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

NCT02377024 | Completed

• 1 other identifier: EBI_CT_TF
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults With Subjective Memory Complaints

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (3)

TF 600mg

EXPERIMENTAL

TF 600mg/day

Dietary Supplement: TF 600mg

TF 1200mg

EXPERIMENTAL

TF 1200mg/day

Dietary Supplement: TF 1200mg

placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: placebo

Interventions

TF 600mg DIETARY_SUPPLEMENT

TF 600mg

TF 1200mg DIETARY_SUPPLEMENT

TF 1200mg

placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha Womans University

Seoul, 120-750, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 3, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

KR (1)