An investigation study of drinking oxygenated water effects on oxygen saturations in blood on healthy humans: a randomized, double-blind, placebo-controlled, crossover trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000034753
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood oxygen saturations (SpO2) *Assess before consumption, immediately after consumption, and at 15 and 30 seconds after intake.
- Secondary Outcome Measures
Name Time Method 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.