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"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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented Garlic Lettuce Powder | Experimental | Participants receive fermented garlic lettuce powder, administered orally as three tablets per day for 2 months (total of 180 tablets). |
|
| Placebo Tablet | Placebo Comparator | Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garlic Lettuce Fermented Powder | Dietary Supplement | The Garlic Lettuce Fermented Powder tablets (intervention group) are taken 3 tablets daily for 2 months, totaling 180 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| K-MoCA | 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. | Assessments are performed at baseline and at 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| SVLT | 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. | Assessments are performed at baseline and at 2 months. |
| KCWS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | South Korea |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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.
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except for one assessor who will have access to group assignments
| Placebo | Other | Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets |
|
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. |
| Assessments are performed at baseline and at 2 months. |
| RCFT | 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. | Assessments are performed at baseline and at 2 months. |
| DST | 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. | Assessments are performed at baseline and at 2 months. |
| COWAT | 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. | Assessments are performed at baseline and at 2 months. |
| BDI | 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. | Assessments are performed at baseline and at 2 months. |
| EQ-5D | 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. | Assessments are performed at baseline and at 2 months. |
| MFS | 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. | Assessments are performed at baseline and at 2 months. |
| PWI-SF | 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. | Assessments are performed at baseline and at 2 months. |
| LSEQ | 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. | Assessments are performed at baseline and at 2 months. |