Healthy adults
Conditions
Interventions
Consumption of four MSHF001-containing tablets per day (two tablets each after breakfast and before bedtime) for four weeks.
Consumption of four placebo food tablets per day (two tablets each after br
Sponsors
Kao Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Healthy females Healthy females with hot flashes
Exclusion criteria
Exclusion criteria: -Subjects who are hot flashes 7 times a day or more, or 50 times a week or more. -Subjects with Kupperman index of 44 or higher. -Subjects with systemic illness. -Subjects who are diagnosed as menopausal disorders. -Subjects who are under Hormone Replacement Therapy (HRT). -Subjects who are outpatients or were treated by doctor within a month. -Subjects who are antidepressants, anxiolytics, hypnotic sedatives, taking drugs that affect psychiatric symptoms. -Subjects who have taken drugs or supplements (products mainly made with equol, isoflavones, and polyphenol-rich) that affect menopausal symptoms from 4 weeks before the screening trial. -Subjects who have been taking drugs or prescription drugs that affect the trial since 4 weeks before the start of the screening trial. -Subjects who are pregnant or lactating, or planned to become pregnant in the near future. -Subjects with smoking habit. -Subjects with drinking habit in every days (Alcohol equivalent 20g/day or more). -Subjects who have significantly disrupted the rhythm of their lives during the study period. -Subjects who have possibilities for emerging allergy to the ingredients contained in the test food, subjects with allergies such as drug allergy. -Subjects who plan to participate in other surveys or clinical trials between the time of recruitment and the end of the trial. -Subjects or their families engaged in the manufacture of health foods or supplements , market research company. -Subjects judged not appropriate by the physician responsible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of hot flashes | — |
Secondary
| Measure | Time frame |
|---|---|
| -Kupperman Kohnenki Shohgai Index (KKSI) -Menopause Symptom Assessment form -WHO QOL26 -WHO-5-J -The Brief Job Stress Questionnaire English version (B) -STAI -OSA sleep inventory MA version | — |
Countries
Japan
Contacts
Public ContactMayumi Ohtsuka
Kao Corporation Biological Science Research
Outcome results
None listed