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
Female
Inclusion criteria
Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Subjects without serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring report to the authorities. 3. Workers. 4. Subjects with minor health complaints.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, sleep disorders and/or chronic fatigue syndrome. 2. Subjects with suspected depression. 3. Subjects with implantable electronic medical devices. 4. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5. Subjects with unusually high and/or low blood pressure and/or abnormal body measurement data and/or abnormal hematological data. 6. Subjects whose BMI is <16 kg/m2 or >=30 kg/m2 7. Subjects with severe anemia. 8. Subjects who are at risk of having allergic reactions to 28 food allergic substances and/or materials of test food. 9. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 10. Pre- or post-menopausal women complaining of obvious physical changes. 11. Pregnant, lactating women or women who expect to be pregnant during this study. 12. Subjects who regularly take which contains materials of test foods. 13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect sleep and/or stress. 14. Subjects who plan to travel abroad during this study. 15. Subjects whose lifestyle changed within a year prior to the current study. 16. Subjects whose lifestyle is expected to change. 17. Subjects who donated either 400 ml whole blood within 16 weeks, 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study, or subjects who do not agree not to donate blood during this study. 18. 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. 19. 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 |
|---|---|
| POMS 2 full-length versions for adults after 4 weeks of ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate variability, electroencephalogram during sleeping, survey on subjects' sleeping and mental and physical conditions, sleeping record, blood oxidative stress markers, urinary 8-OHdG. | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed