Healthy adults
Conditions
Interventions
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.
In
Sponsors
KOBAYASHI Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between Core Temperature and Digital Surface Temperature | — |
Secondary
| Measure | Time frame |
|---|---|
| (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). | — |
Countries
Japan
Contacts
Public ContactMasaya Tsujikami
KOBAYASHI Pharmaceutical Co., Ltd. Life Science Research Department R&D Headquarters
Outcome results
None listed