UMIN-ICDS Clinical Trial

Public title

Effects of 4-week continuous intake of mineral-rich water on skin condition and glycation-related indices

Acronym

Mineral Water Skin and Glycation Study

Scientific Title

Effects of 4-week continuous intake of mineral-rich water on skin condition and advanced glycation end products: a randomized staggered-start intervention study

Scientific Title:Acronym

Mineral Water Skin Aging Study

Region

Japan

Condition

Age-related changes in skin condition and glycation-related indices

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome is the difference between the change in the glycation-related index associated with AGEs during the 4-week control period and the change during the subsequent 4-week mineral-water intervention period. Measurements will be performed at weeks 0, 4, and 8 for each participant. Control-period change: week 4 minus week 0. Intervention-period change: week 8 minus week 4. The primary analysis will compare the changes during the control and intervention periods within participants.

Key secondary outcomes

Secondary outcomes include skin texture, skin brightness, skin spots, skin aging-related indices, and skin moisture. Each outcome will be assessed at weeks 0, 4, and 8. Changes during the 4-week control period and the subsequent 4-week mineral-water intervention period will be calculated and compared within participants.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

69

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 sample size

30

Name of lead principal investigator

1st name	Shiho
Middle name
Last name	Kurosaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8524

Address

1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima 739-8524, Japan

TEL

082-424-6844

Email

shihok@hiroshima-u.ac.jp

Name of contact person

1st name	Shiho
Middle name
Last name	Kurosaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8524

Address

1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima 739-8524, Japan

TEL

082-424-6844

Homepage URL

Email

shihok@hiroshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

JES Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee, Graduate School of Humanities and Social Sciences, Hiroshima University

Address

1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima 739-8524, Japan

Tel

082-424-6705

Email

shihok@hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広島大学（広島県）
Hiroshima University (Hiroshima, Japan)

Date of disclosure of the study information

2026

Year

09

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is conducted under a collaborative research agreement between Hiroshima University and JES Co., Ltd. JES Co., Ltd. provides research funding and the mineral-rich water used as the study product but has no role in the study design, participant recruitment or allocation, conduct of the intervention, measurements, data collection or management, statistical analysis, or interpretation of the results.

Registered date

2026

Year

09

Month

23

Day

Last modified on

2026

Year

09

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072153