UMIN-CTR Clinical Trial

Basic information
Public title	Effects of prolonged intake of functional water in daily life
Acronym	Effects of functional water
Scientific Title	Effects of prolonged intake of functional water in daily life
Scientific Title:Acronym	Effects of prolonged intake of functional water in daily life
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effects of prolonged intake of functional water on health promotion in daily life
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of psychophysiological and biochemical indices with or without functional water intake in daily life
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	Intake of the test drink twice a day for 16 weeks
Interventions/Control_2	Intake of the placebo drink twice a day for 16 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	35 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Persons who are aged from 35 to 65 years and do not meet the exclusion criteria. 2. Persons who can give written informed consents.
Key exclusion criteria	1. Persons who have previous history such as neurological disorder, nervous system disorder, cardiovascular disease, and other serious disease. 2. Persons who have previous history of nervous system disease such as unconsciousness, coma, convulsion, etc. 3. Persons who are in treatment. 4. Persons who have food allergy. 5. Persons who have vision disorder or auditory disorder. 6. Persons who are pregnant or breastfeed. 7. Persons who have previous history of vasovagal syncope during or after blood sampling. 8. Persons who are currently smoking. 9. Persons who are continuously intake electrolyzed hydrogen water or hydrogen water within two months before obtaining his/her informed consent in this trial. 10. Persons who are now participating in other clinical trials or participated in other clinical trials within two months before obtaining his/her informed consent in this trial. 11. Persons who cannot set a water purifier at home. 12. Persons who cannot follow the instructions for COVID-19 infection prevention. 13. Persons who are judged not suitable to participate in this trial by investigators.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yasuyoshi Middle name Last name Watanabe
Organization	RIKEN
Division name	Laboratory for Pathophysiological and Health Science
Zip code	650-0047
Address	6-7-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL	078-304-7101
Email	yywata@riken.jp

Public contact
Name of contact person	1st name Kei Middle name Last name Mizuno
Organization	RIKEN
Division name	Laboratory for Pathophysiological and Health Science
Zip code	650-0047
Address	6-7-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL	078-569-8868
Homepage URL
Email	keimizuno@riken.jp

Sponsor
Institute	RIKEN
Institute
Department

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

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

IRB Contact (For public release)
Organization	Ethics Committee of RIKEN
Address	2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
Tel	078-306-3036
Email	kobe-ankan@cdb.riken.jp

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	2024 Year 03 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	51
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	No longer recruiting
Date of protocol fixation	2022 Year 04 Month 12 Day
Date of IRB	2022 Year 04 Month 15 Day
Anticipated trial start date	2022 Year 04 Month 22 Day
Last follow-up date	2022 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 12 Month 13 Day
Last modified on	2022 Year 12 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056676