Healthy Japanese subjects
Conditions
Interventions
Duration: Two weeks Test food: Powdered beverage containing polyphenols Administration: Dissolve one packet with water and drink after lunch * Daily dose should be taken within the day. If you f
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who concerns about swollen legs 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose swelling volume of the lower leg are large at Scr
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed