Evaluation of the Effects of a Probiotic Strain Lactobacillus Paracasei K56 on Body Fat Reduction in Middle-aged Obese Subjects：A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- visceral fat area (cm^2)
研究概览
简要总结
The aim of the present study was to investigate the effect of intervention with Lactobacillus paracasei K56 on body fat, metabolic risk markers,inflammatory markers and gut microbiota composition in obesity.
详细描述
Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.
In this randomised,double blind ,placebo controlled study, the participants were randomly assigned to probiotic K56 group or placebo group to evaluate the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing probiotic 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
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity : BMI>=30kg/m2,or percent body fat(PBF) >=25% for male, >=30% for female.
- •（Note: If PBF was eligible, it was recommended that 26 ≤ BMI ≤ 40）
- •Age: 40 - 65 years old adults
- •Who has the conditions to preserve the test samples at low temperature throughout the whole process
排除标准
- •Patients with severe chronic diseases（heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental illness and organ surgery history, etc.) and complications;
- •Patients with severe allergy and immunodeficiency;
- •Patients with a clear history of gastrointestinal diseases (ulcer, irritable bowel syndrome, etc.);
- •History of intervention with fat-reducing drugs or health products in the past 2 months
- •Take weight control measures (diet, exercise, etc.) within the past month
- •Participation in other clinical trials within the past 3 months
- •who have used antibiotics in the past 2weeks ;
- •Those who cannot guarantee to maintain their current lifestyle during the trial period
- •Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy
研究组 & 干预措施
placebo
placebo capsule(maltodextrin, 1capsule/day, 60days
干预措施: placebo (Dietary Supplement)
probiotic K56
Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days
干预措施: Lactobacillus paracasei K56 (Dietary Supplement)
结局指标
主要结局
visceral fat area (cm^2)
时间窗: 60days
VFA (cm\^2) will be assessed at baseline and after 60days of intervention
percent body fat (%)
时间窗: 60days
PBF (%) will be assessed at baseline and after 60days of intervention
次要结局
- Body Mass Index BMI(60 days)
- waist circumference (cm)(Baseline, 60 days)
- hip circumference(cm)(60 days)
- waist to hip ratio (WHR)(60 days)
- body weight(60days)
- Serum Lipid Profile(60 days)
- fasting blood glucose(60 days)
- Glycated hemoglobin(60 days)
- Glycosylated albumin(60days)