Effect of Kimchi Intake on Body Fat in Overweight Subjects: A Randomized, Double-blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Fat mass change in 12-week
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants or study staff working with them will not know what supplements they are receiving.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fat mass change in 12-week
时间窗: Baseline (Visit 2, Day 0) and Week 12 (Visit 4, Day 84 ±7)
Fat mass is measured by DEXA(Dual Energy X-Ray Absorptiometry)
次要结局
- Changes in body weight(Baseline, Week 6, Week 12)
- Changes in body mass index (BMI)(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)
- Changes in serum lipid profile (Total cholesterol, Triglycerides，Low-density lipoprotein，High density lipoprotein)(Baseline and Week 12)
- Changes in free fatty acids (FFA) concentration(Baseline and Week 12)
- Changes in HbA1c(Baseline and Week 12)
- Changes in fasting glucose concentration(Baseline and Week 12)
- Changes in insulin resistance(Baseline and Week 12)
- Changes in HOMA-IR value(Baseline and Week 12)
- Changes of serum hs-CRP(Baseline and Week 12)
- Changes in adiponection(Baseline and Week 12)
- Changes in leptin(Baseline and Week 12)
- Change of Microbiota composite(Baseline and Week 12)
研究者
Woo Je Lee
Senior Researcher
World Institute of Kimchi