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临床试验/NCT02505854
NCT02505854已完成不适用

Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Evaluate the effect of probiotic and symbiotic on weight loss of women obese

研究概览

简要总结

The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and symbiotic contribute with weight loss and improvement of metabolic parameters in women with obesity.

详细描述

We will evaluate the effects of probiotic and symbiotic on weigh loss, blood glucose, lipid profile, metabolomic profile, and gut microbiota composition variables in women with obesity.

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
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Obese (BMI between 30 and 39,9 Kg/m²).

排除标准

  • Pregnancy or nursing;
  • Drinkers;
  • Use of drug or phytotherapic;
  • Diagnosis of any cronic disease;
  • Daily consumption of yogurt.

结局指标

主要结局

Evaluate the effect of probiotic and symbiotic on weight loss of women obese

时间窗: Baseline and 60 days and 15 days after the end of the intervention

Determine and evaluate change in body weight and body mass index after intervention.

次要结局

  • Effect of probiotic and symbiotic on blood glucose(Baseline, 60 days and 15 days after the end of the intervention)
  • Effect of probiotic and symbiotic on insulin resistance(Baseline and 60 days)
  • Effect of probiotic and symbiotic on metabolomic profile(Baseline and 60 days)
  • Effect of probiotic and symbiotic on lipid profile(Baseline and 60 days)
  • Effect probiotic and symbiotic on blood pressure(Baseline,60 days and 15 days after intervention conclusion)
  • Effect of probiotic and symbiotic on gut microbiota composition(Baseline, 60 days and 15 days after intervention conclusion)
  • Effect of probiotic and symbiotic on stool consitency by Bristol scale(Baseline,60 days and 15 days after intervention conclusion)
  • Effect of probiotic and symbiotic on gastrointestinal symptons(Baseline,60 days and 15 days after intervention conclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louise Crovesy de Oliveira

Principal investigator

Universidade Federal do Rio de Janeiro

研究点 (2)

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