Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions in Healthy Adults With Subjective Memory Impairment: An 8-week Prospective Randomized Double-Blind Placebo-Controlled Trial With Multimodal Neuroimaging and Neurocognitive Assessments

Conditions
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Subjective Memory Complaints

Intervention / Treatment
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* Dietary Supplement: Fermented Codonopsis lanceolata 525mg
* Dietary Supplement: Fermented Codonopsis lanceolata 1050mg
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 65 years old Global Deterioration Scale score (GDS) of 2 High school or higher levels of education With informed consent Exclusion Criteria: Evidence of neurologic or medical conditions Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV) Mini-mental status examination score of 25 or less Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits Intelligence quotient less than 70 Any history of head trauma involving loss of consciousness or seizure Contraindications to magnetic resonance imaging (MRI) Use of psychotropics in last 3 months Allergic adverse reactions to Fermented Codonopsis lanceolata Participation in other clinical trials during the study period that might affect the outcome of the present study Use of oral contraceptive medication Current pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented Codonopsis lanceolata 525mg<br>Fermented Codonopsis lanceolata 525mg/day | Dietary Supplement: Fermented Codonopsis lanceolata 525mg<br>* Fermented Codonopsis lanceolata 525mg daily for 8 weeks<br>|
| Experimental: Fermented Codonopsis lanceolata 1050mg<br>Fermented Codonopsis lanceolata 1050mg/day | Dietary Supplement: Fermented Codonopsis lanceolata 1050mg<br>* Fermented Codonopsis lanceolata 1050mg daily for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |