Healthy adults
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females from 50 to 79 years old at the time of the informed. 2.Subjects who get 24 or more in score of Mini Mental State Examination-Japanese (MMSE-J) , 17 or more in score of Montreal Cognitive Assessment-Japanese version (Moca-J) and 5 or less in score of The Geriatric Depression Scale-Short Form-Japanese (GDS-S-J). 3. Subjects who have the subjective symptom of forgetfulness, or who have been pointed out by relatives or acquaintances that they have objective symptoms of forgetfulness. 4. Subjects who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who are in the hospital or have a history of mental disorders (including depressive symptoms), cerebrovascular diseases, and sleep disorders. 2. Subjects who with severe liver, kidney, heart, respiratory organs, endocrine and metabolic diseases. 3. Smokers. 4. Alcohol addicts (those who drink 60 g or more of pure alcohol every day) and subjects with extremely irregular eating habits. 5. Subjects who cannot comply with restrictions on foods and supplements that affect the intestinal environment during in this study. 6. Subjects who took antibiotics within one month from the start date of this study. 7. Subjects who have undergone gastrointestinal surgery (excluding appendicitis). 8. Subjects who have experienced allergies to research food ingredients. 9. Subjects who taking medications (antipsychotics, anxiolytics, antidepressants, anti-Parkinson's diseases, antidepressants, antiepileptic drugs, anti-blood coagulants, etc.) that may affect cognitive function. 10. Subjects with impaired cognitive function tests due to impaired eyesight and hearing. 11. Subjects who routinely take foods and supplements that may affect cognitive function. 12. Subjects with current or a history of drug or alcohol dependence. 13. Subjects who are participating in research on ingestion of other foods or using medicines, research on applying cosmetics and medicines, subjects who participate in other research while participating in this study. 14. Subjects who are considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax after 12 weeks of ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitrax after 8 weeks of ingestion SF-36 Fecal bifidobacteria Blood inflammatory marker Blood BDNF | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed