Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Body mass index
研究概览
简要总结
Obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function. Potential mediators of intestinal microbiota are prebiotics, supplements considered safe because they are naturally contained in food and human microbiota. Probiotics are living bacteria which are found in the normal gut microbiota. Synbiotics are combinations of both prebiotics and probiotics. Their use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including severe obesity.
This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of synbiotic supplementation (fructo-oligosaccharide and probiotic - 12 g / day) on body mass index in participants with obesity class III, with follow up of 90 days.
详细描述
Obesity has been discussed as one of the major diseases that require scientific and technological innovations for its control is obesity and studies indicate that microbiota of obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function and the combination of toxins to protein.
Potential mediators of intestinal microbiota are prebiotics, probiotics and synbiotics, supplements considered safe because they are naturally contained in food and human microbiota. Its use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including in severe obesity.
This study aims to analyze the effect of synbiotics supplementation on body mass index in participants diagnosed with morbid obesity. The methodology used is the randomized clinical trial, placebo-controlled with blinding of patients, healthcare staff and outcome assessors, with follow-up of 90 days.
Patients will be randomized into two groups: control group to receive placebo (polydextrose - 12 g / day) and synbiotic group - group supplemented with synbiotic (fructo-oligosaccharide and probiotics - 12 g / day). Probiotics are: Lactobacillus acidophilus; Lactobacillus rhamnosus; Lactobacillus paracasei; Bifïdobacterium lactis.
At the moments proposed in this study, will be conducted assessments of food intake, nutritional status and metabolic / inflammatory parameters (body mass index, high-sensitivity C-reactive protein, albumin, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol, fasting blood glucose, glycated hemoglobin, fasting insulin, weight, height).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity class III (body mass index ≥40kg/m2)
排除标准
- •Current use of prebiotics and probiotics or use in the last three months
- •Intolerance to prebiotics and probiotics
结局指标
主要结局
Body mass index
时间窗: 90 days
次要结局
- Glycated hemoglobin(90 days)
- Adverse events(90 days)
- Total cholesterol(90 days)
- Plasma HDL-cholesterol(90 days)
- Plasma triglycerides(90 days)
- Tumoral Necrose Factor (TNF-α)(90 days)
- Arterial blood pressure(90 days)
- Interleucin I-ß(90 days)
- Plasma C-reactive protein(90 days)
- Plasma LDL-cholesterol(90 days)
- Interleucin 6(90 days)
- Albumin(90 days)
- Blood glucose(90 days)
- Plasma insulin(90 days)
研究者
Marilyn Gonçalves Ferreira Kuntz
Principal Investigator
Hospital Dona Helena