Tokyo, July 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062137) titled 'An Investigation into the Effects of Hydrogen-Enriched Water Consumption on Circadian Rhythms - A Randomised Controlled Pilot Trial -' on July 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Keio university
Condition:
Condition - healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim is to investigate the effects of drinking hydrogen-rich water on improving circadian rhythms in obese individuals.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consumption of hydrogen-rich water: 3 bottles of 245 ml each per day; intake period: 5 weeks
Interventions/Control_2 - Consumption of non-hydrogen-rich water (drinking water that does not contain hydrogen): 3 bottles of 245 ml each per day; intake period: 5 weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Healthy individuals aged between 20 and 60 with a BMI of 25 or above
2. Individuals with a slight decline in sleep quality (a score of 6 or above on the Pittsburgh Sleep Quality Index)
3. Individuals who fully understand the purpose of this trial and have consented to participate in it
Key exclusion criteria - 1. Individuals deemed unsuitable for this trial by the principal investigator or co-investigators
2. Individuals who have used a hydrogen product within one week of giving their consent
3. Individuals who intend to use a hydrogen product after giving their consent and until the end of the study
4. Individuals with dementia or a mental disorder who are unable to understand the significance of this study
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 03 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071104
Disclaimer: Curated by HT Syndication.