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CompletedNCT02377024Updated Jul 1, 2015

Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions

An interventional study of TF 600mg and TF 1200mg in Healthy Adults With Subjective Memory Complaints, sponsored by Ewha Womans University. Completed at 1 site in Korea, Republic of. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-07-01.

Sponsored by Ewha Womans University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

The objective of this study is to demonstrate the cognitive enhancement effect and safety of Tremella Fuciformis, 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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Conditions studied

  • Healthy Adults With Subjective Memory Complaints
03

In context

Lead sponsor

Ewha Womans University is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 40 and 65 years old
  • Global Deterioration Scale score (GDS) of 2
  • High school or higher levels of education.

Exclusion criteria

Exclusion Criteria:

  • Current pregnancy or breast-feeding
  • 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 24 or less
  • Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
  • Intelligence quotient less than 70
  • Contraindications to magnetic resonance imaging (MRI)
  • Use of psychotropics in last 3 months
  • Use of oral contraceptive medication
  • Participation in other clinical trials during the study period that might affect the outcome of the present study
  • Allergic adverse reactions to mushrooms
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    TF 600mg

    TF 600mg/day

    Dietary Supplement: TF 600mg

  • Experimental
    TF 1200mg

    TF 1200mg/day

    Dietary Supplement: TF 1200mg

  • Placebo comparator
    placebo

    placebo

    Dietary Supplement: placebo

Interventions

  • Dietary supplementTF 600mg
  • Dietary supplementTF 1200mg
  • Dietary supplementplacebo
06

What researchers measure

Primary outcomes

  1. Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB)

    Scores from neurocognitive test batteries such as CANTAB

    Time frame: baseline, 8th week

  2. Changes from baseline in brain structure analyzed using the computational approach

    Morphometric analysis of brain structures in magnetic resonance imaging

    Time frame: baseline, 8th week

  3. Changes from baseline in brain function analyzed using the computational approach (Blood oxygenation level dependent (BOLD) signal intensity)

    Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans

    Time frame: baseline, 8 week

  4. Changes from baseline in brain biochemical metabolism analyzed using the computational approach (Brain metabolite concentrations assessed using magnetic resonance spectroscopy)

    Brain metabolite concentrations assessed using magnetic resonance spectroscopy

    Time frame: baseline, 8th week

Secondary outcomes

  1. Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks

    Time frame: baseline, 8th week

  2. Number of participants with adverse events

    Time frame: 4th week

  3. Number of participants with adverse events

    Time frame: 8th week

07

Study locations

1 site
  • Ewha Womans University
    Seoul, 120-750, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02377024
Lead sponsor
Ewha Womans University
Responsible party
In Kyoon Lyoo (Professor, Ewha Womans University) — Principal investigator
First posted
Mar 3, 2015
Start date
Feb 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 1, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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