Healthy adults
Conditions
Interventions
Daily ingestion 10 tablets of active test food for 4 weeks.
Daily ingestion 10 tablets of placebo test food for 4 weeks.
Sponsors
Hokkaido Information University
National Agriculture and Food Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Japanese male and female between 30 and 50 years old, after obtaining consent. 3. Subjects without serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring report to the authorities. 4. Subjects with fatigue by work.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders. 2. Subjects with unusually high and/or low blood pressure and/or abnormal body measurement data and/or abnormal hematological data. 3. Subjects with severe anemia. 4. Subjects who are at risk of having allergic reactions to 28 food allergic substances or materials of test food. 5. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 6. Pre- or post-menopausal women complaining of obvious physical changes. 7. Pregnant, lactating women or women who expect to be pregnant during this study. 8. Subjects who regularly eat which contains materials of test foods within 4 weeks, prior to the current study. 9. Subjects who regularly take medicine, functional foods, and/or supplements which would affect sleep and/or stress. 10. Subjects who plan to travel abroad during this study. 11. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study, or subjects who do not agree not to donate blood during this study. 12. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study, or intend to participate in order clinical trials after obtaining consent to participate in this study. 13. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presenteeism | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleeping record, electroencephalogram during sleeping, heart rate variability, intestinal flora, urinary oxidative stress markers (8-hydroxy-2'-deoxyguanosine (8-OHdG), 8-isoprostane), survey on subjects' sleeping and mental and physical conditions. | — |
Countries
Japan
Contacts
Public ContactJun NISHIHIRA
Hokkaido Information University Health Information Science Center
Outcome results
None listed