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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
90
Pusan National University Hospital
Busan, South Korea
Fat mass change in 12-week
Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)
Time frame: Baseline (Visit 2, Day 0) and Week 12 (Visit 4, Day 84 ±7)
Changes in body mass index (BMI)
BMI will be calculated as weight (kg) divided by height squared (m²) at baseline, week 6, and week 12.
Time frame: Baseline, Week 6, Week 12
Changes in body weight
Body weight will be measured using a calibrated digital scale at baseline, week 6, and week 12.
Time frame: Baseline, Week 6, Week 12
Changes in waist to hip ratio (WHR)
Waist to hip ratio will be calculated by dividing waist circumference by hip circumference at baseline, week 6, and week 12.
Time frame: Baseline, Week 6, Week 12
Changes in Body fat ratio (%)
Body fat ratio (%) will be assessed by DEXA
Time frame: Baseline and Week 12
Changes in Body lean mass (kg)
Body lean mass (kg) will be assessed by DEXA
Time frame: Baseline and Week 12
Changes in serum lipid profile (Total cholesterol, Triglycerides,Low-density lipoprotein,High density lipoprotein)
Fasting blood samples will be collected to measure total cholesterol, triglycerides, LDL-C, and HDL-C at baseline and week 12
Time frame: Baseline and Week 12
Changes in free fatty acids (FFA) concentration
Serum free fatty acid concentration will be measured at baseline and week 12.
Time frame: Baseline and Week 12
Changes in HbA1c
HbA1c levels will be measured at baseline and week 12 to assess glycemic control.
Time frame: Baseline and Week 12
Changes in fasting glucose concentration
Fasting blood glucose concentration will be measured at baseline and week 12.
Time frame: Baseline and Week 12
Changes in insulin resistance
Insulin resistance will be assessed using fasting insulin and glucose values at baseline and week 12.
Time frame: Baseline and Week 12
Changes in HOMA-IR value
HOMA-IR will be calculated as \[fasting insulin (μIU/mL) x fasting glucose (mg/dL)\] / 405 at baseline and week 12.
Time frame: Baseline and Week 12
Changes of serum hs-CRP
High sensitivity C-reactive protein will be measured at baseline and week 12.
Time frame: Baseline and Week 12
Changes in adiponection
Serum adiponectin levels will be measured at baseline and week 12.
Time frame: Baseline and Week 12
Changes in leptin
Serum leptin levels will be measured at baseline and week 12.
Time frame: Baseline and Week 12
Change of Microbiota composite
Fecal microbiota composition will be assessed at baseline and week 12 using 16S rRNA sequencing.
Time frame: Baseline and Week 12
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