Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
- Conditions
- Subjective Memory Complaints
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Fermented Codonopsis lanceolata 525mgDietary Supplement: Fermented Codonopsis lanceolata 1050mg
- Registration Number
- NCT03439098
- Lead Sponsor
- Ewha Womans University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age between 20 and 65 years old
- Global Deterioration Scale score (GDS) of 2
- High school or higher levels of education
- With informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Fermented Codonopsis lanceolata 525mg Fermented Codonopsis lanceolata 525mg Fermented Codonopsis lanceolata 525mg/day Fermented Codonopsis lanceolata 1050mg Fermented Codonopsis lanceolata 1050mg Fermented Codonopsis lanceolata 1050mg/day
- Primary Outcome Measures
Name Time Method Changes in standardized scores on a neuropsychological test battery baseline, 4th week, 8th week 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.
- Secondary Outcome Measures
Name Time Method Changes in scores of the Subjective Memory Complaints Questionnaire baseline, 4th week, 8th week 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.
Number of participants with adverse events 4th week, 8th week Changes of brain volume in magnetic resonance imaging assessed by computational approaches baseline, 8th week Volumes of the clusters in the brain are reported in cubic millimeters
Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches baseline, 8th week Cortical thickness is measured in millimeters.
Functional brain changes in magnetic resonance imaging assessed by computational approaches baseline, 8th week 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.
Metabolic brain changes in magnetic resonance imaging assessed by computational approaches baseline, 8th week Brain metabolite concentrations are assessed using the magnetic resonance spectroscopy and are estimated in mmol per liter.
Trial Locations
- Locations (1)
Ewha Womans University
🇰🇷Seoul, Korea, Republic of