Cognitively normal status at the preclinical stage of mild cognitive impairment
Conditions
Interventions
Test food: Tablets containing LPS from Pantoea agglomerans Duration of intake: 12 weeks Dosage and administration: 3 tablets daily intake
Control food: Pantoea agglomerans-derived LPS-free tablets
Sponsors
Nonprofit Organization Innate Immune Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, and have freely volunteered to participate in the trial with their consent obtained in writing. 2.Men and women aged 60 to 79 years. 3.Individuals who scored between 89 and 102 points on the Cognitrax test administered during screening (total score of language memory and visual memory: 60 points each, total 120 points). 4.Individuals who are able to consume the trial food provided daily in the specified amounts.
Exclusion criteria
Exclusion criteria: 1. Individuals who have been diagnosed with dementia by a physician 2. Individuals currently taking or who have previously taken medications for dementia 3. Individuals who cannot cease consumption of foods containing ingredients recognized to improve cognitive function 4. Individuals with severe symptoms of diabetes, liver disease, kidney disease, cerebrovascular disease, heart disease, malignant neoplasms, or other conditions 5. Individuals deemed unsuitable as participants based on responses to the participant background survey 6. Individuals with a history of alcohol dependence or current alcohol dependence 7. Individuals with injuries or illnesses that impair the ability to operate computers, smartphones, tablets, or other devices, or to perform cognitive function tests 8. Individuals who have reported food allergies to any components of the test food 9. Individuals with extremely irregular eating habits or lifestyle rhythms 10. Pregnant women, women who intend to become pregnant during the trial period, or women who are currently breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function measurement scores using the Cognitrax test 12 weeks after intake (Raw test scores and standardized scores for each cognitive domain, raw test scores and standardized scores for each cognitive domain comprising overall memory, and changes and rates of change from screening tests). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total score on the Mini-Mental State Examination (MMSE) 12 weeks after consumption of the test food (actual values, change from pre-consumption test, and rate of change) 2. Hippocampal volume measured by MRI (Brain Suite) (actual values and comparison values for same sex and age group, change from pre-consumption test, and rate of change) | — |
Countries
Japan
Contacts
Public ContactYuko Nakamoto
Nonprofit Organization Innate Immune Network Secretariat
Outcome results
None listed