Healthy adults
Conditions
Interventions
From day 5 of the first menstrual cycle (cycle 0) until 7 days after the end of the third menstrual cycle, participants will take the test food (two capsules) once daily with water.
From day 5 of the
Sponsors
KAGOME CO., LTD.
Macromill Carenet, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age between 20 years and under 40 years at the time of obtaining consent 2. Healthy Japanese women 3. Regular menstrual cycles and normal menstrual duration (Reference ranges: menstrual cycle of 25-38 days and menstrual duration of 3-7 days) 4. Presence of subjective premenstrual symptoms 5. Individuals who have received sufficient explanation regarding the purpose and content of this study, have the capacity to consent, fully understand the information, voluntarily agree to participate, and provide their own consent through electronic informed consent
Exclusion criteria
Exclusion criteria: 1. Individuals diagnosed with any disease or receiving treatment, preventive care, or medication (including herbal medicine), hormone replacement therapy, or scheduled to receive such treatment 2. Individuals with a history of cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine disorders 3. Individuals with a history of severe gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection; appendectomy only allowed) 4. Individuals judged to have a possible mental disorder based on SDS scores in Web-SCR 5. Individuals with a low premenstrual score on MDQ Form C (excluding the mood elevation item) in the Web-SCR 6. Individuals with a history of discomfort or health deterioration due to blood sampling 7. Individuals with food allergies 8. Individuals who have donated 200 mL of whole blood within 4 weeks, component blood within 2 weeks, or 400 mL of whole blood within 16 weeks prior to the Web-SCR 9. Individuals with significant abnormalities in blood, urine, or physical examinations 10. Individuals unable to discontinue quasi-drugs, herbal medicines, foods for specified health uses, functional foods, health foods, or foods containing herbs, lactic acid bacteria, or bifidobacteria during the study 11. Current smoker 12. Individuals who habitually consume alcohol (approximately 60 g or more per day) 13. Individuals with extremely irregular sleep or eating habits (e.g., shift workers) 14. Individuals likely to experience major changes in living environment, diet, or exercise habits during the study 15. Individuals who are breastfeeding, pregnant, possibly pregnant, or intending to become pregnant during the study 16. Individuals currently participating in another clinical study, who participated within 4 weeks before Web-SCR, or who plan to participate during the study 17. Individuals judged unsuitable by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Factor scale scores based on Mood Disorder Questionnaire (MDQ Japanese version) Form C (Negative Affect, Concentration, Behavioral Change scores, and the total score of these factors) | — |
Secondary
| Measure | Time frame |
|---|---|
| Factor scale scores based on MDQ Form C (Pain, Water Retention, Autonomic Dysregulation, Mood Elevation [Arousal], and Control scores, as well as the combined score of Pain, Water Retention, and Autonomic Dysregulation) Each score of PMTS-VAS (12 items) Each score of Shortened DRSP (8 items), subscale scores for psychological and physical symptoms, and the total score | — |
Countries
Japan
Contacts
Public ContactYumi Kimoto
Macromill Carenet, Inc. Clinical Trial Unit, Clinical Research Solution Department
Outcome results
None listed