Healthy Adult
Conditions
Interventions
Intake Test Food-1 for one menstrual cycle and one menstrual period
Intake Test Food-2 for one menstrual cycle and one menstrual period
Intake Test Food-3 for one menstrual cycle and one menstrual per
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Women aged 25 to 40 years. 2)Subjects with normal menstrual cycles, defined as the last three menstrual cycles being 25 to 38 days in length and menstrual periods lasting 3 to 7 days. 3)Subjects experiencing menstrual symptoms. 4)Subjects who work at least three days a week. 5)Subjects who can commit to daily consumption of the test food during the test food intake period. 6)Subjects who have been informed about the purpose and details of the study, possess the capacity to consent, understand the information thoroughly, and can provide consent electronically through informed consent.
Exclusion criteria
Exclusion criteria: 1)Subjects currently taking medications that affect menstrual symptoms, excluding those who temporarily take over-the-counter medications for menstrual pain or headache, or laxatives or antidiarrheals only before or during menstruation. 2)Subjects currently receiving medical treatment or medication for premenstrual syndrome, premenstrual dysphoric disorder or dysmenorrhea, other gynecological disorders, thyroid disorders, autonomic nervous system disorders, mental disorders, diabetes, or hyperlipidemia, or those who plan to receive medical treatment or medication during the study period. 3)Subjects with no menstrual pain or those with severe menstrual pain that cannot be controlled by over-the-counter medications. 4)Subjects with a chronic illness currently receiving medical treatment and medication. 5)Subjects at risk of developing an allergy to the test food. 6)Women who are breastfeeding, pregnant, or possibly pregnant, or who intend to become pregnant during the study period. 7)Subjects with a history of cerebrovascular disease, heart disease, liver disease, or kidney disease. 8)Subjects with a history of serious digestive system diseases such as gastrectomy, gastrointestinal suture surgery, or intestinal resection. 9)Subjects whose body weight <45 kg. 10)Subjects whose BMI <18.5 kg/m2 or >= 30 kg/m2. 11)Subjects who currently regularly consume functional foods, or health foods, and cannot stop taking such foods during the study period. 12)Subjects who are heavy smokers or heavy drinkers, and those with extremely irregular eating habits. 13)Subjects whose living environment may change significantly during the study period. 14)Subjects who are currently participating in other clinical trials, have participated in them within the past 8 weeks, or are scheduled to participate in other clinical trials during the study period. 15)Subjects who are otherwise deemed ineligible to participate by the principal investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PAF short version (total score) | — |
Secondary
| Measure | Time frame |
|---|---|
| PAF short version (subscale scores) PMTS-VAS POMS-2 adult-short version Original VAS OSA sleep inventory MA version WPAI Salivary Estradiol and Salivary Progesterone Stool frequency and shape | — |
Countries
Japan
Contacts
Public ContactYuki Mori
Macromill, Inc. Life Science Division Clinical Research Unit
Outcome results
None listed