Effects of consumption of the test food on the coldness of the body in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000047708
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 56
Not provided
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 who 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 undergoing medical treatment for anemia or cold sensitivity 5. Subjects who cannot use water in the cold season (whose fingertips change color to purple or white when these hands are put in water) 6. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 7. Subjects who currently taking medications (including herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who suffer from COVID-19 11. 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 12. 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 1. The area under the curve (AUC) from immediately after cold water load of palmar surface temperature at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method 1. The AUC from immediately after cold water load of palmar surface blood flow at 12w 2. The palmar surface temperature at each measuring point at 12w 3. The palmar surface blood flow at each measuring point at 12w 4. The amount of change of palmar surface temperature between that before load and after each measuring point, and that immediately after cold water load and after each measuring point at 12w 5. The amount of change of palmar surface blood flow between that before load and after each measuring point, and that immediately after cold water load and after each measuring point at 12w 6. An original questionnaire about the coldness of the body at 12w 7. The amount of change of an original questionnaire about the coldness of the body between that before cold water load and after each measuring point at 12w