Healthy Adult
Conditions
Interventions
Daily ingestion 30 g of active test food for 4 weeks.
Daily ingestion 30 g of placebo test food for 4 weeks.
Sponsors
Hokkaido Information University
Bioresource and Bioenvironment Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Subjects who are aware of their fatigue on a daily basis. 3. Subjects with physical-mental minor complaints.
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 serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 3. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 5. Subjects with severe anemia. 6. Pre- or post-menopausal women complaining of obvious physical changes. 7. Subjects who are at risk of having allergic reactions to drugs and/or foods especially citrus fruits. 8. Subjects who regularly take medicine, functional foods, and/or supplements which would affect fatigue. 9. Subjects who regularly take citrus fruits, citrus juices and/or umeboshi (Japanese pickled plums). 10. Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 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. 12. Pregnant or lactating women or women who expect to be pregnant during this study. 13. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 14. 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 |
|---|---|
| Improving physical-mental minor complaints after 4 weeks of ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate variability, electroencephalogram during sleeping, sleeping record, biomarkers in saliva (chromogranin A, IgA), VAS questionnaire on fatigue and stress, 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