Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Capsule containing Maca extract powder Administration: Take two capsules with water before sleep once a day * If you forget to take the test food, do not carry it
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged 45 or more and 60 or less 4. Healthy subjects 5. Subjects who have experienced natural menopause within three years 6. Subjects whose SMI are 26 or more and less than 50 7. Subjects who have relatively low "sleepiness on rising" (Zc score) of the OSA-MA among those meeting 1. ~ 6. of the inclusion criteria
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who live with infants less than one year old 8. Subjects who sleep with children (1 to 6 years old) 9. Subjects who live with and need to care for those in requiring long-term care 10. Subjects who sleep with more than one person 11. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift 12. Subjects who have nocturia two times or more 13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Zc score ("Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing" and "sleep length") of the OSA sleep inventory MA version (OSA-MA) at 8 weeks after consumption (8w) 2. Each item of the OSA-MA at 8w 3. The simplified menopausal index (SMI) at 8w 4. Each item of the SMI at 8w 5. Estradiol (E2) and follicle stimulating hormone (FSH) at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed