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

Not Applicable

Completed

• Conditions: Healthy Adults With Subjective Memory Complaints
• Interventions: Dietary Supplement: TF 1200mg; Dietary Supplement: TF 600mg; Dietary Supplement: placebo

• Registration Number: NCT02377024
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TF 1200mg	TF 1200mg	TF 1200mg/day
TF 600mg	TF 600mg	TF 600mg/day
placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB)	baseline, 8th week	Scores from neurocognitive test batteries such as CANTAB
Changes from baseline in brain function analyzed using the computational approach (Blood oxygenation level dependent (BOLD) signal intensity)	baseline, 8 week	Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans
Changes from baseline in brain biochemical metabolism analyzed using the computational approach (Brain metabolite concentrations assessed using magnetic resonance spectroscopy)	baseline, 8th week	Brain metabolite concentrations assessed using magnetic resonance spectroscopy
Changes from baseline in brain structure analyzed using the computational approach	baseline, 8th week	Morphometric analysis of brain structures in magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks	baseline, 8th week
Number of participants with adverse events	8th week

Trial Locations

Locations (1)

Ewha Womans University; 🇰🇷 Seoul, Korea, Republic of