NCT07321821

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 23, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

Fermented Garlic Lettuce PowderMild Cognitive ImpairmentPsychological OutcomeRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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.

  • +5 more secondary outcomes

Study Arms (2)

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).

Dietary Supplement: Garlic Lettuce Fermented Powder

Placebo Tablet

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

The Garlic Lettuce Fermented Powder tablets (intervention group) are taken 3 tablets daily for 2 months, totaling 180 tablets

Fermented Garlic Lettuce Powder
PlaceboOTHER

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

Placebo Tablet

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
except for one assessor who will have access to group assignments
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 7, 2026

Study Start

September 19, 2025

Primary Completion

January 21, 2026

Study Completion

January 21, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations