None listed
Conditions
Interventions
Test food intake (Two meals, lunch and dinner, shall be replaced with the test food and ingested daily.)
No test food intake (Keeping normal eating habits.)
Sponsors
NISSIN FOOD PRODUCTS CO., LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese females aged 20-44 years. 2) Individuals with symptoms of premenstrual syndrome (PMS). (Individuals who develop unfavorable mental or physical symptoms that last for 3 to 10 days before menstruation, and whose symptoms subside or disappear with the onset of menstruation.) 3) Individuals whose menstrual cycle is approximately 25 to 38 days and whose cycle fluctuation is within plus or minus 6 days 4) Individuals with regular lifestyle habits (ex. waking up time and bedtime). 5) Individuals whose written informed consent has been obtained. 6) Individuals who can visit an inspection facility and be inspected in designated days. 7) Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation index of premenstrual syndrome (PMS) symptom. | — |
Secondary
| Measure | Time frame |
|---|---|
| * 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) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed