Effects of consumption of the test food on the swelling in health Japanese sucjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000045342
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 4
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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hypotension, hemorrhagic disease, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. 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 9. Subjects who have surgery within the last 14 days before the agreement to participate in this trial or plan of surgery during the consumption 10. 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 measured value of the swelling volume of the lower leg*1 at two weeks after consumption (2w) *1It is calculated by subtracting the lower leg volume in the morning from that in the evening
- Secondary Outcome Measures
Name Time Method 1. The measured value at 2w of the following items: the lower leg volume in the morning or evening, the facial swelling volume*2, subjective symptoms of swollen legs or face (visual analogue scale), and calf circumference (maximum circumference of the lower leg) *2It is calculated by subtracting the face volume in the morning from that in the evening