UMIN-CTR Clinical Trial

Basic information
Public title	Effects of 4-week Functional Water Intake
Acronym	Effects of 4-week Functional Water Intake
Scientific Title	Psychological, Physiological and Biochemical Effects of 4-week Functional Water Intake
Scientific Title:Acronym	Psychological, Physiological and Biochemical Effects of 4-week Functional Water Intake
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the psychological, physiological and biochemical effects of 4-week functional water intake
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the psychological, physiological, and biochemical indices before and after 4-week intake of a functional water.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) 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 4 weeks
Interventions/Control_2	Intake of the placebo drink twice a day for 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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Persons who are aged from 20 to 59 years and do not meet the exclusion criteria. 2. Persons who are full-time worker on the day shift. 3. 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 have current history of peptic ulcer. 4. Persons who are in treatment. 5. Persons who usually take in health foods and supplements. 6. Persons who have food allergy. 7. Persons who have vision disorder or auditory disorder. 8. Persons who are pregnant or breastfeed. 9. Persons who cannot drink an unsweetened soda or a cold drink. 10. Persons who have previous history of vasovagal syncope during or after blood sampling. 11. Persons who are now participating in other clinical trials or participated in other clinical trials within a month before obtaining his/her informed consent in this trial. 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	64

Research contact person
Name of lead principal investigator	1st name Kyosuke Middle name Last name Watanabe
Organization	RIKEN
Division name	Laboratory for Pathophysiological and Health Science
Zip code	6500047
Address	6-7-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL	078-569-8868
Email	kyosuke.watanabe@riken.jp

Public contact
Name of contact person	1st name Kyosuke Middle name Last name Watanabe
Organization	RIKEN
Division name	Laboratory for Pathophysiological and Health Science
Zip code	6500047
Address	6-7-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL	078-569-8868
Homepage URL
Email	kyosuke.watanabe@riken.jp

Sponsor
Institute	ASAHI SOFT DRINKS CO., LTD.
Institute
Department

Funding Source
Organization	ASAHI SOFT DRINKS 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	RIKEN
Address	2-2-3 Minatojima-minamimachi, Chuo-ku, Kob e, 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	2022 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
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	2021 Year 06 Month 01 Day
Date of IRB	2021 Year 06 Month 17 Day
Anticipated trial start date	2021 Year 07 Month 26 Day
Last follow-up date	2023 Year 03 Month 31 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 07 Month 20 Day
Last modified on	2022 Year 05 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051315