Healthy volunteer
Conditions
Interventions
Intake of Isaria japonica supplement (4 tablets) with (lukewarm) water, once daily after breakfast, for 6 months.
Intake of placebo (4 tablets) with (lukewarm) water, once daily after breakfast, for 6
Sponsors
University of Occupational and Environmental Health, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individual with forgetfulness, and an MMSE score of 24 or more 2. Age: from 40 to 80 years-old 3. Male or female, native Japanese speaker
Exclusion criteria
Exclusion criteria: 1. Patients with diagnosed or suspected neurodegenerative disease that causes cognitive decline, such as Parkinson's disease, Lewy body dementia, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, multiple sclerosis 2. Patients suspected of having cognitive disorder caused by metabolic disease (hypothyroidism, low vitamin B12, folate deficiency), head trauma, normal pressure hydrocephalus, epilepsy, or encephalitis/meningitis 3. History of major depression, bi-polar disorder, schizophrenia, or drug addiction such as alcoholism, or current serious or unstable disease 4. Individuals with onset of stroke within the past 90 days 5. Patients receiving pharmaceutical treatment with an antidementia drug 6. Currently taking supplements aimed at improving cognitive function (such as ginkgo leaves, DHA, curcumin, omega fatty acids, or vitamin B12), or having taken any of these products in the 1 month prior to IC 7. HbA1c 8.0 % or more 8. BMI 30 kg/m2 or more 9. Individuals who have difficulty performing cognitive/emotional assessments or motor function tests 10. Individuals with an MMSE score of 23 or less at the start of the study 11. Individuals judged unsuitable for the study by the recruiting physicians or investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CogEvo and MMSE (after 6 months intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| CogEvo, MMSE (after 3 months intervention) HDS-R, ADCS-ADL, GDS, AS, ABS, oxidative stress, cytokine levels, p-tau 4-plex(Abeta40/42, NfL, GFAP), intestinal flora | — |
Countries
Japan
Contacts
Public ContactHiroaki Adachi
University of Occupational and Environmental Health, Japan Department of Neurology, School of Medicine
Outcome results
None listed