Effect of Kimchi Intake on Body Fat in Overweight Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Kimchi Intake on Body Fat in Overweight Subjects: A Randomized, Double-blind, Placebo-Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Kimchi
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kimchi inoculated Leuconostoc mesenteroides<br>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<br>* 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.<br>|
| Experimental: Kimchi<br>3,600mg/day containing 80% Kimchi powder (3 tablets 3 times per day after meals over the 16-week regimen) | Dietary Supplement: Kimchi<br>* 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.<br>|
| Placebo Comparator: Lactose<br>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<br>* Lactose with kimchi flavor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass change in 16-week | Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry) | 8 weeks, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body mass index (BMI) |  | 8 weeks, 16 weeks | 
| Changes in body weight |  | 8 weeks, 16 weeks | 
| Changes in waist to hip ratio (WHR) |  | 8 weeks, 16 weeks | 
| Changes in Body fat ratio (%) | Body fat ratio (%) will be assessed by DEXA | 8 weeks, 16 weeks | 
| Changes in Body lean mass (kg) | Body lean mass (kg) will be assessed by DEXA | 8 weeks, 16 weeks | 
| Changes in serum lipid profile (Total cholesterol, Triglycerides，Low-density lipoprotein，High density lipoprotein) |  | 8 weeks, 16 weeks | 
| Changes in free fatty acids (FFA) concentration |  | 8 weeks, 16 weeks | 
| Changes in HbA1c |  | 8 weeks, 16 weeks | 
| Changes in fasting glucose concentration |  | 8 weeks, 16 weeks | 
| Changes in insulin resistance |  | 8 weeks, 16 weeks | 
| Changes in HOMA-IR value | HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance | 8 weeks, 16 weeks | 
| Changes of serum hs-CRP |  | 8 weeks, 16 weeks | 
| Changes in adiponection |  | 8 weeks, 16 weeks | 
| Changes in leptin |  | 8 weeks, 16 weeks | 
| Change of Microbiota composite |  | 8 weeks, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kimchi, Lactic acid bacteria