UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058966 |
|---|---|
| Receipt number | R000067266 |
| Scientific Title | Physiological and Psychological Effects of Wearing Black Silica-Infused Clothing |
| Date of disclosure of the study information | 2025/09/02 |
| Last modified on | 2025/09/02 15:23:19 |
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Basic information
Public title
Verification of the Effects of Wearing Clothing Made from Black Silica Materials on Physical and Mental Health
Acronym
BS-Cloth Study
Scientific Title
Physiological and Psychological Effects of Wearing Black Silica-Infused Clothing
Scientific Title:Acronym
BS-Cloth Study
Region
| Japan |
Condition
Condition
Cold sensitivity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of continuous wearing of clothing made from black silica materials on physical and mental health in healthy individuals aged 30 to 60 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Immune function, inflammation, and cardiovascular-metabolic indicators
Immune cells (NK cells, T cells, B cells, etc.)
Plasma proteome analysis (737 proteins related to inflammation and cardiovascular-metabolic function)
2. Psychological questionnaires
Quality of life: WHO QOL-26
Mood states: Profile of Mood States 2 (POMS2)
Stress level: Perceived Stress Scale (PSS)
Depressive tendency: Kessler 10 (K10; psychological distress screening scale)
3. Cognitive function tests
Processing speed and working memory: Trail Making Test A/B (TMT-A/B)
Sustained attention: 10-min Psychomotor Vigilance Task (PVT)
Executive function: Stroop task, Flanker task, n-back task
4. Fatigue assessment
Fatigue and recovery: Visual Analogue Scale (VAS)
Fatigue accumulation: Cumulative Fatigue Symptoms Index, Self-diagnostic Checklist for Worker Fatigue Accumulation, Japanese version of Checklist Individual Strength Questionnaire (CIS-20)
5. Physical and motor function
Anthropometry: height, weight, body composition
Motor performance tests: step-up test, two-step test, single-leg stance with eyes open/closed, vertical jump
6. Femtech-related assessments (female participants)
Premenstrual dysphoric disorder: PMDD Rating Scale
Premenstrual syndrome symptoms: Shortened Daily Record of Severity of Problems (DRSP)
7. Sleep evaluation
Pittsburgh Sleep Quality Index (PSQI)
OSA Sleep Inventory MA version
8. Clothing usage survey
Questionnaire on clothing usage status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wear a set of clothing made of fiber containing black silica (BS Fine).
Participants will be asked to wear the clothing as much as possible in daily life for a period of three months during the winter season. Wearing will take place in the context of ordinary daily activities, and no restrictions such as special exercise programs or dietary limitations will be imposed. Participants will be instructed to record their clothing usage status every day.
Interventions/Control_2
Control group: Wear a set of clothing made of the same type of material without black silica woven into it.
Participants will be asked to wear the clothing as much as possible in daily life for a period of three months during the winter season. Wearing will take place in the context of ordinary daily activities, and no restrictions such as special exercise programs or dietary limitations will be imposed. Participants will be instructed to record their clothing usage status every day.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(3) Healthy men and women aged 30 to 60 years
(2) Individuals who are able to wear clothing made of black silica-containing fabric during the study period
(1) Individuals who provide written informed consent to participate in the study
Key exclusion criteria
(1) Individuals who are unable to provide informed consent
(2) Individuals with a history or current diagnosis of dementia, psychiatric disorders, or neurological diseases
(3) Individuals with severe visual or hearing impairments
(4) Individuals who are currently participating in another clinical study
(5) Individuals who are otherwise judged to be unsuitable for participation in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-Cho, Aoba-ku, Sendai, Miyagi
TEL
022-717-8582
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Kawamura |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-Cho, Aoba-ku, Sendai, Miyagi
TEL
022-717-8824
Homepage URL
takuji.kawamura.b8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Yasuyuki Taki
Funding Source
Organization
Kamo Seni Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学加齢医学研究所、東北大学スマート・エイジング学際重点研究センター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 02 | 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
| 2025 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067266
