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The objective of this study is to demonstrate the cognitive enhancement effect and safety of Fermented Codonopsis lanceolata, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented Codonopsis lanceolata 525mg | Experimental | Fermented Codonopsis lanceolata 525mg/day |
|
| Fermented Codonopsis lanceolata 1050mg | Experimental | Fermented Codonopsis lanceolata 1050mg/day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented Codonopsis lanceolata 525mg | Dietary Supplement | Fermented Codonopsis lanceolata 525mg daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in standardized scores on a neuropsychological test battery | A composite z-scores were calculated from the scores of the neuropsychological test battery on attention and working memory. The test battery included Letter-number sequencing, Digit span (forward), and tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB) including the Match-to-Sample Visual Search, Reaction Rime, Rapid Visual Information Processing, and Stop Signal tasks. | baseline, 4th week, 8th week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in scores of the Subjective Memory Complaints Questionnaire | The Subjective Memory Complaints Questionnaire (SMCQ) contains 14 items and consists of two domains: global memory function and everyday memory function. The response to each item is rated as "yes" (1 point) or "no" (0 point). The total score ranges from 0 to 14 points, and higher points indicate larger degrees of subjective memory complaints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inkyoon Lyoo, MD, PhD, MMS | Ewha Womans University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University | Seoul | 03760 | South Korea |
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| Fermented Codonopsis lanceolata 1050mg | Dietary Supplement | Fermented Codonopsis lanceolata 1050mg daily for 8 weeks |
|
| Placebo | Dietary Supplement | Placebo daily for 8 weeks |
|
| baseline, 4th week, 8th week |
| Number of participants with adverse events | 4th week, 8th week |
| Changes of brain volume in magnetic resonance imaging assessed by computational approaches | Volumes of the clusters in the brain are reported in cubic millimeters | baseline, 8th week |
| Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches | Cortical thickness is measured in millimeters. | baseline, 8th week |
| Functional brain changes in magnetic resonance imaging assessed by computational approaches | The Blood Oxygenation Level Dependent (BOLD) signal intensities in arbitrary units are measured in each voxel of the brain. These values are compared between the time points and groups, and the statistical values are presented as results. | baseline, 8th week |
| Metabolic brain changes in magnetic resonance imaging assessed by computational approaches | Brain metabolite concentrations are assessed using the magnetic resonance spectroscopy and are estimated in mmol per liter. | baseline, 8th week |