UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062272 |
|---|---|
| Receipt number | R000071259 |
| Scientific Title | Effects of Wearing Recovery Wear on SIgA and Heart Rate After Exercise |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/07/17 19:34:34 |
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Basic information
Public title
Effects of Wearing Recovery Wear on SIgA and Heart Rate After Exercise
Acronym
Effects of Wearing Recovery Wear on SIgA and Heart Rate After Exercise
Scientific Title
Effects of Wearing Recovery Wear on SIgA and Heart Rate After Exercise
Scientific Title:Acronym
Effects of Wearing Recovery Wear on SIgA and Heart Rate After Exercise
Region
| Japan |
Condition
Condition
Healthy Person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of wearing recovery wear on salivary SIgA after exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary SIgA
Key secondary outcomes
1.Heart rate
2.Salivary cortisol
3.Height
4.Weight
5.Body fat percentage
6.BMI
7.Fatigue scores using the Visual Analog Scale
8. the Japanese version of profile of Mood States Second Edition (POMS 2)-Short Form
9.Rate of perceived exertion
10.Questionnaire
11.Adverse Events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Recovery Wear
Interventions/Control_2
Placebo
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Members of the track and field team.
Individuals who engage in track and field on a regular basis.
Individuals who agree to abide by the prohibitions set forth in this study.
Individuals who consent to the use of study results - in a manner that ensures personal anonymity - for purposes such as academic presentations or corporate advertising.
Individual with the capacity to consent who has received a full explanation of this study, has understood it well, and has voluntarily provided informed consent either online or in writing.
Key exclusion criteria
Individuals with serious medical conditions - such as diabetes mellitus, liver disease, kidney disease, heart disease, or cardiovascular disease - or a history thereof.
Individuals currently undergoing treatment for a medical condition, or those with a history of serious illness requiring pharmacological treatment.
Individuals who are not medically cleared for full participation in sports or exercise due to conditions such as heart disease.
Individuals who cannot refrain - during the study period - from the oral intake of new health foods (including supplements affecting the circulatory or metabolic systems), quasi-drugs, or over-the-counter (OTC) medicines, or from the use of topical anti-inflammatory analgesics (such as compresses).However, individuals prescribed such products by a physician or pharmacist for therapeutic purposes must consult them regarding whether to discontinue use; furthermore, if use is unavoidable, it must be carried out with the agreement of the research institution.
Individuals unable to refrain from drinking alcohol or smoking during the study period.
Individuals whose health condition could deteriorate due to wearing the test product (e.g., due to allergies).
Individuals who are pregnant, breastfeeding (including those planning to stop breastfeeding), or intending to become pregnant during the study period.
Individuals who have participated in another clinical study within the past month or plan to participate in another clinical study after consenting to participate in this study.
Any other individuals deemed unsuitable as study participants by their attending physician or the principal investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Muto |
Organization
MTG Co., Ltd.
Division name
VITALTECH Division Academic Planning Section
Zip code
460-0008
Address
Nagoyafushimi I-mark Bldg.8F, 1-23-10 Sakae, Naka-ku, Nagoya, Aichi, Japan
TEL
052-481-5001
takao.muto@mtg.gr.jp
Public contact
Name of contact person
| 1st name | Toshitaka |
| Middle name | |
| Last name | Miki |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
Homepage URL
toshitaka.miki@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA 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
Shiba Palace Clinic Ethics Review Committee
Address
Daiwa A Hamamatsucho Bldg. 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 07 | Month | 20 | 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
22
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Publication of the results has been delayed because manuscript preparation are currently in progress.
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 21 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071259
