Effect of Prebiotic and Synbiotic Supplementation on Inflammatory Markers, Metabolic Parameters and Nutritional Status After Roux-en-y Gastric Bypass.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in IL-1 beta concentrations
研究概览
简要总结
The study will recruit patients submitted to bariatric surgery. Individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. Immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass Roux-Y.
详细描述
The study will recruit patients submitted to roux-en-y gastric bypass. Individuals that meet the inclusion criteria will be randomized by means of a computer program on three study groups: 1) Prebiotic group: Oral supplementation with 6g/day of prebiotic for 15 days. 2) Synbiotic group: Oral supplementation with 6g/day of synbiotic for 15 days. 3) Placebo group (control): Oral supplementation with 6g/day of placebo (maltodextrin) for 15 days. Will be assessed the effects of supplementation on the plasma cytokines, plasma lipopolysaccharide (bacterial endotoxin), plasma cellular fatty acid profile, metabolic parameters (lipid profile, glycemic status and insulin resistance) and nutritional status. Blood samples will be collected before the surgery and the supplementation will begin 30 days after surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years and less than 65 years
- •Body mass index (BMI)> 40kg/m2 or> 35kg/m2 with at least one comorbidity
- •Failure in the non-pharmacological and pharmacological treatment.
排除标准
- •Significant intellectual limitations without adequate family support.
- •Uncontrolled psychiatric disorder.
- •Alcohol dependence and / or illicit drugs dependence.
- •Current use of anti-inflammatory drugs and / or antibiotics and / or immunosuppressants
- •Display intolerance prebiotics and / or probiotics and / or symbiotic
- •Having made use of prebiotic and / or probiotic and / or symbiotic prior to the study period.
结局指标
主要结局
Change in IL-1 beta concentrations
时间窗: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated IL-1 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Change in IL-6 concentrations
时间窗: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated IL-6 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
Change in TNF-alpha concentrations
时间窗: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Will be evaluated TNF-alpha plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).
次要结局
- Change in nutritional status(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in risk of inflammatory and nutritional complications(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation))
- Change in fasting glucose concentrations(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in fasting insulin concentrations(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in HOMA-IR index(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in glycated hemoglobin(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in lipid profile(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in plasma monounsaturated fatty acids(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in plasma polyunsaturated fatty acids(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
- Change in plasma saturated fatty acids(Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).)
研究者
Erasmo Benicio Santos de Moraes Trindade
Doctor in Tropical Diseases
Universidade Federal de Santa Catarina