Healthy adult
Conditions
Interventions
Daily ingestion of test food 1 for 24 weeks.
Daily ingestion of test food 2 for 24 weeks.
Daily ingestion of test food 3 for 24 weeks.
Daily ingestion of placebo food for 24 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Japanese males and females between 60 and 80 years old at the time of screening test. 3. Subjects who are aware of their cognitive decline, such as forgetfulness. 4. Subjects with relatively low total MoCA-J score at the time of screening test. 5. Subjects who can carry out cognitive function test, write diary and questionnaire.
Exclusion criteria
Exclusion criteria: 1. Subjects whose total MMSE score is <= 23 points. 2. Subjects who are under medication for dementia, Alzheimer's disease, psychiatric disorder and cerebrovascular disease. 3. Subjects with a history or suspected of psychiatric disorder and cerebrovascular disease. 4. Subjects with implantable electronic medical devices. 5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory diseases, and/or affected with infectious diseases requiring reports to the authorities. 6. Subjects with major surgical history relevant to the digestive system. 7. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects with dysphagia. 11. Subjects who may have allergic reactions to drugs, foods or plants (especially gelatin, mango, urushi, pistachio, cashew nut, latex rubber and birch). 12. Subjects who regularly take medicine, functional foods which would affect cognitive function. 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. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current 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 |
|---|---|
| Cognitive assessment (MoCA-J, logical memory I and II of the WMS-R, digit symbol substitution test of the WAIS-IV, S-PA) and blood amyloid-beta composite biomarker after 24 weeks of ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mental activity assessment, blood amyloid-beta binding exosomes, blood sphingolipids | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed