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

NCT ID: NCT07321821

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-19

Study Completion Date

2026-01-21

Brief Summary

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"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

Detailed Description

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Conditions

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Mild Cognitive Impairment (MCI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
except for one assessor who will have access to group assignments

Study Groups

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Fermented Garlic Lettuce Powder

Participants receive fermented garlic lettuce powder, administered orally as three tablets per day for 2 months (total of 180 tablets).

Group Type EXPERIMENTAL

Garlic Lettuce Fermented Powder

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Tablet

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Garlic Lettuce Fermented Powder

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong-il Shin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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11-2024-061

Identifier Type: -

Identifier Source: org_study_id

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