The Effect of Fermented Garlic Lettuce Powder on Cognitive Function in Adults With Mild Cognitive Impairment: An Investigator-Initiated, Randomized, Assessor-Blinded, Parallel-Group, Controlled, Single-Center Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- K-MoCA
Study Overview
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
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 19 years or older with K-MoCA scores between 16 and
- •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.
Arms & Interventions
Fermented Garlic Lettuce Powder
Participants receive fermented garlic lettuce powder, administered orally as three tablets per day for 2 months (total of 180 tablets).
Intervention: Garlic Lettuce Fermented Powder (Dietary Supplement)
Placebo Tablet
Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
K-MoCA
Time Frame: 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 Outcomes
- SVLT(Assessments are performed at baseline and at 2 months.)
- KCWS(Assessments are performed at baseline and at 2 months.)
- RCFT(Assessments are performed at baseline and at 2 months.)
- DST(Assessments are performed at baseline and at 2 months.)
- COWAT(Assessments are performed at baseline and at 2 months.)
- BDI(Assessments are performed at baseline and at 2 months.)
- EQ-5D(Assessments are performed at baseline and at 2 months.)
- MFS(Assessments are performed at baseline and at 2 months.)
- PWI-SF(Assessments are performed at baseline and at 2 months.)
- LSEQ(Assessments are performed at baseline and at 2 months.)
Investigators
Yong-il Shin
Professor
Pusan National University Yangsan Hospital