	099-223-5211
Email	yasushi.nakasone@kenkoukazoku.co.jp

Public contact
Name of contact person	Yasushi Nakasone
Organization	Kenkoukazoku Co., Ltd.
Division name	Quality Management Division
Address	10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL	099-223-5211
Homepage URL
Email	yasushi.nakasone@kenkoukazoku.co.jp

Sponsor
Institute	TTC Co.,Ltd
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 23 Day
Anticipated trial start date	2016 Year 07 Month 13 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	2016 Year 07 Month 11 Day
Last modified on	2017 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026629