Healthy subjects
Conditions
Interventions
Take 1 capsule of the test food for 12 weeks.
Take 1 capsule of the placebo food for 12 weeks.
Sponsors
Mibyou Life Science inc
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Japanese female aged older 45 years or and less than 55 years at the time of the informed consent 2) Subjects who feels their menstrual cycle, amount of menstrual blood, menstrual period, and degree of abdominal pain before and during menstruation have changed compared to those in their 20s (including menopause) 3) Subjects who feel menopausal symptoms (hot flashes, sweating) within the range that does not interfere with daily life 4) Subjects who are not suffering from serious diseases 5) Subjects who can enter examinations and records by visiting the hospital on a specified date 6) Subjects who have understood the purpose of the study and agreed to participate it by signing the written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects who are suffering from or treated for diseases that affect menopausal symptoms, including thyroid and psychological disorders 2) Subjects who are suffering from menopausal symptoms due to surgical procedures such as oophorectomy 3) Subjects who are judged by the principal investigator to require treatment such as medication for menopausal symptoms 4) Subjects who had a history of menopausal disorders 5) Subjects who regularly use pharmaceuticals, Food for Specified Health Uses, Foods with Functional Claims, health food, and supplements that affect this study 6) Subjects who have an allergy for the pharmaceuticals and foods that affect this study 7) Subjects who have hypersensitivity reactions for test foods 8) Subjects who drink more than 20 grams of alcohol per day 9) Subjects who smoke more than 20 cigarettes per day 10) Subjects who are unable to refrain from consuming Food for Specified Health Uses, Foods with Functional Claims, and other so-called health foods during the study 11) Subjects who have been participated in other clinical trial or trials, or wish to participate within the study period 12) Subjects who are unable to follow the doctor's instructions or are judged as an inappropriate candidate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman's menopausal index | — |
Secondary
| Measure | Time frame |
|---|---|
| Izumo scale SF-8 Japanese version Questionnaire for skin condition FSH Estrone Estradiol Defecation frequency Volume of stool Property of stool Enzymatic activity of stool | — |
Countries
Japan
Contacts
Public ContactSoichi Yoneda
Mibyou Life Science inc Clinical Trials Division
Outcome results
None listed