Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059687) titled 'Exploration of Biometric Parameters Correlating with Digital Temperature Changes' on Dec. 31.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - KOBAYASHI Pharmaceutical Co., Ltd.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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)

Eligibility: Age-lower limit - 20 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 Size - 8

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068271

Disclaimer: Curated by HT Syndication.