Healthy volunteers
Conditions
Interventions
Sponsors
KOBAYASHI Pharmaceutical Co., Ltd.
Okayama Prefectural University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Japanese female subjects aged 18 years or older at the time of providing informed consent. Subjects with a normal menstrual cycle (between 25 and 38 days). Subjects with a menstrual duration of 3 to 7 days. Subjects with a Body Mass Index (BMI) of 18.5 kg/m2 or more and less than 25.0 kg/m2. Subjects who have received a full explanation of the study's purpose and procedures, have demonstrated good understanding, and have voluntarily provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Subjects currently receiving medication or outpatient treatment for any serious disease. Subjects with a history or current diagnosis of mental illness, diabetes, hepatic disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disorder, or other serious conditions. Subjects with severe menstrual pain that cannot be controlled even with analgesics. Subjects unable to perform physical exercise tests. Subjects unable to consume the prescribed study meals. Subjects who routinely (e.g., 3 times or more per week) consume over-the-counter (OTC) drugs, quasi-drugs, health foods, supplements, Foods for Specified Health Uses (FOSHU), or Foods with Function Claims, and are unable to discontinue their use after providing consent. Subjects who are currently pregnant or breastfeeding, or who intend to become pregnant during the study period. Subjects with an average daily alcohol consumption exceeding 60g of pure alcohol. Current smokers, or those with a smoking habit within one year prior to the start of the study. Subjects planning significant changes to their lifestyle (diet, sleep, exercise habits, etc.) during the study period, such as long-term travel. Subjects with extremely irregular dietary habits, or those with irregular life rhythms, such as shift workers or late-night workers. Subjects who have experienced a body weight fluctuation of 5% or more within the 3 months prior to the study. Subjects currently participating in another clinical trial, those within 4 weeks of completing another trial, or those planning to participate in another trial after consenting to this study. Other individuals judged as unsuitable for the study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| energy expenditure | — |
Secondary
| Measure | Time frame |
|---|---|
| body temperature, heart rate, autonomic nervous system activity indices (HRV), sweat rate, sleep parameters, salivary hormones, and various questionnaires. | — |
Countries
Japan
Contacts
Public ContactYukino Koshinaka
KOBAYASHI Pharmaceutical Co., Ltd. Life Science Research Department R&D Headquarters
Outcome results
None listed