A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin): a randomized, double-blind, placebo-controlled, crossover trial
- Conditions
- Healthy Japanese adult people
- Registration Number
- JPRN-UMIN000031609
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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