Healthy subjects
Conditions
Interventions
Single dose of the test food
Single dose of the placebo food
Sponsors
Macromill Carenet, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Healthy females aged 20 to 39 years at the time of informed consent. (2)Subjects with a normal menstrual cycle (25 to 38 days) and a normal menstrual period (3 to 7 days). (3)Subjects with subjective symptoms of premenstrual syndrome (PMS). (4)Subjects who have received a full explanation of the study's purpose and content, have the capacity to consent, and have voluntarily provided their own electronic informed consent (eIC) with a full understanding of the study.
Exclusion criteria
Exclusion criteria: (1) Subjects falling under any of the following categories: a) Current heart, liver, or kidney disease (including complications of other diseases). b) History of cardiovascular disease. c) Current diagnosis of diabetes mellitus. d) Allergies to the test food. e) History of serious diseases such as cancer or tuberculosis. f) History of mental illness. (2) Subjects regularly using oral contraceptives (pill), ovulation inhibitors, hormone agents, medications for menstrual symptoms, or Chinese herbal medicine at the time of web screening (except for temporary use of OTC pain relievers for menstrual cramps or headaches only during premenstrual or menstrual periods). (3) Subjects taking health foods related to PMS at the time of web screening. (4) Subjects receiving medical treatment or medication for chronic diseases (gynecological, mental, thyroid, autonomic nervous system, or others) at web screening, or planning to do so during the study. (5) Subjects who are pregnant (including possible pregnancy), breastfeeding, or planning to become pregnant during the study. (6) Subjects diagnosed with PMDD by the investigator based on the PMDD assessment scale during web screening. (7) Subjects unable to stop consuming FOSHU (Food for Specified Health Uses), Foods with Function Claims, or other health supplements. (8) Subjects unable to stop consuming energy drinks. (9) Current smokers. (10) Subjects with an average daily alcohol intake exceeding 60g (pure alcohol equivalent). (11) Subjects with extremely irregular dietary habits. (12) Shift workers or night-shift workers. (13) Subjects whose living environment, dietary habits, or exercise habits may significantly change during the study. (14) Subjects currently participating in another study, or within 4 weeks of completing one, or planning to participate in another study during this period. (15) Subjects otherwise deemed ineligible by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Premenstrual Tension Syndrome - Visual Analog Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Daily Records of Severity of Problems (2) Profile of Mood States 2nd Edition | — |
Countries
Japan
Contacts
Public ContactNatsu Ikeyama
Macromill Carenet, Inc. Clinical Research Solution Department
Outcome results
None listed