Fermented Garlic Lettuce Powder and Cognitive Function in Adults With Mild Cognitive Impairment

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

"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 Overview

• Status: Active, not recruiting
• Conditions: Mild Cognitive Impairment (MCI)
• Intervention / Treatment: Dietary supplement: Garlic Lettuce Fermented Powder; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, South Korea
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fermented Garlic Lettuce Powder; Participants receive fermented garlic lettuce powder, administered orally as three tablets per day for 2 months (total of 180 tablets).	Dietary supplement: Garlic Lettuce Fermented Powder; The Garlic Lettuce Fermented Powder tablets (intervention group) are taken 3 tablets daily for 2 months, totaling 180 tablets
Placebo Comparator: Placebo Tablet; Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets	Other: Placebo; Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2025
• Primary Completion (Estimated): January 21, 2026
• Study Completion (Estimated): January 21, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Randomized Controlled Trial; Psychological Outcome; Fermented Garlic Lettuce Powder
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 11-2024-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No