Effects of Probiotic Treatment on Body Composition and Insulin Resistance in Patients With Obesity Grade II and III and Its Association With Changes in Intestinal Microbiota
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in body mass index in patients with obesity
研究概览
简要总结
This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and treated with probiotics (1 x 1011 CFU) or placebo for 16 weeks and its associations with intestinal microbiota behaviour
详细描述
A randomized placebo-controlled clinical trial will take place in which both arms will be included in an interventional lifestyle changes program at the Clinic for Integral Treatment of patients with Diabetes and Obesity. The study group will be treated with probiotics (1 x 1011 CFU) for 16 weeks and will be compared to a control group who will receive placebo.
Changes in body composition (weight, BMI, fat percentage, fat mass, lean body mass) and insulin resistance indexes (HOMA, insulin sensitivity index and Quicki) will be evaluated in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.
Changes in metabolic profile (glucose tolerance test, glycosylated haemoglobin, lipid profile, leptin and transaminases) in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.
Changes in microRNAs profile (miR-133 and miR-27 in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.
The threshold for basic tastes will be evaluated (salted, bitter, acid, sweet) and will be evaluated in those patients receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to the group receiving only placebo.
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, Care Provider)
盲法说明
Neither the participant nor the Care provider administrating treatment will know the type of treatment.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with grade II y III obesity (IMC > or = 35 Kg/m2), who receive the initial evaluation at the Integral Attention Clinic for Diabetes and Obesity at Hospital General de México
- •Patients who signed informed consent.
排除标准
- •Diabetes mellitus 2
- •Secondary causes of obesity (hypothyroidism, Cushing syndrome).
- •Patients receiving pharmacological treatment that may affect lipid or glucose metabolism.
- •Patients who received broad-spectrum antibiotics during the 4 previous weeks.
- •Ingestion of products that contain probiotics.
- •Relevant changes in diet habits during the 4 previous weeks
- •Intestinal Malabsorption disorders ( inflammatory bowel disease, chronic diarrhea, C. difficile infection).
研究组 & 干预措施
Study group
Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of probiotics for 16 weeks. Probiotics (LACTIPAN®) include 2.5 billion CFU of 6 different strains of live microorganisms, such as Lactobacillus acidophilus (1.0 x 109 CFU), Lactobacillus casei (1.0 x 109 CFU), Lactobacillus rhamnosus (4.4 x 108 CFU), Lactobacillus plantarum (1.76 x 108 CFU), Bifidobacterium infantis (2.76 x 107 CFU), Streptococcus thermophilus (6.66 x 105 CFU) and 50 mg of oligofructose enriched inulin.
干预措施: Probiotics (Dietary Supplement)
Control group
Subjects will be randomly assigned to receive a daily nightly dose (4 capsules) of placebo for 16 weeks. Placebo presentation will have the same aspect as those of the probiotic treatment.
干预措施: Placebo (Other)
结局指标
主要结局
Changes in body mass index in patients with obesity
时间窗: 16 weeks
Evaluate changes in body mass index after probiotics treatment in patients with obesity. Calculated with the weight in kilograms divided by the square of the height in meters
Changes in lean body mass in patients with obesity
时间窗: 16 weeks
Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
Changes in fat percentage in patients with obesity
时间窗: 16 weeks
Evaluate changes in fat percentage after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
Changes in Quicki insulin sensitivity index
时间窗: 16 weeks
Modification in Quicki index after probiotics treatment in patients with obesity
Changes in Insulin resistance indexes
时间窗: 16 weeks
Modification in HOMA index after probiotics treatment in patients with obesity
Changes in fat mass in patients with obesity
时间窗: 16 weeks
Evaluate changes in fat mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis
Changes in weight in patients with obesity
时间窗: 16 weeks
Evaluate changes in weight kilograms after probiotics treatment in patients with obesity
Changes in Insulin sensitivity indexes
时间窗: 16 weeks
Modification in insulin sensitivity index after probiotics treatment in patients with obesity
次要结局
- Changes in glucose tolerance test(16 weeks)
- Changes in uric acid(16 weeks)
- Changes in leptin(16 weeks)
- Changes in glycated haemoglobin(16 weeks)
- Changes in triglycerides(16 weeks)
- Changes in total cholesterol(16 weeks)
- Changes in HDL cholesterol(16 weeks)
- Changes in LDL cholesterol(16 weeks)
- Changes in alanine aminotransferase(16 weeks)
- Changes in aspartate aminotransferase(16 weeks)
研究者
Nayely Garibay Nieto
Head Child and Adolescent Obesity Clinic
Hospital General de México Dr. Eduardo Liceaga