UMIN-CTR Clinical Trial

Basic information
Public title	The effects of natural reduced water on body composition and cognitive function in older adults
Acronym	The effects of natural reduced water on body composition and cognitive function in older adults
Scientific Title	The effects of natural reduced water on body composition and cognitive function in older adults
Scientific Title:Acronym	The effects of natural reduced water on body composition and cognitive function in older adults
Region	Japan

Condition
Condition	body composition/cognitive function/psychological function
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of natural reduced water on body composition and cognitive function in old adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*cognitive function(Executive function, short-term memory, attention function) *body composition(body water content, body fat percentage, muscle mass) *psychological function(subjective well-being, stress level, anxiety level) *timing of evaluation:6 months or 12 months after the start of the intervention
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	Drink 1L of natural reduced water daily for 6 months
Interventions/Control_2	Drink 1L of tap water daily for 6 months
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	*Old adults over 60 years old(regardless of gender)
Key exclusion criteria	*Persons who cannot give informed consent *Persons with a history of diabetes and hyperlipidemia *Persons with severe visual or hearing disabilities *Persons who have continuously drank natural reduced water in the last year
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Taki
Organization	Institute of Development, Aging and Cancer, Tohoku University.
Division name	Smart-Aging Research Center, Tohoku University.
Zip code	980-8575
Address	4-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
TEL	022-717-8559
Email	yasuyuki.taki.c7@tohoku.ac.jp

Public contact
Name of contact person	1st name Takamitsu Middle name Last name Shinada
Organization	Institute of Development, Aging and Cancer, Tohoku University.
Division name	Smart-Aging Research Center, Tohoku University.
Zip code	980-8575
Address	4-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
TEL	022-717-8824
Homepage URL
Email	takamitsu.shinada.c7@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Hita Tenryo-Sui 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 Tohoku University Graduate School of Medicine
Address	2-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2020 Year 09 Month 30 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	100
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 09 Month 01 Day
Date of IRB	2020 Year 09 Month 28 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2021 Year 05 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	2020 Year 09 Month 30 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047862