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

Ewha Womans University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Subjective Memory Complaints

Interventions

Fermented Codonopsis lanceolata 525mgDIETARY_SUPPLEMENT

Fermented Codonopsis lanceolata 525mg daily for 8 weeks

Fermented Codonopsis lanceolata 1050mgDIETARY_SUPPLEMENT

Fermented Codonopsis lanceolata 1050mg daily for 8 weeks

PlaceboDIETARY_SUPPLEMENT

Placebo daily for 8 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ewha Womans University

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: baseline, 4th week, 8th week

Secondary Outcomes

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.

Time frame: baseline, 4th week, 8th week

Number of participants with adverse events

Time frame: 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

Time frame: baseline, 8th week

Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches

Cortical thickness is measured in millimeters.

Time frame: 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.

Data from ClinicalTrials.gov

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