Healthy Japanese
Conditions
Interventions
<
Duration>
Single administration (two periods) <
Test 1: Active food Test 2: Placebo food Lunch on each test day: Prescribed food <
Intervention sequence>
*Test 1 followed by Test 2. *The washout period will be two weeks. <
*Consume one capsule of the active food or placebo food with water after completing the morning measurements in each test of this study. *The prescribed meal will be consumed 2 hours after the start
Test 1: Placebo food Test 2: Active food Lunch on each test day: Prescribed food <
Sponsors
Fujicco Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged between 20 and 64 4. Healthy individuals 5. Individuals who are concerned about lower leg swelling 6. Individuals whose BMI is >= 18.5 kg/m2 and < 30.0 kg/m2 at screening 7. Individuals with a large diurnal variation in lower leg volume (swelling) at screening 8. Individuals whose systolic blood pressure is < 130 mmHg and diastolic blood pressure is < 90 mmHg at screening 9. Individuals with no abnormalities in kidney function as determined by urinalysis at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medicines (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals with drinking habits exceeding moderate consumption 8. Individuals whose lifestyles are irregular due to working a late-night shift or others 9. Individuals who are undergoing exercise or alimentary therapy under medical supervision 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study 11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 12. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of swelling volume (evening lower leg volume minus morning lower leg volume) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the lower leg volume in the morning and evening 2. The measured values of Visual Analogue Scale (VAS) for "I feel swelling face (cheeks or face line)," "I feel swelling around eyes," "I feel swelling calves," "I feel swelling the ankle (such as my socks feeling tight)," "I feel my complexion looks poor," and "I feel dark circles under my eyes" (Measurements include values in the morning, evening, and the following morning, as well as the difference between evening and morning values [evening minus morning], and between following morning and morning values [following morning minus morning]) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed