Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- visceral fat area
研究概览
简要总结
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 before-after pilot study, the participants were randomly assigned to 8 groups to compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing different product prototypes , and screen the best probiotic K56 prototype with the effect of fat reduction.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI>=30kg/m2,or percent of body fat(PBF) >=25% for male, >=30 for female.
- •Age: 18 - 60 years old adults
排除标准
- •patients with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome
- •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
- •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
K56 very high dose -E1
Probiotic drink (lactobacillus paracasei K56 10^11CFU) 350ml/d , for 60days
干预措施: probiotic drink with Lactobacillus paracasei K56 (Dietary Supplement)
K56 high dose-E3
Probiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10^10cfu) , for 60days
干预措施: Probiotic powder E3 (Dietary Supplement)
K56 middle dose-E5
Probiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10^9cfu) , for 60days
干预措施: Probiotic powder E5 (Dietary Supplement)
K56 low dose -E7
probiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10^7cfu) , for 60days
干预措施: probiotic capsule E7 (Dietary Supplement)
K56 middle dose-E9
probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^9cfu) ,for 60days
干预措施: probiotic capsule E9 (Dietary Supplement)
K56 high dose-E1K
probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^10cfu), for 60days
干预措施: probiotic capsule E10 (Dietary Supplement)
K56 very high dose-E11
probiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10^11cfu) ,for 60days
干预措施: probiotic capsule E11 (Dietary Supplement)
control -E2
maltodextrin , for 60days
干预措施: maltodextrin (Dietary Supplement)
结局指标
主要结局
visceral fat area
时间窗: 60days
visceral fat area (cm\^2) will be assessed at baseline and after 60days of intervention
percent body fat
时间窗: 60days
percent body fat (%) will be assessed at baseline and after 60days of intervention
次要结局
- Serum Lipid Profile(60 days)
- fasting blood glucose(60 days)
- Glycated hemoglobin(60 days)
- Glycosylated albumin(60 days)
- skeletal muscle mass(60 days)
- waist to hip ratio (WHR)(60 days)
- Body Mass Index BMI(60 days)
- body weight(60 days)