UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059687 |
|---|---|
| Receipt number | R000068271 |
| Scientific Title | Finger Temperature and Circulatory Observation of Regional warming Effects Study - A Crossover Design (FiT-CORE study) |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/11/07 17:40:21 |
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Basic information
Public title
Exploration of Biometric Parameters Correlating with Digital Temperature Changes
Acronym
Exploration of Biometric Parameters Correlating with Digital Temperature Changes
Scientific Title
Finger Temperature and Circulatory Observation of Regional warming Effects Study - A Crossover Design (FiT-CORE study)
Scientific Title:Acronym
FiT-CORE Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the change in fingertip temperature in response to ambient temperature shifts and explore related factors influencing individual differences.
Basic objectives2
Others
Basic objectives -Others
Exploratory evaluation of the effects of topical heat application using a commercial heat patch on finger temperature during ambient temperature changes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between Core Temperature and Digital Surface Temperature
Key secondary outcomes
(1)Finger Surface Temperature (Measured by Thermography and iB Ring), Finger Vascular Diameter, Estimated Hemoglobin Level, Heart Rate Variability, Salivary Cortisol, Subjective Cold Sensation Questionnaire, Safety Assessments (Blood Pressure, Pulse Rate, Body Temperature)
(2)Safety and tolerability (based on questionnaire responses).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will wear a finger temperature measurement device and alternate every 40 minutes between rooms maintained at 25 and 15 degrees Celsius. Finger temperature will be measured throughout.
Interventions/Control_2
Intervention Group: Applying a commercial heat patch to the back and lower back
Control Group: No patch application (or Sham/Placebo application)
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese males and females aged between 20 and 50 years at the time of obtaining informed consent
(2) Individuals with a BMI between 18.5 and 25
(3) Individuals who have sufficient decision-making capacity, received a full explanation of the study objectives and procedures, fully understood the contents, voluntarily agreed to participate, and provided written informed consent
Key exclusion criteria
1. Currently receiving pharmacological treatment for any condition.
2. History of, or current treatment for, serious conditions (e.g., diabetes, kidney, liver, heart, thyroid, adrenal, or other metabolic diseases).
3. History or current diagnosis of autoimmune disorders (e.g., collagen disease, rheumatoid arthritis).
4. Taking medications regularly for chronic conditions.
5. Known allergies to metals or resins.
6. Implanted metal medical devices (e.g., pacemakers).
7. Visible inflammation, injury, or skin disorders (e.g., rash, eczema, ulcers) on the left hand.
8. Difficulty wearing a ring due to deformity, swelling, or limited mobility in the left hand.
9. Blood donation of >200 mL in the past month or >400 mL in the past 3 months.
10. Self-reported anemia.
11. Self-reported cold sensitivity (e.g., poor peripheral circulation).
12. History or current condition of drug or alcohol dependence.
13. Temperature-related symptoms (e.g., cold-induced urticaria, temperature-sensitive rhinitis or rashes).
14. Pregnant, lactating, or possibly pregnant.
15. Unable to remove hand accessories on the study day.
16. Participation in another clinical trial within the past 3 months.
17. Planning significant lifestyle changes (e.g., travel, diet, sleep, or exercise) during the study period.
18. History of adverse skin reactions to warming pads (e.g., heat packs).
19. Inflammation, injuries, eczema, rashes, tattoos, etc., on the lower back or back.
20. Any other condition deemed unsuitable by the principal investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Nishioka |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
m.nishioka@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Tsujikami |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
Homepage URL
m.tsujikami@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical 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
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-4405-1899
ethics_board@drc-web.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 | 12 | Month | 31 | 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 | 11 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | 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 | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068271
