Mild Cognitive Impairment (MCI)NCT07321821
Fermented Garlic Lettuce Powder and Cognitive Function in Adults With Mild Cognitive Impairment
A study testing Garlic Lettuce Fermented Powder in people with Mild Cognitive Impairment (MCI), run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Garlic Lettuce Fermented Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2025to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do
About this study
Official 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
"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
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Garlic Lettuce Fermented Powder, Placebo
- Keywords
- Fermented Garlic Lettuce Powder, Mild Cognitive Impairment, Psychological Outcome, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic Lettuce Fermented PowderDietary supplement
The Garlic Lettuce Fermented Powder tablets (intervention group) are taken 3 tablets daily for 2 months, totaling 180 tablets
PlaceboOther
Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Garlic Lettuce Fermented Powder |
| Placebo Tablet | Placebo comparator | Participants take 1 placebo tablet daily for 2 months, totaling 60 tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessments are performed at baseline and at 2 months.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessments are performed at baseline and at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start19 Sep 2025
- Primary completion21 Jan 2026 (estimated)
- Study completion21 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321821
- Sponsor's protocol ID
- 11-2024-061
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07321821
- Acronym / sponsor ID
- 11-2024-061
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Fermented Garlic Lettuce Powder, Mild Cognitive Impairment, Psychological Outcome, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 21 Jan 2026 (estimated)
- Study completion
- 21 Jan 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fermented Garlic Lettuce Powder | Experimental | Dietary Supplement: Garlic Lettuce Fermented PowderParticipants receive fermented garlic lettuce powder, administered orally as three tablets per day for 2 months (total of 180 tablets). |
| Placebo Tablet | Placebo comparator | Other: PlaceboParticipants take 1 placebo tablet daily for 2 months, totaling 60 tablets |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garlic Lettuce Fermented PowderThe Garlic Lettuce Fermented Powder tablets (intervention group) are taken 3 tablets daily for 2 months, totaling 180 tablets | Dietary supplement | Fermented Garlic Lettuce Powder |
| PlaceboParticipants take 1 placebo tablet daily for 2 months, totaling 60 tablets | Other | Placebo Tablet |
Primary outcome
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.
10 secondary outcomes
SVLT
Time frame: Assessments are performed at baseline and at 2 months.
KCWS
Time frame: Assessments are performed at baseline and at 2 months.
RCFT
Time frame: Assessments are performed at baseline and at 2 months.
DST
Time frame: Assessments are performed at baseline and at 2 months.
COWAT
Time frame: Assessments are performed at baseline and at 2 months.
BDI
Time frame: Assessments are performed at baseline and at 2 months.
EQ-5D
Time frame: Assessments are performed at baseline and at 2 months.
MFS
Time frame: Assessments are performed at baseline and at 2 months.
PWI-SF
Time frame: Assessments are performed at baseline and at 2 months.
LSEQ
Time frame: Assessments are performed at baseline and at 2 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic Lettuce Fermented Powder in people with Mild Cognitive Impairment (MCI), run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-MoCA (time frame: Assessments are performed at baseline and at 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.