Tokyo, Dec. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059905) titled 'A Study on the Effects of Natural Reduced Water Intake on Mental Health in Healthy Adults' on Dec. 25.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Tohoku University
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 malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To comprehensively elucidate the effects of continuous intake of natural reduced water on mental health through immune-related mechanisms.
Basic objectives2 - Efficacy
Intervention:
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
Eligibility:
Age-lower limit - 30
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 Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 27 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2027 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068506
Disclaimer: Curated by HT Syndication.
