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

Sponsor
Ewha Womans University (Other)
Overall Status
Completed
CT.gov ID
NCT03439098
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
10.4
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Fermented Codonopsis lanceolata 525mg
  • Dietary Supplement: Fermented Codonopsis lanceolata 1050mg
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 6, 2015
Actual Primary Completion Date :
May 19, 2016
Actual Study Completion Date :
May 19, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fermented Codonopsis lanceolata 525mg

Fermented Codonopsis lanceolata 525mg/day

Dietary Supplement: Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 525mg daily for 8 weeks
Experimental: Fermented Codonopsis lanceolata 1050mg

Fermented Codonopsis lanceolata 1050mg/day

Dietary Supplement: Fermented Codonopsis lanceolata 1050mg
Fermented Codonopsis lanceolata 1050mg daily for 8 weeks
Placebo Comparator: Placebo

Placebo

Dietary Supplement: Placebo
Placebo daily for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Number of participants with adverse events [4th week, 8th week]

  3. 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

  4. Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches [baseline, 8th week]

    Cortical thickness is measured in millimeters.

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ewha Womans University Seoul Korea, Republic of 03760

Sponsors and Collaborators

  • Ewha Womans University

Investigators

  • Principal Investigator: Inkyoon Lyoo, MD, PhD, MMS, Ewha Womans University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT03439098
Other Study ID Numbers:
  • EBI_CT_FCL
First Posted:
Feb 20, 2018
Last Update Posted:
Aug 14, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 14, 2019