Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing dried Aurantiochytrium Administration: Take one capsule with water once daily before sleep *If you forget to take the test food, take it as soon a
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 individuals 5. Individuals who are concerned about coldness of their hands and feet 6. Individuals whose AUC of palmar skin surface temperature from immediately after cold water load is low at screening (before consumption)
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are undergoing medical treatment or have a medical history of thyroid disease 5. are undergoing medical treatment or have a medical history of aspirin hypersensitivity 6. have hypotension (a systolic blood pressure less than 100 mmHg) 7. are undergoing medical treatment for anemia or cold sensitivity 8. are a smoker 9. cannot use water that flows out of the water pipes in the cold season (December~February) (whose fingertips change color to purple or white when these hands are put in water) 10. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 11. 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) 12. are taking or using medications (including herbal medicines) and supplements 13. are allergic to medicines and/or the test product related products 14. are pregnant, lactating, or planning to become pregnant during this study 15. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 16. 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 right 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 right palmar skin surface temperature at each measurement point, and the changes from measurements before and immediately after cold water load at 12w 2. The recovery rate of the right palmar skin surface temperature at each measurement point (except before and immediately after cold water load) at 12w 3. The AUC of the left 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 4. The subjective cold-related symptoms 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