Cognitive Function
Conditions
Brief summary
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.
Interventions
DIETARY_SUPPLEMENTEriobotyra Japonica Lindley Extract
Eriobotyra Japonica Lindley Extract (1.5g/day)
DIETARY_SUPPLEMENTPlacebo
Placebo (1.5g/day)
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females 16-19 years old * Weight within ±30% of ideal body weight * Able to give informed consent
Exclusion criteria
* Allergic or hypersensitive to any of the ingredients in the test products * History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery * History of alcohol or substance abuse * Participation in any other clinical trials within past 2 months * Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * Pregnant or lactating women etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in K-MMSE(Korean Mini-Mental State Examination) | 12 weeks | K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Rey-Kim Memory Test | 12 weeks | Rey-Kim Memory Test was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in BCRS(Brief Cognitive Rating Scale) | 12 weeks | BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in PRMQ(Prospective and retrospective memory questionnaire) | 12 weeks | PRMQ(Prospective and retrospective memory questionnaire) was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in STAI(State-trait anxiety inventory) | 12 weeks | STAI(State-trait anxiety inventory) was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in BDNF(Brain derived neurotrophic factor) | 12 weeks | BDNF(Brain derived neurotrophic factor) was measured in study visit 1(0 week) and visit 3(12 week). |
Countries
South Korea
Outcome results
None listed