Healthy Japanese subjects
Conditions
Interventions
I. Active beverage II. Placebo beverage * The intervention sequence is I-II, and each beverage is single ingestion. * Drink test beverage (125 mL) under a stable state of heart rate *Washout peri
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who experiences difficulty breathing or fatigue in daily 3. Subjects who measured 97% or less in SpO2 at screening (before intake) 4. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements 6. Subjects who are an allergic reaction to medications 7. Subjects who have severe anemia, peripheral circulatory failure, angiopathy, or respiratory disease 8. Subjects who are wearing nail polish or applying cuticle oil to their nail 9. Subjects who are difficult to test because of hangnail, suppuration, or inflammation on the measurement part of the finger 10. Subjects who are difficult to test because of pigmentation on the measurement part of the finger 11. Subjects who are chipping off the cuticle on fingernails of the measurement part 12. Subjects who are pregnant, breast-feeding, or planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood oxygen saturations (SpO2) *Assess before consumption, immediately after consumption, and at 15 and 30 seconds after intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood oxygen saturations (SpO2) 2. Blood flow velocity 3. Visibility of vessels 4. Density of vessels 5. Diameter of vessels 6. Distance between vessels 7. Length of vessels 8. Shape of vessels *1 Assess before consumption, immediately after consumption, and at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 and 60 seconds. *2-8 Assess before consumption, immediately after consumption, and at 15, 30, 45, 60, 75, 90, 105 and 120 seconds. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed