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NCT Number: NCT07321821

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

"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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Other

Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets

Primary outcomes

  1. 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

  1. SVLT

    Time frame: 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.

  2. KCWS

    Time frame: 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.

  3. RCFT

    Time frame: 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.

  4. DST

    Time frame: 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.

  5. COWAT

    Time frame: 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.

  6. BDI

    Time frame: 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.

  7. EQ-5D

    Time frame: 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.

  8. MFS

    Time frame: 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.

  9. PWI-SF

    Time frame: 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.

  10. LSEQ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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