Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Flavonoid.
Duration: 12 weeks Test product: Placebo
Sponsors
Toyo Sugar Refining Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Adults 4. Healthy individuals 5. Individuals whose Nugent Score is less than 7
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 3. Individuals who are 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 diagnosed with bacterial vaginosis, cervical cancer, or sexually transmitted disease 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking or using medicines (including herbal medicines) or supplements 7. Individuals who are taking or using medicines related to gynecology such as the pill 8. Individuals who cannot collect vaginal secretions according to the established procedure with a dedicated kit 9. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to citrus fruit 10. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles 11. Individuals who currently smoke or began smoking cessation within three months before providing informed consent 12. Individuals who habitually drink >= 60 g/day of alcohol 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. 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 15. 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 Nugent Score at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change of Nugent Score at 12w from screening (Scr) 2. The measured values of Lactobacillus type, Gardnella type, and Mobiluncus type at 12w, as well as their changes and percentage changes from Scr 3. The measured values of vaginal odor, vaginal dryness, vaginal itching, vaginal discomfort, vulvar pigmentation, vulvar dryness, vulvar itching, vulvar discomfort, amount of vaginal discharge, volume of menstrual bleeding, menstrual pain, menstrual distress, and pain during sexual intercourse (visual analogue scale; VAS) at 12w, as well as their changes and percentage changes from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed