UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061043 |
|---|---|
| Receipt number | R000069792 |
| Scientific Title | Investigation of the usefulness of measuring oral moisture level for assessing generalized dehydration in young people. |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/24 19:45:31 |
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Basic information
Public title
Verification of the possibility that oral moisture level measurement can predict dehydration in young people
Acronym
Predict dehydration by oral moisture level in young people
Scientific Title
Investigation of the usefulness of measuring oral moisture level for assessing generalized dehydration in young people.
Scientific Title:Acronym
Investigation of the relationship between oral moisture level and dehydration in young people.
Region
| Japan |
Condition
Condition
Dehydration
Classification by specialty
| Medicine in general | Pediatrics | Dental medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The recent increase in heatstroke cases due to extreme heat has become a social problem. While heatstroke is most common among the elderly, it also frequently occurs among younger age groups (7-18 years old) under school supervision, making it a significant issue from a school safety perspective. Dehydration is a major contributing factor, making it crucial to understand dehydration levels for heatstroke prevention.
However, dehydration often presents with few noticeable symptoms, making it important to monitor the condition over time before symptoms appear. Currently, however, there is no method for objectively and immediately assessing dehydration in schools and other settings.
Therefore, we focused on "oral moisture level." Oral moisture level can be easily measured using an oral moisture meter, and since thirst is closely related to dehydration, we hypothesized that it might be possible to estimate dehydration levels from oral moisture. We conducted an experiment applying this to assessing dehydration levels in athletes, and the data revealed a certain correlation between dehydration levels during sports activities and oral moisture level.
However, since studies have not yet been conducted on young people, whose saliva composition and secretion volume differ, it is questionable whether the results can be directly applied to school safety measures. Therefore, in this study, we planned an experiment with the aim of clarifying the correlation between oral moisture and dehydration in young people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after training, conventional dehydration assessment methods such as dehydration rate, sweat rate (calculated from body weight and water intake), and urine specific gravity are performed, along with oral moisture, saliva secretion volume (secretion rate), salivary osmotic pressure, and expression levels of salivary biomarkers (Cortisol, s-IgA, a-Amylase). The correlations between these measurements are then analyzed.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 7 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This program is for elementary school, junior high school, and high school students (ages 7-18, regardless of gender) who regularly engage in exercise.
Key exclusion criteria
Individuals with salivary gland disorders
Individuals diagnosed with xerostomia (dry mouth)
Other individuals deemed unsuitable by the principal investigator or co-investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kairi |
| Middle name | |
| Last name | Hayashi |
Organization
Institute of Science Tokyo
Division name
Department of Masticatory Function and Health Science
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-city, Tokyo
TEL
0358035522
k.hayashi.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kairi |
| Middle name | |
| Last name | Hayashi |
Organization
Institute of Science Tokyo
Division name
Departmento of Masticatory Function and Health Science
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-city, Tokyo
TEL
0358035522
Homepage URL
k.hayashi.spmd@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Sports Council
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-city, Tokyo
Tel
0358035522
k.hayashi.spmd@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will involve elementary, junior high school, and high school students (ages 7-18) belonging to sports clubs as research subjects. We will investigate dehydration levels and oral moisture conditions before and after training, and examine their correlation. Specifically, before and after training, we will measure body weight, urine specific gravity/osmolality, oral moisture levels (using an oral moisture meter), and saliva secretion rate (calculated from the amount of saliva collected over 2 minutes using the drooling method).
Management information
Registered date
| 2026 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069792
