Healthy young women with menstrual-related symptoms
Conditions
Interventions
Continuous intake of the test beverage for two menstrual cycles
Continuous intake of the placebo beverage for two menstrual cycles
Sponsors
Kyoritsu Women's University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female university students aged 20-29 years 2. Residents of Japan 3. Individuals with a normal menstrual cycle (25-38 days) and menstrual duration of 3-7 days 4. Individuals experiencing discomfort symptoms from approximately 3 days before menstruation to around the third day of menstruation
Exclusion criteria
Exclusion criteria: 1. Individuals with diseases requiring ongoing medical treatment or follow-up 2. Individuals who are currently taking medications on a regular basis, or who start regular medication use during the study period (including hormonal agents and oral contraceptives) 3. Individuals with gynecological diseases (e.g., secondary amenorrhea, dysmenorrhea, endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), breast cancer, cervical cancer, endometrial cancer, ovarian cancer) 4. Individuals who dislike consuming the test beverage 5. Individuals who consume the test beverage >=5 days per week or >=7 servings per week 6. Individuals who are unable to discontinue the use of health foods (including dietary supplements), foods for specified health uses (FOSHU), foods with nutrient function claims, or foods with function claims during the study period 7. Individuals who are pregnant, breastfeeding, or intending to become pregnant during the study period 8. Individuals deemed unsuitable as study participants based on responses to the background questionnaire (lifestyle questionnaire) 9. Individuals who have participated in another clinical trial within 1 month prior to obtaining informed consent 10. Individuals with a score of 60 or higher on the Self-Rating Depression Scale (SDS) 11. Individuals whose total MDQ score after menstruation is higher than that before or during menstruation in the pre-survey (MDQ) 12. Individuals deemed unsuitable as participants by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total and mental symptom scores of the Menstrual Distress Questionnaire (MDQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical symptom score of the Menstrual Distress Questionnaire (MDQ), Sleep-related questionnaire score, and gastrointestinal symptom questionnaire score | — |
Countries
Japan
Contacts
Public ContactTomonori Unno
Kyoritsu Women's University Department of Food and Nutrition, Faculty of Home Economics
Outcome results
None listed