Clinical trial NCT05898802: Effect of Kimchi Intake on Body Fat in Overweight Subjects
Official title: Effect of Kimchi Intake on Body Fat in Overweight Subjects: A Randomized, Double-blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Kimchi
Lactic acid bacteria
Lead sponsor: World Institute of Kimchi
Sponsor class: OTHER_GOV
First posted: 2023-06-12
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Fat mass change in 16-week
timeFrame: 8 weeks, 16 weeks
Secondary outcomes:
measure: Changes in body mass index (BMI)
timeFrame: 8 weeks, 16 weeks
measure: Changes in body weight
timeFrame: 8 weeks, 16 weeks
measure: Changes in waist to hip ratio (WHR)
timeFrame: 8 weeks, 16 weeks
measure: Changes in Body fat ratio (%)
timeFrame: 8 weeks, 16 weeks
measure: Changes in Body lean mass (kg)
timeFrame: 8 weeks, 16 weeks
measure: Changes in serum lipid profile (Total cholesterol, Triglycerides，Low-density lipoprotein，High density lipoprotein)
timeFrame: 8 weeks, 16 weeks
measure: Changes in free fatty acids (FFA) concentration
timeFrame: 8 weeks, 16 weeks
measure: Changes in HbA1c
timeFrame: 8 weeks, 16 weeks
measure: Changes in fasting glucose concentration
timeFrame: 8 weeks, 16 weeks
measure: Changes in insulin resistance
timeFrame: 8 weeks, 16 weeks
measure: Changes in HOMA-IR value
timeFrame: 8 weeks, 16 weeks
measure: Changes of serum hs-CRP
timeFrame: 8 weeks, 16 weeks
measure: Changes in adiponection
timeFrame: 8 weeks, 16 weeks
measure: Changes in leptin
timeFrame: 8 weeks, 16 weeks
measure: Change of Microbiota composite
timeFrame: 8 weeks, 16 weeks
Other outcomes:
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