The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- IL-6 serum will be assessed in participants before and after the intervention.
研究概览
简要总结
In spite of the growing evidence for the beneficial effects of probiotics, their anti-obesity effects are not well examined. No previous studies were conducted in this research area in the UAE. Hence, the aims of this study are to 1) Investigate the link between metabolic derangements associated with obesity and levels of LPS and LBP; 2) Study the relatedness of low grade inflammation with the ME; 3) Investigate the food intake assessment; and 4) Investigate the effectiveness of probiotics supplement on the obesity, ME and inflammation.
This project will have two phases: 1) a cross-sectional, in which 250 adults will be recruited for the collection of anthropometric measures, food intake, and fasting blood samples to measure serum LPS, LBP, Lipid profile, IR, insulin-like growth factor, hs-CRP, IL-6, and glucose. 2) Intervention phase, in which 50 overweight subjects will be randomly assigned to either receive a daily probiotic (25 subjects) or a placebo capsule (25 subjects) during the intervention period.
详细描述
General Objective:
To study the relatedness of obesity, with the associated metabolic endotoxemia and low-grade inflammation, and the effectiveness of probiotics intervention in adults, in UAE.
Specific Aims:
- Investigate the link between metabolic derangements associated with obesity and levels of LPS and LBP among the population in Sharjah, UAE.
- To examine the associated factors of obesity among the same population, including socio-demographic data, anthropometric measures, body composition analysis, and food frequency assessment.
- To investigate the correlation of the inflammatory marker Il-6 and hs-CRP to the levels of endotoxemia in lean, overweight and obese subjects.
- To evaluate the change in endotoxemia, body mass index (BMI) and inflammatory markers, after consumption of probiotics capsules of blended strains of Lactobacillus for 8 consecutive weeks among overweight and obese individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
both drugs pills and placebo pills are provided in identical pharmaceutical shape and packing, and provided by the same manufacturer. Participants is blinded.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accepts healthy volunteers
- •250 male and female
- •age (18 - 55 yrs.)
- •living in Dubai or Sharjah.
排除标准
- •Pregnant breastfeeding or post menopause female
- •individuals with thyroid
- •individuals with liver, kidney or internal organs disorders
- •individuals with signs of hypersensitivity
- •individuals with have known allergy to probiotics, immune-disorder, malignant tumor.
- •individuals with any major surgery during the last 6 months
- •current smokers individuals with, acute illness within 2 weeks before collecting blood samples
结局指标
主要结局
IL-6 serum will be assessed in participants before and after the intervention.
时间窗: 8 weeks
IL-6 serum will be assayed using ELISA
TNF-alpha serum level will be assessed in participants before and after the intervention
时间窗: 8 weeks
TNF-alpha will be assayed using ELISA technique
80 participants characterized with obesity will be assessed for endotoxemia using LAL Chromogenic Endpoint Assay
时间窗: 8 weeks
Estimate the serum levels of LPS (EU/ml) before and after intervention period.
hs-CRP serum level will be assessed in participants before and after the intervention
时间窗: 8 weeke
hs-CRP will be assayed using immunoturbidimetry (ITM)
Lipid profile will be assayed for all participants before and after the intervention
时间窗: 8 weeks
measurement of serum levels of TG, HDL,LDL,
Lipopolysacharide binding protein (LBP) will be assessed in the participants before and after intervention period.
时间窗: 8 weeks
LBP plasma level (ng/ml) will be assayed using ELISA technique
80 participants characterized with obesity will be assessed for body mass index (BMI) before and after the intervention period
时间窗: 8 weeks
BMI ( kg/m2)
次要结局
未报告次要终点
研究者
Sondos Harfil
lecturer
University of Sharjah