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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023116
Receipt No. R000026629
Scientific Title Effects of hydrogen water on the body fat-reducing, anti-oxidant and anti-fatigue: a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2017/12/31
Last modified on 2017/11/17

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Basic information
Public title Effects of hydrogen water on the body fat-reducing, anti-oxidant and anti-fatigue: a randomized, double blind, placebo-controlled study
Acronym Effects of hydrogen water on the body fat-reducing, anti-oxidant and anti-fatigue
Scientific Title Effects of hydrogen water on the body fat-reducing, anti-oxidant and anti-fatigue: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiromi To
Organization Kenkoukazoku Co., Ltd
Division name None
Zip code
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
1st name
Middle name
Last name Yasushi Nakasone
Organization Kenkoukazoku Co., Ltd.
Division name Quality Management Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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