Healthy adults
Conditions
Interventions
Daily ingestion 30 ml of active test food for 8 weeks.
Daily ingestion 30 ml of placebo test food for 8 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with informed consent for the study participation. 2. Subjects with minor health complaints.
Exclusion criteria
Exclusion criteria: 1. Subjects who participated in UMIN000042845. 2. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, sleep disorders, diabetes, hypertension, dyslipidemia, hypertension, and/or any other chronic diseases. 3. Subjects with implantable electronic medical devices. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on citrus fruits. 10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect fatigue. 11. Subjects who regularly take citrus fruits, citrus juices and/or umeboshi (Japanese pickled plums). 12. Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study. 14. Pregnant or lactating women or women who expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study. 16. 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 |
|---|---|
| The Brief Job Stress Questionnaire (Section B) at 8 weeks after beginning the intake of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS questionnaire on fatigue and stress, survey on subjects' sleeping and mental/physical conditions, biomarkers in saliva, heart rate variability, sleeping record. | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed