Healthy subjects
Conditions
Interventions
Take the test food for one menstrual cycle.
Take placebo food for one menstrual cycle.
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Women aged 20 to 40 at the time of obtaining consent to participate in the trial (2) Individuals with a normal menstrual cycle (the last three menstrual cycles were 25 to 38 days, and the menstrual period was 3 to 7 days) (3) Individuals with recognized premenstrual syndrome (PMS) symptoms (4) Individuals who have received adequate explanation of the purpose and content of this trial, possess the capacity to consent, have fully understood the information, voluntarily enrolled in the trial of their own free will, and whose consent can be obtained through electronic informed consent.
Exclusion criteria
Exclusion criteria: (1) Regular use of medications affecting premenstrual symptoms (e.g., oral contraceptives, hormones, OTC remedies), excluding temporary use of painkillers, laxatives, or antidiarrheals during the premenstrual period or menstruation. (2) Under treatment or planning treatment for PMS, PMDD, dysmenorrhea, other gynecological, thyroid, autonomic, or mental disorders. (3) History of gynecological disorders. (4) History of mental disorders. (5) Chronic conditions under treatment (e.g., anemia, allergies, asthma, diabetes, hyperlipidemia, hypertension). (6) History of major gastrointestinal surgery or serious GI disease (excluding appendectomy), or under GI treatment. (7) Pregnant, possibly pregnant, breastfeeding, or planning pregnancy during the study. (8) Allergic to the study product. (9) Regular use of health foods or supplements that cannot be discontinued. (10) Heavy smokers (21 or more cigarettes per day). (11) Regular alcohol consumption (60 g/day or more, 6 or more days/week). (12) Irregular sleep or eating habits (e.g., night or shift work). (13) Anticipated major changes in living, diet, or exercise during the trial. (14) Participation in another clinical trial within 4 weeks or during the study period. (15) Judged ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) menstrual symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Premenstrual symptoms (2) QOL questionnaire | — |
Countries
Japan
Contacts
Public ContactYuki Mori
Macromill, Inc. Clinical Trial Department , Life Science Division
Outcome results
None listed