Healthy Japanese subjects
Conditions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who are concerned about coldness of their hands and feet 6. Subjects whose the AUC of palmar skin surface temperature from immediately after cold water load is relatively low
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are undergoing medical treatment for anemia or cold sensitivity 5. Subjects who cannot use water in the cold season (whose fingertips change color to purple or white when these hands are put in water) 6. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 7. Subjects who usually take food/beverage with functional ingredients which may influence the thermoregulation (e.g., monoglucosyl hesperidin, polyphenols from ginger, 6-gingerol, 6-shogaol, piperines from Piper longum, ellagic acid, L-citrulline, flavonoid from Crataegus laevigata, hyperin, capsaicin, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or camelliasaponin B2) 8. Subjects who are currently taking medications (including herbal medicines) and supplements 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 11. Subjects who suffer from COVID-19 12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 13. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The area under the curve (AUC) of the palmar skin surface temperature from immediately to 30 minutes after cold water load at examination 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the palmar skin surface temperature at each measurement point, and the changes from measurements before and immediately after cold water load at 12w 2. The AUC of the palmar skin surface blood flow from immediately to 30 minutes after cold water load, the measured values at each measurement point, and changes from measurements before and immediately after cold water load at 12w 3. The subjective symptoms (coldness of fingertips, whole hands, and whole body) measured by visual analogue scale (VAS) before and 30 minutes after cold water load at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed