A study of the effects of research food intake on fatigue in wome
- Conditions
- Healthy adult female
- Registration Number
- JPRN-UMIN000047170
- Lead Sponsor
- EP Mediate Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 60
Not provided
(1) Those who regularly use food fortified with plant-derived product. (2) Those who regularly use medicines, foods for specified health use, and health foods for the purpose of improving sleep, stress, and fatigue (including outpatient treatment and treatment). (3) Those who wake up in the middle of the night due to frequent urination. (4) Those who are undergoing treatment for sleep apnea syndrome, have a history of the diagnosis, or are strongly suspected of having the condition. (5) Those who work day and night shifts, those whose working hours are irregular, those who are engaged in physical labor such as heavy lifting, those whose working days (days off) are irregular, and those who will work multiple night shifts during this research period. (6) Those who have been diagnosed with chronic fatigue syndrome. (7) Those who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have problems participating in the research. (8) Those who are judged to be unsuitable as subjects based on their responses to the lifestyle questionnaire. (9) Persons at risk of developing allergies related to the research. (10) Those with diseases requiring constant medication (both external and internal), those with diseases under treatment (except for dry eye and dental caries treatment), and those with a history of serious diseases requiring medication (diabetes, liver disease, kidney disease, heart disease, etc.) (11) Persons whose physical measurements, physical test values, and clinical test values before the start of ingestion show significant deviations from the standard range. (12) Those who are participating in other clinical research at the start of this study. (13) Those who plan to become pregnant or breastfeed during the research period. (14) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method POMS2 adult shortening version Evaluate before ingestion, 4 weeks, 8 weeks, and 12 weeks after ingestion.
- Secondary Outcome Measures
Name Time Method OSA Wake-up Sleep Sense Questionnaire (MA Version), Fatigue VAS, Simplified Menopause Index (SMI) Evaluate before ingestion, 4 weeks, 8 weeks, and 12 weeks after ingestion. Saliva test (s-IgA concentration in saliva, s-IgA secretion in saliva per unit time) Evaluate before ingestion and 12 weeks after ingestion.