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

August 12, 2019 updated by: In Kyoon Lyoo, Ewha Womans University

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo daily for 8 weeks
EXPERIMENTAL: Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 525mg/day
Fermented Codonopsis lanceolata 525mg daily for 8 weeks
EXPERIMENTAL: Fermented Codonopsis lanceolata 1050mg
Fermented Codonopsis lanceolata 1050mg/day
Fermented Codonopsis lanceolata 1050mg daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in standardized scores on a neuropsychological test battery
Time Frame: 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.
baseline, 4th week, 8th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in scores of the Subjective Memory Complaints Questionnaire
Time Frame: 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.
baseline, 4th week, 8th week
Number of participants with adverse events
Time Frame: 4th week, 8th week
4th week, 8th week
Changes of brain volume in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline, 8th week
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
Time Frame: baseline, 8th week
Cortical thickness is measured in millimeters.
baseline, 8th week
Functional brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame: 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.
baseline, 8th week
Metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline, 8th week
Brain metabolite concentrations are assessed using the magnetic resonance spectroscopy and are estimated in mmol per liter.
baseline, 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2015

Primary Completion (ACTUAL)

May 19, 2016

Study Completion (ACTUAL)

May 19, 2016

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

February 13, 2018

First Posted (ACTUAL)

February 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • EBI_CT_FCL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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