Healthy subjects
Conditions
Interventions
Intake of active food for 4 weeks - Washout period (more than4 weeks) - Intake of placebo food for 4 weeks
Intake of placebo food for 4 weeks - Washout period (more than4 weeks) - Intake of active foo
Sponsors
BHN Co., Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: "1. Japanese women aged 25 to 40 years at the time of obtaining written informed consent, with normal menstrual cycles (25-38 days) 2. Subjects who experience menstrual symptoms from 5 days before the start of menstruation to around the third day of menstruation 3. Subjects whose MDQ score is higher before menstruation than during menstruation 4. Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing."
Exclusion criteria
Exclusion criteria: 1. Individuals who have been diagnosed by a doctor with a gynecological disease {premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), secondary amenorrhea, menorrhagia, dysmenorrhea, endometriosis, uterine fibroids, breast cancer, cervical cancer, uterine cancer, ovarian cancer, etc.] 2. Individuals currently undergoing medication or outpatient treatment for any serious disease 3. Individuals currently undergoing exercise or diet therapy under the supervision of a doctor 4. Individuals at risk of developing an allergy to the test food 5. Individuals with a current or past history of drug or alcohol dependence 6. Individuals currently undergoing outpatient treatment for a mental disorder (depression, etc.) or sleep disorder (insomnia, sleep apnea syndrome, etc.), or individuals with a history of a mental disorder in the past 7. Individuals with irregular lifestyles due to night shifts or shift work, etc. 8. Individuals with extremely irregular lifestyles, such as eating and sleeping habits 9. Individuals with extremely unbalanced diets 10. Individuals with serious current or past illnesses, such as brain disease, malignant tumors, immune diseases, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases 11. Individuals using health foods, supplements, and medicines (such as low-dose birth control pills) that affect menstrual symptoms 12. Individuals who have participated in other clinical trials (research) within the three months prior to the date of consent acquisition, or who plan to participate in other clinical trials (research) during the study period 13. Individuals who have consumed 200 mL or 400 mL of ethanol within one month prior to the date of consent acquisition, or who have consumed 50 mL or 100 mL of ethanol within three months prior to the date of consent acquisitionThose who have drawn more than 100 mL of blood or donated blood components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual Distress Questionnaire (MDQ) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual pain VAS questionnaire, POMS2 short version | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
M&I Science CORP. Clinical Development Department
Outcome results
None listed