Healthy Japanese subjects
Conditions
Interventions
Duration: Two weeks Test food: Active capsule A Administration: Take three capsules per day at any time during the day *Take three capsules 30 minutes before entering the high-temperature environ
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. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose body temperature are less than 37 degrees Celsius
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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are prone to anemia 5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 6. Subjects currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products 8. Subjects who are pregnant, breast-feeding, and planning to become pregnant 9. Subjects who suffer from COVID-19 10. 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 11. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The skin surface temperature measured with thermography at two weeks after consumption (2w) | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured values and amount of change from baseline in each of the following items at 2w: blood flow volume, Profile of Mood States 2nd Edition (POMS2) Japanese version, subjective symptom (Visual Analogue Scale), plasma cortisol, autonomic function, sweat rates, salivary cortisol, salivary amylase, and moisture of the skin | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed