Healthy adults
Conditions
Interventions
Daily intake of 0.9 g of active test food for 2 weeks.
Daily intake of 0.9 g of placebo test food for 2 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 feeling stress. 3. Subjects who show relatively low score of Brief Job Stress Questionnaire (BJSQ). 4. Subjects who show relatively low score of VAS questionnaire assessed stress. 5. Subjects who show relatively high score of heart rate variability (Ratio of LF to HF).
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depressive disorder, mania neurologic disorder, sleeping disorder, and/or diabetes. 2. Subjects who regularly take anticoagulant, antiplatelet medicine, and/or NSAIDs. 3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 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 hematological data. 6. Subjects with severe anemia. 7. Pre- or post-menopausal women complaining of obvious physical changes. 8. Subjects who are at risk of having allergic reactions to drugs or foods especially based on materials of test food and/or soybean. 9. Subjects who regularly take functional foods, and/or supplements which affect sleep and/or stress. 10. Subjects who regularly take drugs which affect bowel movements. 11. Subjects who have used as needed or continued to use antibiotics within 12 weeks prior to the current study. 12. Subjects who have a habit of taking material of test food over 200 g/day. 13. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 14. 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. 15. Pregnant or lactating women or women who expect to be pregnant during this study. 16. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 17. 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 |
|---|---|
| Heart rate variability at 2 weeks after beginning the ingestion of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| Electroencephalogram during sleeping, sleeping record, gut flora, blood metabolome, salivary amylase, questionnaire about subjects' background information, VAS questionnaire assessed stress. | — |
Countries
Japan
Contacts
Public ContactJun NISHIHIRA
Hokkaido Information University Health Information Science Center
Outcome results
None listed