Healthy subjects
Conditions
Interventions
Intake test food 1 for 4 weeks
Intake test food 2 for 4 weeks
Intake of the placebo food for 4 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Women aged 20 to 49 years. (2) Subjects who experience temporary discomfort associated with the menstrual cycle. (3) Subjects with a menstrual cycle of approximately 26 to 32 days, with a cycle variability within 6 days. (4) Subjects who received sufficient explanation about the purpose and procedures of the study, had the capacity to provide consent, voluntarily agreed to participate after fully understanding the study, and provided written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious diseases. (2) Subjects who have undergone gastrointestinal surgery. (3) Subjects showing abnormal liver and kidney function test values. (4) Subjects with diseases currently being treated. (5) Subjects with food or drug allergies. (6) Subjects with symptoms of anemia. (7) Female subjects who wish to become pregnant during the study, or who are pregnant (including those who may be pregnant) or breastfeeding. (8) Subjects taking hormone medication. (9) Subjects who play intense sports or who are on a diet. (10) Subjects with extremely irregular eating habits. (11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) or quasi-drugs during the study period. (12) Subjects who are continuously undergoing treatment with pharmaceuticals (including OTC and prescription medications). (13) Subjects who drink more than 40 g of pure alcohol per day on average. (14) Subjects who smoke an average of 21 or more cigarettes per day. (15) Subjects who are participating in or will participate in other clinical trials at the start of this study. (16) Subjects who are deemed inappropriate for the study by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mood Disorder Questionnaire Premenstrual Symptoms Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2nd Edition Short Form Clinical tests, Height and weight Serum sex hormone parameters: estradiol and progesterone Metabolome analysis (health claim prediction) PMS memory Basal body temperature Ovulation day Quantification of six urinary isoflavones (equol, daidzein, genistein, glycitein, daidzin, and genistin) urinary 5 HIAA (a serotonin metabolite) | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed