Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test food: Active food
Duration: Four weeks Test food: Placebo food
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 whose body weight is 40 kg or more 6. Individuals who are concerned about coldness of their hands and feet 7. Individuals whose the AUC of the right palmar skin surface temperature from immediately after cold water load is low among those meeting No.1~6 of the inclusion criteria and not meeting the exclusion criteria
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals 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. Individuals who are undergoing medical treatment for anemia or cold sensitivity 5. Individuals who cannot use water in the cold season (whose fingertips change color to purple or white when these hands are put in water) 6. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 7. Individuals who are taking food/beverage with functional ingredients which may affect 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. Individuals who are taking medications (including herbal medicines) and supplements 9. Individuals who are allergic to medicines and/or the test food related products 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study 11. Individuals who 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 12. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Evaluation after continuous intake for four weeks> 1. The area under the curve (AUC) of the right palmar skin surface temperature from immediately to 60 minutes after cold water load at examination four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| <Evaluation after continuous intake for four weeks> 1. The AUC of the left palmar skin surface blood flow from immediately to 60 minutes after cold water load at 4w 2. 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 4w 3. The measured values of the left palmar skin surface blood flow at each measurement point, and the changes from measurements before and immediately after cold water load at 4w 4. The measured value of each item in the original questionnaire about cold hands and body at each measurement point at 4w 5. The measured value of each item in the original questionnaire on physical condition at 4w 6. The measured values of blood flow velocity, blood vessel diameter, renin activity, three fractions of catecholamine, asymmetric dimethylarginine (ADMA), nitrogen oxide (NOx), and heat shock protein at 4w <Evaluation by single intake> 1. The AUC of the right palmar skin surface temperature from immediately to 60 minutes after cold water load at examination after consumption 2. The AUC of the left palmar skin surface blood flow from immediately to 60 minutes after cold water load at examination after consumption 3. The measured values of the right palmar skin surface temperature at each measurement point, and the changes from measurements before cold water load at examination after consumption 4. The measured values of the left palmar skin surface blood flow at each measurement point, and the changes from measurements before cold water load at examination after consumption 5. The measured value of each item in the original questionnaire about cold hands and body at each measurement point at examination after consumption 6. The measured values of blood flow velocity, blood vessel diameter, renin activity, three fractions of catecholamine, ADMA, NOx, and heat shock protein at examination after co | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed