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Completed

NCT Number: NCT03439098

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

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.

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Key information

Conditions

Subjective Memory Complaints

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University

Seoul, 03760, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented Codonopsis lanceolata 525mg

Dietary Supplement

Fermented Codonopsis lanceolata 525mg daily for 8 weeks

Fermented Codonopsis lanceolata 1050mg

Dietary Supplement

Fermented Codonopsis lanceolata 1050mg daily for 8 weeks

Placebo

Dietary Supplement

Placebo daily for 8 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Number of participants with adverse events

    Time frame: 4th week, 8th week

  3. 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

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

    Time frame: baseline, 8th week

    Cortical thickness is measured in millimeters.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2018
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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