Effects of a Test Food for Improvement of Premenstrual Syndrome (PMS).
- Conditions
- o
- Registration Number
- JPRN-UMIN000052973
- Lead Sponsor
- ISSIN FOOD PRODUCTS CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 100
Not provided
1) Individuals using medical products. 2) Individuals who regularly use hormonal drugs such as pills or other drugs. 3) Individuals who are patient or have a history of psychiatric disease, sleep disorder, high blood pressure, diabetes and hyperlipidemia. 4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung, digestive system and hematological disease. 5) Individuals who used a drug to treat a disease in the past 1 month(except temporal usage for pollenosis). 6) Individuals who are sensitive to the test food. 7) Individuals who have difficulty continuing to consume the test food during the test period 8) Individuals with irregular eating habits (missing one of breakfast, lunch, or dinner) and unbalanced eating. 9) Individuals who drink excessive amounts of alcohol on a daily basis 10) Individuals who habitually take the foods for specified health uses or functional food. 11) Individuals who may change their lifestyle, or who may be unable to visit the test venue by job transfer or relocation. 12) Individuals who use a mobile phone that is not an iPhone on a daily basis, and who have difficulty wearing the provided Apple Watch all day during the test period, except bath time. 13) Individuals who have difficulty conducting basal body temperature measurements and surveys using Apple Watch and mobile apps, which is conducted every day during the test period. 14) Individuals who are unable to properly store or consume the test foods due to reasons such as inability of setting the distributed freezer or non-possession of a microwave oven. 15) Individuals who are or are possibly pregnant, or are lactating. 16) Individuals who participated in other clinical studies in the past 3 months. 17) Individuals who themselves or their families work at companies or research institutions that develop, manufacture, or sell health and functional foods. 18) Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation index of premenstrual syndrome (PMS) symptom.
- Secondary Outcome Measures
Name Time Method * Secondary indexes 1.Indexes on sleeping 2.Blood/saliva biomarker indicators 3.Indexes for body composition 4.Indexes on quality of life * Exploratory endpoint 1.Physical and clinical examinations 2.Indexes on eating habit *Safety indexes 1.Doctor's questions 2.Side effects and adverse events 3.Subject's diary *Other indexes 1.Baseline characteristics 2.Height measurement 3.Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ)