A trial to evaluate the efficacy and safety of high temperature processed green tea extract on improvement of memory function

A 12-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of high temperature processed green tea extract on improvement of memory function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003661

Enrollment

Registered

2019-03-25

Start date

2019-03-25

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : High temperature processed green tea extract or placebo 2 tablets (500mg per tablet) per day, twice a day for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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])

Exclusion criteria

Exclusion criteria: - 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change of brain structure, function, and metabolism at 12 weeks assessed by computational analysis of magnetic resonance imaging data	—

Countries

Korea, Republic of

Contacts

Public ContactSujung Yoon

Ewha Womans University

sujungjyoon@gmail.com+82-2-3277-6560

Outcome results