A trial to evaluate the efficacy and safety of high temperature processed green tea extract on improvement of memory functio
- Conditions
- Not Applicable
- Registration Number
- KCT0003661
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
Those who are between the ages of 40 and 65 at the time of screening
- Those who complain subjective memory impairment (who answer yes at least 1 question at Subjective Memory Complaints Questionnaire[SMCQ], or score 2 at Global Deterioration Scale[GDS], and score 26 or more at Mini-Mental State Examination in the Korean version of the CERAD assessment packet[MMSE-KC])
- Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, generalized anxiety disorder, substance-related disorder) evaluated with a structured instrument
- Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests
- Neuropsychological tests indicate a suspected diagnosis of dementia
- A history of traumatic brain injury with loss of consciousness or convulsion
- Had taken psychotropic drugs within the past 1 month before screening
- Had taken a dietary supplement for improving memory and cognitive skills within the past 1 month before screening
- Had taken a dietary supplement made of green tea extract within the past 1 month before screening, or had consumed more than 4 cups of green tea a day
- Had experienced allergic reaction with ingredient including green tea
- Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding
- Participated in another clinical trial within the past 1 months before screening
- Any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in the body)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of attention, memory, executive functions and etc. at 12 weeks assessed by the neuropsychological test battery;Change of cognitive function and memory assessed by the Subjective Memory Complaints Questionnaire (SMCQ)
- Secondary Outcome Measures
Name Time Method Change of brain structure, function, and metabolism at 12 weeks assessed by computational analysis of magnetic resonance imaging data