Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063101) titled 'Effects of hydrogen-rich jelly intake on the human body: a randomized controlled trial' on Sept. 30.

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 participants with skin symptoms Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to investigate the effects of hydrogen-rich jelly intake on the human body, namely skin resilience, sleep quality and psychological status. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants ingest three pouches per day of hydrogen-rich jelly (High-Concentration Hydrogen Jelly; dissolved hydrogen concentration of 30 ppm or higher) for 9 weeks (plus or minus 1 week). In principle the three pouches are taken around the three daily meals; if a dose is missed, participants are instructed to take all three pouches within the same day. Intake is recorded daily by the participant on the study record form and reported at each visit. Interventions/Control_2 - Participants ingest three pouches per day of non-hydrogen jelly (jelly that does not contain hydrogen) for 9 weeks (plus or minus 1 week), under the same instructions as the hydrogen jelly group. The non-hydrogen jelly is manufactured at the same plant as the hydrogen jelly, is identical in all components other than hydrogen, is identical in colour and taste, and is packaged in the same aluminium pouch.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Healthy adults aged 20 to 60 years. "Healthy" is defined as having no health disorder identified at a health check-up and taking no regular oral medication. For this study, participants who take two or fewer oral drugs for allergic disease, orthopaedic disease, autonomic dysfunction, sleep disorder or dental disease, and participants who take dietary supplements, are also regarded as healthy. 2. Presence of skin symptoms, defined as a Dermatology Life Quality Index (DLQI) score of 3 or more. 3. Able to fully understand the purpose of the study and to provide informed consent to participate. Key exclusion criteria - 1. Judged inappropriate for the study by the principal investigator or a co-investigator. 2. Diagnosed with a lifestyle-related disease and receiving oral drug treatment at the time of participation. Lifestyle-related diseases are defined according to the Japan Association for the Prevention of Lifestyle-related Diseases as hypertension, dyslipidaemia, type 2 diabetes mellitus, chronic kidney disease, hyperuricaemia or gout, chronic obstructive pulmonary disease, and cancer. 3. Receiving oral drug treatment for cerebrovascular disease, cardiovascular disease, pulmonary disease, gastrointestinal disease, renal disease or autoimmune disease at the time of participation. 4. Use of any hydrogen-containing product within 1 week before obtaining informed consent. 5. Planning to use any hydrogen-containing product between obtaining informed consent and the end of the study. 6. Not agreeing to refrain from starting or changing any drug or dietary supplement for skin symptoms after obtaining informed consent. 7. Unable to understand the significance of the study because of dementia or a psychiatric disorder. Target Size - 32

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 28 Day Date of IRB - 2026 Year 09 Month 28 Day Anticipated trial start date - 2026 Year 10 Month 10 Day Last follow-up date - 2031 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072239

Disclaimer: Curated by HT Syndication.