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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults With Subjective Memory Complaints
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: TF 600mg; Dietary supplement: TF 1200mg

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: placebo
Experimental: TF 600mg; TF 600mg/day	Dietary supplement: TF 600mg
Experimental: TF 1200mg; TF 1200mg/day	Dietary supplement: TF 1200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB)	Scores from neurocognitive test batteries such as CANTAB	baseline, 8th week
Changes from baseline in brain structure analyzed using the computational approach	Morphometric analysis of brain structures in magnetic resonance imaging	baseline, 8th week
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	baseline, 8 week
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	baseline, 8th week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks	baseline, 8th week
Number of participants with adverse events	4th week
Number of participants with adverse events	8th week

Collaborators and Investigators

• Sponsor: Ewha Womans University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: EBI_CT_TF