Healthy adult
Conditions
Interventions
Ingestion of test food 1 for 8 weeks
Ingestion of test food 2 for 8 weeks
Ingestion of placebo for 8 weeks
Sponsors
FANCL Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age: from 40 to 60 years old 2. Gender: Female 3. Menstruation: perimenopause (irregular menstruation in the last year) or postmenopause (less than 3 years from last menstruation) 4. Simplified Menopausal Index (SMI): 26 points or more 5.Hot flash: Daily hot flashes
Exclusion criteria
Exclusion criteria: 1. Subjects who have serious medical history 2. Subjects who have severe diabetes 3. Subjects who receive treatment and/or medicine, which affect to result of the study 4. Subjects who have mental illness 5. Subjects who have thyroid gland malfunction 6. Subjects who take medicine or health foods, supplement that may affect the results of this study 7. Subjects who have been taking hormone replacement therapy now or within 3 months from the start of the study 8. Subjects who are allergic to test food (soybean) 9. Subjects with irregular eating habits and sleep rhythms (eg, late-night workers) 10.Subjects who may develop seasonal allergies, such as hay fever, that may interfere with sleep and daily life during the test period 11. Subjects who intend to become pregnant or lactating. 12. Subjects who are planned to participate in other clinical study. 13. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simplified Menopausal Index(SMI), Severity and frequency of hot flash | — |
Secondary
| Measure | Time frame |
|---|---|
| POMS2-AS,AIS, unidentified complaints | — |
Countries
Japan
Contacts
Public ContactAkiko Goto
Kenkoin Medical Corporation Foundation Kenkoin Clinic
Outcome results
None listed