Healthy Japanese
Conditions
Interventions
Duration: Approximately eight weeks (Two cycles of menstruation: 50 days~76 days) Test food: Active food
Duration: Approximately eight weeks (Two cycles of menstruation: 50 days~76 days) Test food
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. Adults 4. Healthy individuals 5. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDI)-II at Scr 6. Individuals whose menstrual cycle is between 25 and 38 days 7. Individuals whose lasting period of the menstruation is between 3 and 7 days 8. Individuals whose score of Neg Affect in the MDQ (before menstruation) is high at Scr
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 (ICD) 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 undergoing medical treatment or have a medical history of gynecological disease {such as premenstrual syndrome (PMS), premenstrual dysphoric Disorder (PMDD), secondary amenorrhea, dysmenorrhea, endometriosis, hysteromyoma, breast cancer, cervical cancer, endometrial cancer, or ovarian cancer} 5. Individuals who are undergoing medical treatment or have a medical history of immune system disease such as multiple sclerosis, lupus erythematosus, or any other autoimmune diseases 6. Individuals who have severe menstrual pain that cannot be controlled with analgesics 7. Individuals who are undergoing medical treatment or have a medical history of psychiatric disorder 8. Individuals who receive hormonal therapy 9. Individuals who are taking low-dose oral contraceptives regularly 10. Postmenopausal individuals 11. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 12. Individuals who are taking or using medications (including herbal medicines) and supplements 13. Individuals who are allergic to medicines or foods related to the test products 14. Individuals who are pregnant, lactating, or planning to become pregnant during this study 15. 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 16. 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 Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the 2nd examination after consumption (2nd) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and rate of change of Neg Affect in the MDQ (before menstruation) from screening (before consumption; Scr) at 2nd 2. The measured value of Neg Affect in the MDQ (during and after menstruation) at 2nd, and the amount and rate of changes of them from Scr 3. The measured values of Pain, Water Reten, Auto React, Impair Conc, Behave Change, Arousal, Control, and each item in the MDQ (before, during and after menstruation) at 2nd, and the amount and rate of changes of them from Scr 4. The measured values of Pain, Water Reten, Auto React, Neg Affect, Impair Conc, Behave Change, Arousal, Control, and each item in the MDQ (before, during and after menstruation) at the 1st examination after consumption (1st), and the amount and rate of changes of them from Scr 5. The measured values of transepidermal water loss (TEWL) and the moisture content of skin surface at 1st and 2nd, and the amount and rate of changes of them from Scr 6. The measured values of subjective Premenstrual Syndrome (PMS) symptoms measured by visual analog scale (VAS) at 1st and 2nd, and the amount and rate of change of them from Scr 7. The measured values of estradiol, progesterone, follicle-stimulating hormone, and luteinizing hormone at 1st and 2nd, and the amount and rate of changes of them from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed