Cognitive Function
Conditions
Keywords
Hydrolysed Red Ginseng Extract, Cognitive Function
Brief summary
This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function
Detailed description
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 100 subjects participated in hydrolysed red ginseng extract or placebo group. To evaluate the changes in the evaluation items when hydrolysed red ginseng extract was taken 12 weeks compared with placebo.
Interventions
DIETARY_SUPPLEMENTHydrolysed Red Ginseng Extract
once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 1g/day) for 12 week
DIETARY_SUPPLEMENTPlacebo
once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 0g/day) for 12 week
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Persons who are at least 60 years of age at screening * Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points * Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
Exclusion criteria
* Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years * Patients with BMI(Body Mass Index)\<18.5 kg/m\^ or 35 kg/m\^≤BMI(Body Mass Index) * Patients with alcohol abuse or dependence within the last 3 months * Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.) * Patients with a history of clinically significant hypersensitivity to ginseng or red ginseng * Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening * Patients who ingested ginseng and red ginseng extract's health functional food within 1 month before screening * Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks * Patients who participate in another human trial within 3 months * Those who show the following results in the Laboratory test * AST, ALT \> 3 times upper limit of the normal range * Other significant laboratory test opinion * Patients who are deemed unsuitable for participating in the human trial due to other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual learning test | 12 weeks | Visual learning test was measured in baseline and 12 week. |
| Visual working memory test | 12 weeks | Visual working memory test was measured in baseline and 12 week. |
| MoCA-K; Korean Version of the Montreal Cognitive Assessment | 12 weeks | Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation. Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BDI; Beck Depression Inventory | 12 weeks | Beck Depression Inventory(BDI) was measured in baseline and 12 week. It consists of 21 items including cognitive, emotional, synchronous, and physical symptoms of depression. The total score ranges from 0\ 63 points for each question. Beck Depression Inventory(BDI) score is 0 \ 9 points non-depression, 10 \ 15 is mild depression, 16 \ 23 is moderate depression, and 24 \ 63 is severe depression. |
| Auditory continuous performance test | 12 weeks | Auditory continuous performance test was measured in baseline and 12 week. |
| TAS(Total antioxidant status) | 12 weeks | Total antioxidant status(TAS) was measured in baseline and 12 week. |
| BDNF; Brain-derived neurotrophic factor | 12 weeks | Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week. |
| Verbal learning test | 12 weeks | Verbal learning test was measured in baseline and 12 week. |
| PSS; Perceived stress scale | 12 weeks | Perceived stress scale(PSS) was measured in baseline and 12 week. It consists of 10 questions. Each question is evaluated from 0 (none) to 4 (very often), and 4 items (4, 5, 7, 8) are scored back and added to the remaining questions. The duration of the last month should be presented before implementation (if the duration is longer, the predictability is lowered). |
Countries
South Korea
Outcome results
None listed