Tokyo, Sept. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063031) titled 'Effects of 4-week continuous intake of mineral-rich water on skin condition and glycation-related indices' on Sept. 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - Age-related changes in skin condition and glycation-related indices Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine the effects of 4 weeks of continuous intake of mineral-rich water on skin condition and glycation-related indices associated with advanced glycation end products (AGEs) in women aged 50-69 years. Each participant will complete a 4-week control period during which usual lifestyle is maintained, followed by a 4-week mineral-water intervention period. Changes during the control and intervention periods will be compared within participants. Participants will be assigned to one of two groups with study initiation staggered by 2 weeks. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - [Group A: Earlier-start group] Participants will maintain their usual diet, fluid intake, physical activity, and lifestyle for the first 4 weeks without consuming the study mineral water. No additional restriction or prescribed intake of ordinary drinking water will be imposed. After the 4-week control period, participants will consume the study mineral-rich water continuously for 4 weeks while maintaining their usual lifestyle. Skin condition and the glycation-related index associated with AGEs will be assessed at baseline, week 4, and week 8. Both groups undergo the identical control and intervention periods; only the study start timing differs by 2 weeks between groups. Planned start date: September 24, 2026. Planned end date: around November 19, 2026. Interventions/Control_2 - [Group B: Later-start group] Participants will begin the study 2 weeks after Group A. Participants will maintain their usual diet, fluid intake, physical activity, and lifestyle for the first 4 weeks without consuming the study mineral water. No additional restriction or prescribed intake of ordinary drinking water will be imposed. After the 4-week control period, participants will consume the study mineral-rich water continuously for 4 weeks while maintaining their usual lifestyle. Skin condition and the glycation-related index associated with AGEs will be assessed at baseline, week 4, and week 8. Both groups undergo the identical control and intervention periods; only the study start timing differs by 2 weeks between groups. Planned start date: October 8, 2026. Planned end date: around December 3, 2026.

Eligibility: Age-lower limit - 50 years-old = Gender - Female Key inclusion criteria - 1. Women aged 50-69 years 2. Individuals who understand the study procedures and provide written informed consent 3. Individuals who are able to continuously consume the specified mineral-rich water for 4 weeks 4. Individuals who are able to participate in the scheduled assessments during the study period 5. Individuals who are able to maintain their usual lifestyle during the study period Key exclusion criteria - 1. Individuals with a disease, allergy, or other health condition considered incompatible with consumption of the study product 2. Individuals planning to initiate new treatment, health foods, or supplements during the study period that may substantially affect skin condition or glycation-related indices 3. Individuals who are unable to comply with the specified intake procedure or assessment schedule 4. Individuals judged by the principal investigator or co-investigators to be inappropriate for participation in the study Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 23 Day Date of IRB - 2026 Year 01 Month 08 Day Anticipated trial start date - 2026 Year 09 Month 24 Day Last follow-up date - 2026 Year 12 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072153

Disclaimer: Curated by HT Syndication.