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 their cold sensitivity 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose the AUC from immediately after cooling loading of palmar surface temperature 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 who currently undergoing treatment for any of the following chronic disease: 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 take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 7. Subjects who currently taking medications (including herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who suffer from COVID-19 11. 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 12. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The area under the curve (AUC) from immediately after cold water load of palmar surface temperature at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The AUC from immediately after cold water load of palmar surface blood flow at 12w 2. The palmar surface temperature at each measuring point at 12w 3. The palmar surface blood flow at each measuring point at 12w 4. The amount of change of palmar surface temperature between that before load and after each measuring point, and that immediately after cold water load and after each measuring point at 12w 5. The amount of change of palmar surface blood flow between that before load and after each measuring point, and that immediately after cold water load and after each measuring point at 12w 6. An original questionnaire about the coldness of the body at 12w 7. The amount of change of an original questionnaire about the coldness of the body between that before cold water load and after each measuring point at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed