Mild Cognitive Impairment (MCI)
Conditions
Keywords
Fermented Garlic Lettuce Powder, Mild Cognitive Impairment, Psychological Outcome, Randomized Controlled Trial
Brief summary
This study aims to investigate the cognitive and psychological changes in adults with mild cognitive impairment (K-MoCA scores between 16 and 23) following daily consumption of fermented garlic lettuce powder for 2 months
Interventions
DIETARY_SUPPLEMENTGarlic Lettuce Fermented Powder
The Garlic Lettuce Fermented Powder tablets (intervention group) are taken 3 tablets daily for 2 months, totaling 180 tablets
OTHERPlacebo
Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
except for one assessor who will have access to group assignments
Intervention model description
Participants with mild cognitive impairment (K-MoCA scores 16-23) will be randomly assigned to either the intervention group receiving fermented garlic lettuce powder daily for 2 months or to a control group. Cognitive and psychological outcomes will be assessed at baseline and at the end of the 2-month intervention. Outcome assessors will be blinded to group allocation, and the study will be conducted as a single-center, investigator-initiated, parallel-group, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 19 years or older with K-MoCA scores between 16 and 23. * Individuals with sufficient vision and hearing to participate in the study without difficulty. * Participants who are currently taking medications or receiving treatments that may affect cognition and are able to maintain the same dosage and regimen throughout the study period. * Individuals who voluntarily agree to participate in the study and provide written informed consent.
Exclusion criteria
* Individuals who have undergone vascular-related surgery within the past 6 months or gastrointestinal surgery that may affect absorption of the study product (excluding simple appendectomy or hernia repair). * Individuals with a clinically significant history of hypersensitivity to medications or dietary supplements. * Individuals with a history of alcohol or drug abuse. * Individuals unable to communicate effectively. * Individuals who have participated in more than two dietary supplement studies or clinical trials within the current year, or within the past 6 months. * Individuals deemed unable to participate safely or effectively in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| K-MoCA | Assessments are performed at baseline and at 2 months. | The Korean version of the Montreal Cognitive Assessment (K-MoCA) is a cognitive screening tool with scores ranging from 0 to 30, with higher scores indicating better cognitive function. The outcome measure is the change in K-MoCA score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KCWS | Assessments are performed at baseline and at 2 months. | The Korean Color-Word Stroop Test (KCWS) is a neuropsychological assessment used to evaluate executive function and cognitive control. Performance is measured by the number of correct responses within 1- and 2-minute intervals, with higher scores indicating better cognitive function. |
| RCFT | Assessments are performed at baseline and at 2 months. | The Rey Complex Figure Test (RCFT) is a neuropsychological assessment used to evaluate visuospatial constructional ability and visual memory. Scores range from 0 to 36, with higher scores indicating better memory performance. |
| DST | Assessments are performed at baseline and at 2 months. | The Digit Span Test (DST) is a neuropsychological assessment used to evaluate attention and working memory. Scores range from 0 to 24, with higher scores indicating better concentration and attention. |
| COWAT | Assessments are performed at baseline and at 2 months. | The Controlled Oral Word Association Test (COWAT) is a neuropsychological assessment used to evaluate verbal fluency and executive function. Scores range from 0 to 27, with higher scores indicating better verbal fluency, executive function, attention, and problem-solving abilities. |
| SVLT | Assessments are performed at baseline and at 2 months. | The Seoul Verbal Learning Test (SVLT) is a neuropsychological assessment tool used to evaluate verbal memory performance. Scores range from 0 to 36, with higher scores indicating better memory function. |
| EQ-5D | Assessments are performed at baseline and at 2 months. | The EuroQol-5 Dimension (EQ-5D) is a standardized instrument for measuring health-related quality of life. Scores range from 0 to 100, with lower scores indicating better perceived health status and higher scores reflecting more severe health problems. |
| MFS | Assessments are performed at baseline and at 2 months. | The Multidimensional Fatigue Scale (MFS) is a self-report questionnaire used to assess fatigue across multiple dimensions. Each dimension is rated from 0 to 20, with a total score ranging from 0 to 100. Lower scores indicate less fatigue, while higher scores reflect more severe fatigue. |
| PWI-SF | Assessments are performed at baseline and at 2 months. | The Psychological Well-Being Index-Short Form (PWI-SF) is a self-report questionnaire used to assess psychological well-being. Each dimension is rated from 0 to 20, with total scores ranging from 0 to 54, where higher scores indicate better psychological well-being, life satisfaction, and emotional stability. |
| LSEQ | Assessments are performed at baseline and at 2 months. | The Leeds Sleep Evaluation Questionnaire (LSEQ) is a self-report instrument used to assess subjective sleep quality. Scores are based on a scale from 0 to 100, with higher scores indicating better sleep quality and lower scores reflecting greater sleep disturbance. |
| BDI | Assessments are performed at baseline and at 2 months. | The Beck Depression Inventory (BDI) is a self-report questionnaire used to assess the severity of depressive symptoms. Each item is scored from 0 to 3, with total scores ranging from 0 to 63, where higher scores indicate more severe depressive symptoms. |
Countries
South Korea
Outcome results
None listed