Healthy Adult
Conditions
Interventions
8-day intake of test food
Sponsors
Ezaki Glico Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Japanese women residing in Japan who are between the ages of 18 and 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 between 25 and 38 days, and the duration of menstruation was between 3 and 7 days). (3)Individuals who can cooperate in consuming the test food daily during the intake period. (4)Individuals who have received sufficient explanation about the purpose and content of this study, possess the capacity to consent, can fully understand the content, and can provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Regular use of oral contraceptives, ovulation inhibitors, hormonal drugs, or medicines/Kampo for menstrual symptoms (except temporary use of OTC analgesics for menstrual pain or headache, or laxatives/antidiarrheals around menstruation). (2) Under treatment for PMS, PMDD, dysmenorrhea, or other gynecological diseases (e.g., menopausal disorder, hormone therapy, uterine/ovarian/breast disease), or scheduled for such treatment during the study. (3) Under treatment for thyroid disease, autonomic disorders, psychiatric disorders (e.g., depression, anxiety, insomnia, panic disorder), diabetes, or hyperlipidemia, or scheduled for such treatment. (4) Under treatment for chronic diseases (e.g., anemia, perennial allergy, asthma, hypertension). (5) History of cerebrovascular, cardiac, hepatic, or renal disease. (6) History of major gastrointestinal surgery (e.g., gastrectomy, intestinal resection; appendectomy not excluded). (7) Allergy to the test food. (8) Pregnant, lactating, possibly pregnant, or planning pregnancy. (9) Regular use of FOSHU, Foods with Function Claims, health foods, or supplements with specific ingredients. (10) Unable to discontinue such foods or supplements during the study. (11) Unwilling to restrict intake of general foods high in specific ingredients during the study. (12) Heavy smokers (about 21+ cigarettes/day). (13) Habitual alcohol intake >=20 g/day (approx. 180 mL sake, 500 mL beer, 110 mL shochu, or 200 mL wine). (14) Extremely irregular sleep or diet (e.g., shift/night workers). (15) Regular use of antibiotics during the study. (16) Expected major changes in living environment, diet, or exercise during the study. (17) Judged by the investigator as inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urinary metabolites pre- and post-intervention | — |
Countries
Japan
Contacts
Public ContactYoshihiro Hara
Ezaki Glico Co., Ltd. R&D Laboratory
Outcome results
None listed