None listed
Conditions
Interventions
Dietary Supplement : One tablet was orally administered once daily for 12 weeks.
- Test: One tablet once daily (equivalent to 450 mg/day of Moringa–Perilla Extract Complex).
- Placebo: One tablet onc
Sponsors
Cosmax Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male or female adults aged 50 to 70 years (inclusive) at the time of screening who complain of memory decline (2) Individuals whose scores on the CERAD-K Word List Memory, Word List Recall, or Word List Recognition tests are 1 to 1.5 standard deviations (SD) below the normative mean (must meet at least one of these three criteria) (3) Individuals with a total score of 22 or lower on the Korean version of the Montreal Cognitive Assessment (MoCA-K) (4) Individuals who have received a detailed explanation of the clinical trial, fully understood it, voluntarily decided to participate, and provided written informed consent agreeing to comply with all precautions and instructions
Exclusion criteria
Exclusion criteria: (1) Subjects with a history of alcohol abuse or dependence within 3 months prior to the screening visit. (2) Subjects who are currently receiving treatment for major depressive disorder, have received treatment for major depressive disorder within the past 3 years, or have a Beck Depression Inventory-II (BDI-II) score =16. (3) Subjects with diseases associated with cognitive impairment, such as dementia, Parkinson’s disease, or cerebral infarction. (4) Subjects who meet the clinical diagnostic criteria for Attention-Deficit/Hyperactivity Disorder (ADHD). (5) Subjects who are unable to read and understand Korean. (6) Subjects with known hypersensitivity to any component of the investigational product. (7) Subjects with clinically significant acute or chronic diseases requiring treatment, including but not limited to disorders of the cardiovascular/cerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory, hematologic/neoplastic, or gastrointestinal systems. (8) Subjects who have taken medications, health functional foods, or herbal medicines related to cognitive function or memory improvement within 1 month prior to screening (refer to the prohibited concomitant medications list). (9) Subjects who have taken psychotropic medications, including antipsychotics, antidepressants, mood stabilizers, hypnotics, or anxiolytics, within 1 month prior to screening. (10) Subjects who have donated whole blood within 1 month or undergone component blood donation within 2 weeks prior to screening. (11) Subjects who have participated in another human clinical trial within 3 months prior to screening. (12) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period. (13) Subjects with any of the following laboratory findings at screening: ? AST or ALT > 3 × the upper limit of normal (ULN) ? Serum creatinine > 2.0 mg/dL (14) Subjects deemed unsuitable for participation in the study by the Investigator based on laboratory test results or any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Korean Version of Montreal Cognitive Assessment (MoCA-K);Verbal learning test;Digit Span Test;Visual Span Test | — |
Secondary
| Measure | Time frame |
|---|---|
| Brain-derived neurotrophic factor(BDNF);Amyloid-ß;Acetylcholinesterase(AchE);Glutathione peroxidase(GPx) | — |
Countries
Korea, Republic of
Contacts
Public ContactSiyeon Lee
Jeonbuk National University Hospital
Outcome results
None listed