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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377024
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Adults With Subjective Memory Complaints Dietary Supplement: TF 600mg Dietary Supplement: TF 1200mg Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions in Healthy Adults With Subjective Cognitive Impairment: An 8-Week Prospective Randomized Double-Blind Placebo-Controlled Trial With Multimodal Neuroimaging and Neurocognitive Assessments
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB) [ Time Frame: baseline, 8th week ]
    Scores from neurocognitive test batteries such as CANTAB

  2. Changes from baseline in brain structure analyzed using the computational approach [ Time Frame: baseline, 8th week ]
    Morphometric analysis of brain structures in magnetic resonance imaging

  3. Changes from baseline in brain function analyzed using the computational approach (Blood oxygenation level dependent (BOLD) signal intensity) [ Time Frame: baseline, 8 week ]
    Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans

  4. Changes from baseline in brain biochemical metabolism analyzed using the computational approach (Brain metabolite concentrations assessed using magnetic resonance spectroscopy) [ Time Frame: baseline, 8th week ]
    Brain metabolite concentrations assessed using magnetic resonance spectroscopy


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377024


Locations
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Korea, Republic of
Ewha Womans University
Seoul, Korea, Republic of, 120-750
Sponsors and Collaborators
Ewha Womans University
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Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT02377024    
Other Study ID Numbers: EBI_CT_TF
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015