UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056875 |
|---|---|
| Receipt number | R000064655 |
| Scientific Title | Investigation of the effects of using far-infrared blood circulation-promoting garments on capillaries, skin function, sleep, and body sensation |
| Date of disclosure of the study information | 2025/01/30 |
| Last modified on | 2026/03/13 16:32:34 |
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Basic information
Public title
Investigation of the effects of using far-infrared blood circulation-promoting garments on capillaries, skin function, sleep, and body sensation
Acronym
Investigation of the effects of using far-infrared blood circulation-promoting garments on capillaries, skin function, sleep, and body sensation
Scientific Title
Investigation of the effects of using far-infrared blood circulation-promoting garments on capillaries, skin function, sleep, and body sensation
Scientific Title:Acronym
Investigation of the effects of using far-infrared blood circulation-promoting garments on capillaries, skin function, sleep, and body sensation
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of wearing the test product on capillaries, skin function, sleep, and experience.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Capillary Assessment
(Week 0, Week 4, Week 8)
Key secondary outcomes
*Indexes for skin function(1)
*Sleep Assessment(1)
*Experience evaluation(1)
*Safety
1) Blood pressure, pulsation (1)
2) Weight, body fat percentage, BMI (1)
3) Doctor's questions (1)
4) Side effects/ Adverse events (2)
5) Subject's diary (3)
(1): Week 0, Week 4, Week 8
(2): Week 4, Week 8
(3): Every day from the start date of test product use to the end of the test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wearing the product under test (During the day, at bedtime, for 8 weeks).
Interventions/Control_2
Wearing a control product (During the day, at bedtime, for 8 weeks).
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women between 40 and 59 years of age at the time of obtaining consent to participate in the study.
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals who are aware of their cold nature compared to many others.
4) Individuals who are aware of coldness in the waist, limbs, or other parts of the body, and have daily problems such as swelling, tiredness, etc.
5) Individuals who have the habit of using body warmers or other measures to protect themselves from cold during the winter season.
6) Individuals who can consent to the use of the results of this study in a form that does not personally identify them for use in academic conferences, corporate advertisements, etc.
7) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
8) Individuals who can come to the designated venue for this study and be inspected.
9) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
Individuals
1) using medical products.
2) undergoing hormone replacement procedures.
3) with strange skin conditions at measurement points.
4) with metal allergies
5) with scars or inflammation in the evaluation area, as well as a history of cosmetic procedures or treatments in the evaluation area.
6) who used a drug to treat a disease in the past 1 month.
7) who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
8) who are a patient or have a history of or endocrine disease.
9) with depression, schizophrenia, or other mental disorders.
10) with severe anemia, sleep disorders requiring treatment.
11) whose BMI is over 25 kg/m2.
12) who are currently, or have been within the past month, habitual consumers of specified health foods, functional foods, or health foods, and individuals who plan to consume such foods during the study period.
13) who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
14) who are a smoker.
15) with high-intensity exercise habits and individuals on a diet.
16) who engage in a night work.
17) with irregular lifestyle or eating habits, and individuals who may change their lifestyle during the examination period.
18) who may develop skin irritation due to hay fever or seasonal allergic symptoms during the study period. Also, individuals who may use antiallergic drugs (eye drops are acceptable).
19) who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns.
20) who are pregnant, lactating or may become pregnant during the study period
21) Individuals who participated in other clinical studies in the past 1 month.
22) who are or whose family is engaged in healthy or functional foods.
23) judged inappropriate for the study by the principal.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Muto |
Organization
MTG Co.,Ltd.
Division name
Academic Planning Division
Zip code
453-0041
Address
MTG No. 2 HIKARI Building, 4-13 Honjintori, Nakamura-ku, Nagoya City, Aichi, 453-0041 Japan
TEL
070-5290-6753
takao.muto@mtg.gr.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MTG 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
| 2025 | Year | 01 | Month | 30 | 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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064655
