NCT05898802

Brief Summary

Kimchi, a traditional Korean food, is prepared through the fermentation of various ingredients. It has been reported that kimchi contains beneficial nutrients from its raw materials, as well as lactic acid bacteria (LAB) and their byproducts produced during fermentation. LAB play an important role in the fermentation process, during which the dominant LAB species emerge and undergo a transition process. Depending on the species and strain of LAB, it has specific functions such as promoting weight loss, reducing inflammation, and lowering cholesterol levels. In this study, the effects of kimchi produced from traditional recipe or kimchi fermented with lactic acid bacteria, which have anti-obesity effects, on body composition changes and metabolic disease index will be investigated in subjects with a BMI of between 23\~30kg / m2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2023

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

June 2, 2023

Last Update Submit

July 5, 2025

Conditions

Keywords

KimchiLactic acid bacteria

Outcome Measures

Primary Outcomes (1)

  • Fat mass change in 12-week

    Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)

    Baseline (Visit 2, Day 0) and Week 12 (Visit 4, Day 84 ±7)

Secondary Outcomes (15)

  • Changes in body mass index (BMI)

    Baseline, Week 6, Week 12

  • Changes in body weight

    Baseline, Week 6, Week 12

  • Changes in waist to hip ratio (WHR)

    Baseline, Week 6, Week 12

  • Changes in Body fat ratio (%)

    Baseline and Week 12

  • Changes in Body lean mass (kg)

    Baseline and Week 12

  • +10 more secondary outcomes

Study Arms (3)

Kimchi inoculated Leuconostoc mesenteroides

EXPERIMENTAL

3,600mg/day containing 80% Kimchi inoculated Leuconostoc mesenteroides powder (3 tablets 3 times per day after meals over the 16-week regimen)

Dietary Supplement: Kimchi

Kimchi

EXPERIMENTAL

3,600mg/day containing 80% Kimchi powder (3 tablets 3 times per day after meals over the 16-week regimen)

Dietary Supplement: Kimchi

Lactose

PLACEBO COMPARATOR

3,600mg/day containing lactose placebo capsules to look identical. (3 tablets 3 times per day after meals over the 16-week regimen)

Dietary Supplement: Placebo

Interventions

KimchiDIETARY_SUPPLEMENT

Two different kimchi, one traditional kimchi and one fermented with a lactic acid bacteria having anti-obesity effect, hereafter starter kimchi, are flash freeze dried, powdered and encapsulated.

KimchiKimchi inoculated Leuconostoc mesenteroides
PlaceboDIETARY_SUPPLEMENT

Lactose with kimchi flavor

Lactose

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to consent to study participation and to comply with study requirements
  • Male and female subjects, 20-65 years of age
  • BMI of 23-30 kg/m2
  • Those who agreed not to consume Kimchi during the clinical study

You may not qualify if:

  • Patients with crucial cerebrovascular disease (cerebral infarction, cerebral hemorrhage etc.), or heart failure (angina pectoris, myocardial infarction, heart failure, arrhythmia etc.) or malignancy within 6 months
  • Uncontrolled hypertension (Elevated blood pressure (\>160/\>100))
  • Thyroid function test abnormality
  • Patients with significantly impaired kidney function: serume creatinine levels ≥2 times upper limit of normal
  • Patients with significantly impaired liver function: ALT or AST≥3 times upper limit of normal
  • Irregular or occasional gastrointestinal disorders (heartburn, indigestion, etc.)
  • Having taken drugs with a known influence on weight in the previous 1 month, such as diet pills, anti-depression drugs, beta-blockers, diuretic, contraceptives, corticosteroids, or female hormones
  • Participation in other dietary programmes or services within 3 months
  • Participation in other clinical trials within the past 1 month
  • Alcohol abuse
  • Quitted smoking within 3 months
  • Pregnancy or lactation or planning on becoming pregnant
  • Have a Kimchi allergy
  • Those who are judged unsuitable by the researcher for other reasons
  • Taking probiotics within 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Hospital

Busan, 49241, South Korea

Location

Related Publications (1)

  • Lee W, Moon HR, Choi H, Lee HJ, Kim Y, Kim HJ, Yun YR, Kwon MS, Hong SW. Single-cell RNA sequencing reveals that kimchi dietary intervention modulates human antigen-presenting and CD4(+) T cells. NPJ Sci Food. 2025 Nov 17;9(1):236. doi: 10.1038/s41538-025-00593-7.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wooje Lee, ph.D

    World Institute of Kimchi

    PRINCIPAL INVESTIGATOR
  • Myungjun Shin, M.D., Ph.D.

    Pusan National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants or study staff working with them will not know what supplements they are receiving.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

July 21, 2023

Primary Completion

November 9, 2023

Study Completion

November 9, 2023

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations