UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059905 |
|---|---|
| Receipt number | R000068506 |
| Scientific Title | A Study on the Effects of Natural Reduced Water Intake on Mental Health in Healthy Adults |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/25 08:07:46 |
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Basic information
Public title
A Study on the Effects of Natural Reduced Water Intake on Mental Health in Healthy Adults
Acronym
A Study on the Effects of Natural Reduced Water Intake on Mental Health in Healthy Adults
Scientific Title
A Study on the Effects of Natural Reduced Water Intake on Mental Health in Healthy Adults
Scientific Title:Acronym
A Study on the Effects of Natural Reduced Water Intake on Mental Health in Healthy Adults
Region
| Japan |
Condition
Condition
(1) Age: Participants aged 30 to 64 years at the time of registration.
(2) Sex: Both males and females are eligible.
(3) Water Intake Requirement: Individuals who are able to consume 1 liter of natural reduced water or tap water daily throughout the 6-month study period.
(4) Informed Consent: Individuals who are capable of providing written informed consent to participate in the study.
(5) Stress Questionnaire: Individuals who have completed the stress-related questionnaire(s) required for the study.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively elucidate the effects of continuous intake of natural reduced water on mental health through immune-related mechanisms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores of stress-related questionnaires
Blood levels of stress-related proteins
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age: Participants aged 30 to 64 years at the time of registration.
(2) Sex: Both males and females are eligible.
(3) Water Intake Requirement: Individuals who are able to consume 1 liter of natural reduced water or tap water daily throughout the 6-month study period.
(4) Informed Consent: Individuals who are capable of providing written informed consent to participate in the study.
(5) Stress Questionnaire: Individuals who have completed the stress-related questionnaire(s) required for the study.
Key exclusion criteria
Participants who meet any of the following conditions at the time of registration will be excluded from this study.
Individuals with severe diseases, underlying conditions related to electrolyte abnormalities such as hyponatremia, or those taking medications that may cause such abnormalities will be excluded.
(1) Individuals who are unable to provide informed consent.
(2) Individuals with a history of dementia or neurological disorders.
(3) Individuals receiving medical treatment for any of the following chronic diseases:
- Renal diseases
- Cardiovascular diseases
- Liver cirrhosis
- SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion)
- Hypothyroidism
- Diabetes mellitus or hyperlipidemia
- Psychiatric disorders (including polydipsia associated with psychiatric conditions)
- Persistent vomiting or diarrhea
- Autoimmune or immunological diseases
- Electrolyte abnormalities
(4) Individuals taking any of the following medications:
- Antiepileptic drugs
- Antidepressants
- Diuretics
- Antihypertensive agents
- Antiarrhythmic drugs
(5) Individuals with severe visual or hearing impairments.
(6) Individuals who have consumed natural reduced water continuously within the past two years.
(7) Pregnant or breastfeeding women.
(8) Individuals currently participating in another clinical study.
(9) Individuals for whom participation in the study is deemed difficult by the investigators.
(10) Individuals who belong to the department(s) of the principal investigator or co-investigators (including affiliated or joint-appointment departments), such as students, graduate students, and staff.
(11) Individuals with a Body Mass Index (BMI) of less than 18.5kg/m^2.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku, 980-8575, Sendai
TEL
022-717-8824
takamitsu.shinada.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Soga |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku,Sendai
TEL
022-717-8824
Homepage URL
keishi.soga.b4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575
Tel
022-728-4105
ec-med@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
| 2025 | Year | 12 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068506
