Healthy Japanese adult people
Conditions
Interventions
[1] Duration: 2 weeks Test material: Tablets containing lemon-derived, enzyme-treated hesperidin Administration: Take one tablet after dinner * If you forget to take the tablet, take it in the day
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult people who are suffering from facial swelling in daily 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who are not detected any renal dysfunction by urinalysis at screening 4. Subjects whose systolic blood pressure is below 130 mmHg at screening 5. Within the subjects who met 2nd to 4th inclusion criteria, select subjects with relatively high score in VAS related to facial swelling at screening
Exclusion criteria
Exclusion criteria: 1. A medical history of malignant tumor, heart failure or myocardial infarction 2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products * Particularly citrus fruits allergy 6. Subjects whose body mass index (BMI) is less than 18.5 kg/m2 or 30 kg/m2 or more 7. Subjects who work late-night shift or are irregular of their life-styles 8. Subjects who are pregnant, lactation, and planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective symptoms on swollen face * Visual Analogue Scale (VAS) * Assessed the item once at screening and in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Wrinkles on facial skin 2. Prominences on facial skin 3. Hemoglobin concentration on facial skin 4. Melanin concentration on facial skin 5. Facial volume 6. Facial dermal water content 7. Leg volume 8. Calf circumference 9. Subjective symptoms 10. Blood pressure *1-4 Measured by ANTERA 3D *5 Measured by VECTRA H1 *6 Measured by MoistureMeter D *7 Measured leg volume by a measuring device *8 Use a measuring tape *9 Assessed subjective symptoms by VAS *1-8 Assessed the items once at screening and in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake *9 Assessed the items in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake *10 Assessed the items once at screening and in the morning of intervention 1 and 2 before intake and 2 weeks after intake | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed