Effect of Kimchi Intake on Body Fat in Overweight Subjects

NCT ID: NCT05898802

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2023-11-09

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.

Detailed Description

This is a randomized, double-blind, placebo-controlled clinical trial to investigate the anti-obesity effect of kimchi fermented with the addition of specific lactic acid bacteria.

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. Specifically, subjects with a BMI of between 23~30kg/m2 take 1,200 mg of traditional kimchi or starter kimchi capsules three times per day before each meal, for a total of 3,600 mg per day. As a control, subjects with a BMI of 23 to 30 kg/m2 take lactose capsules in a similar form and in the same amount. The total study period is 16 weeks of intake of kimchi capsules or placebo capsules, excluding the 2 weeks of preparation period for subject selection. Before and after taking the kimchi capsule or the placebo capsule, the following evaluation criteria of the subject will be measured; DEXA (Dual Energy X-ray Absorptiometry), BMI, Weight, Waist to Hip ratio (WHR), total cholesterol, triglyceride, HDL-C, calculate LDL-C, FFA, HbA1c, glucose, insulin, HOMA-IR, hs-CRP, Adiponectin, Leptin. Also, Changes in gut microbiome composition will be determined by measuring bacterial population levels in stool samples collected before and after taking kimchi capsules or placebo capsules.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Kimchi inoculated Leuconostoc mesenteroides

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

Group Type: EXPERIMENTAL

Kimchi

Intervention Type: DIETARY_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.

Kimchi

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

Group Type: EXPERIMENTAL

Kimchi

Intervention Type: DIETARY_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.

Lactose

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Lactose with kimchi flavor

Interventions

Kimchi

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Lactose with kimchi flavor

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Institute of Kimchi

OTHER_GOV

Sponsor Role: lead

Responsible Party

Woo Je Lee

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wooje Lee, ph.D

Role: PRINCIPAL_INVESTIGATOR

World Institute of Kimchi

Myungjun Shin, M.D., Ph.D.

Role: STUDY_CHAIR

Pusan National University Hospital

Locations

Pusan National University Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

WiKim_2210-037-119

Identifier Type: -

Identifier Source: org_study_id