UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055969 |
|---|---|
| Receipt number | R000063941 |
| Scientific Title | Analysis of stress markers in biological samples |
| Date of disclosure of the study information | 2024/11/11 |
| Last modified on | 2024/11/05 12:43:56 |
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Basic information
Public title
Analysis of stress markers in biological samples
Acronym
Analysis of stress markers in biological samples
Scientific Title
Analysis of stress markers in biological samples
Scientific Title:Acronym
Analysis of stress markers in biological samples
Region
| Japan |
Condition
Condition
Stress response
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The stress response is a defense mechanism of the body that recovers from the health effects caused by stressors. Estimating the amount of stress using biomarkers (substances that exist in biological samples such as blood and urine and can be used as indicators of health status) is useful in medical research, but is not technically easy.
The applicant has previously developed a simple and highly accurate LCMS method for simultaneous measurement of cortisol and cortisone (Matsumoto et al., J Chromatogr B 2017). Although cortisol has large diurnal fluctuations and individual differences, making it difficult to evaluate in absolute terms, it has been shown that this problem can be solved by using the cortisol/cortisone ratio (Shimanoe et al., 2021. Matsumoto et al., 2020). In addition, the applicants are currently developing high-precision measurement methods for other biomarkers, such as catecholamines, peroxides, and other biologically active substances (Yamada et al., in preparation).
These measurements require special equipment, techniques, and experience, and it is inefficient and difficult to reproduce the developed methods at each research institution. Therefore, we will contribute to the development of science by jointly developing analytical methods for stress-induced biomarkers as joint research or commissioned research, and by sharing new methods and presenting high-precision analytical results (3) in this study).
In addition, we will analyze blood, urine, and saliva samples obtained from research collaborators who have been given exercise loads or psychological stress as positive controls for the above measurement system (4) positive control experiments).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we will evaluate the stress response to thermal radiation (heat exposure). The radiation intensity will be 0, 40, 50, and 60, and the radiation time will be 30 minutes.
The evaluation time is before exposure, after exposure, 30 minutes after exposure, and 3 hours after exposure. The main evaluation items are the anti-oxidant power and oxidation level in the blood, which are collected by fingertip blood collection, and the catecholamine and cortisol concentrations in the urine, which are calculated using the creatinine ratio.
Key secondary outcomes
Evaluates skin temperature increases.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
0 volt irradiation group.
Interventions/Control_2
This is the 40-volt light irradiation group.
Interventions/Control_3
This is the 45-volt irradiation group.
Interventions/Control_4
This is the 50-volt irradiation group.
Interventions/Control_5
This is the 55-volt irradiation group.
Interventions/Control_6
This is the 60-volt irradiation group.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those without subjective symptoms or serious heart disease
Key exclusion criteria
If you have a serious heart condition or are feeling unwell.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Matsumoto |
Organization
Saga University
Division name
Department of Social and Environmental Medicine, Faculty of Medicine,
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga-city, Saga
TEL
0952-34-2289
matsumoa@gmail.com
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Matsumoto |
Organization
Saga University
Division name
Department of Social and Environmental Medicine, Faculty of Medicine,
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga-city, Saga
TEL
0952-34-2289
Homepage URL
matsumoa@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
Department of Social and Environmental Medicine, Faculty of Medicine,
Tel
0952-34-3329
sv5587@cc.saga-u.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
佐賀大学医学部社会医学講座
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063941
