UMIN-CTR Clinical Trial

Basic information
Public title	Effect of functional water intake on healthuey adults : a randomized, double-blind, placebo-controlled study
Acronym	Functional water clinical trial ; a randomized, double-blind, placebo-controlled study
Scientific Title	Effect of functional water intake on healthuey adults : a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym	Functional water clinical trial ; a randomized, double-blind, placebo-controlled study
Region	Japan

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

Objectives
Narrative objectives1	Effect of functional water intake on healthuey adults : a randomized, double-blind, placebo-controlled study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hepatic function(TP,ALB,AST,ALT,gamma-GTP) Renal function(Ureanitrogen,Creatine, Uric acid) Saliva Immunoglobulin A Saliva Cortisol POMS2 short virsion SRS-18(Stress Response Scale-18) CFS(Chalder Fatigue Scale) OSA sleep inventory MA version
Key secondary outcomes	Glucose,HbA1c TG,TC,HDL-C

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	To intake functional water 1L/day for 8 weeks.
Interventions/Control_2	To intake placebo water 1L/ day for 8 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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Persons who is generally judged as healthy (2) Persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria	(1) Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) Persons who have changed their habitats to take supplements within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) Persons who have been treated their illness or prevention in a clinic at their informed consent (5) Persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) Persons with the medical histories of alcoholism or drug dependence (7) Persons who might be developed allergic reaction to foods (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) Persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) Persons who will not be judged suitable to the participants by the investigator
Target sample size	31

Research contact person
Name of lead principal investigator	1st name Kuniyoshi Middle name Last name Shimizu
Organization	Graduate School of Kyushu University Faculty of Agriculture
Division name	Department of Agro-Environmental Sciences Laboratory of Systematic Forest and Forest Products Sciences
Zip code	819-0385
Address	744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL	092-802-4673
Email	shimizu@agr.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Kuniyoshi Middle name Last name Shimizu
Organization	Graduate School of Kyushu University Faculty of Agriculture
Division name	Department of Agro-Environmental Sciences Laboratory of Systematic Forest and Forest Products Scienc
Zip code	819-0385
Address	744 Motooka, Nishi-ku, Fukuoka, Fukuoka, JAPAN
TEL	092-802-4673
Homepage URL
Email	shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Kyushu University Faculty of Agriculture
Institute
Department

Funding Source
Organization	TAKAGI Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Faculty of Humanity-Oriented Science and Engineering,Kindai University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee,Faculty of Humanity-Oriented Science and Engineering, Kindai University
Address	11-6 Kayanomori,Iizuka city,fukuoka,JAPAN
Tel	0948-22-5655
Email	ohnuki@fuk.kindai.ac.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	2022 Year 03 Month 22 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	31
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	2020 Year 12 Month 18 Day
Date of IRB	2020 Year 03 Month 01 Day
Anticipated trial start date	2021 Year 01 Month 25 Day
Last follow-up date	2021 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 24 Day
Last modified on	2022 Year 07 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049221