Healthy adult
Conditions
Interventions
Ingestion one bottle (200ml/bottle) of test food once a day for approximately two menstrual cycles.
Ingestion one bottle (200ml/bottle) of placebo once a day for approximately two menstrual cycles.
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Healthy females from 20 to 44 years of age (2) Subjects with a stable menstrual cycle between 25 and 32 days (3) Subjects who suffer from menstrual pain within 5 days of the start of menstruation (4) Subjects whose usual menstrual cycle lasts 3-7 days based on their responses to a lifestyle questionnaire (5) Priority will be given to subjects who, based on their responses to the lifestyle questionnaire, usually consume little similar food, and subjects who have a high total score on the menstrual VAS during menstruation and the MDQ score before menstruation at the time of the pre-test. (6) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: (1) Subjects who regularly consume beverages similar to the test food (2) Subjects undergoing treatment for sex hormones, gynecological diseases, or taking birth control pills or related medications (3) Subjects who have had abnormalities in clinical test values or cardiopulmonary function and are deemed to be unsuitable for participation in the study (4) Subjects who are at risk of developing allergies related to the study (5) Subjects with a disease requiring regular medication, subjects with a disease currently being treated (excluding dry eye and caries treatment), subjects with a history of a serious disease that required medication (6) Subjects with a BMI of 30 kg/m^2 or more or less than 16 kg/m^2 (7) Subjects whose pre-examination anthropometric, physical and clinical test values are significantly outside the reference range (8) Subjects who are participating in the other study at the start of this study (9) Subjects who plan to or wish to receive cervical cancer (HPV) vaccination during the study period (10) Subjects who plan to become pregnant or breastfeed during the study period (11) Subjects who were deemed unsuitable as subjects based on their responses to the lifestyle questionnaire (12) Subjects who are judged as unsuitable for the study by the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in menstrual pain VAS from before to after intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in menstrual symptoms Japanese version (MDQ), PMTS-VAS, bowel movement frequency, menstrual blood volume score, and wearable data from before to after intake | — |
Countries
Japan
Contacts
Public ContactChiharu Goto
EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section
Outcome results
None listed