NCT01176942已完成不适用
Probiotics and Endotoxemia in Humans
Danisco1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention
研究概览
简要总结
The purpose of this study is to determine whether probiotic treatment of overweight volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.
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
- 是
入选标准
- •Body mass index ≥ 27 kg/m2; above 18 years of age
- •Used to eat high fat diet (more than 40% of total energy intake)
排除标准
- •Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia
- •Severe illnesses
- •Artificial heart valve
- •Immunosuppression
- •Regular consumption of probiotics
- •History of bariatric surgery
- •Consumption or wish to consume Orlistat
- •Participation in other research
- •Pregnancy or wishing/trying to get pregnant
- •Inability to follow protocol.
结局指标
主要结局
Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention
时间窗: 12 weeks
Quantitative, kinetic assay for the detection of gram negative bacterial endotoxin (lipopolysaccharide) is used to test whether the probiotic intervention can reduce plasma endotoxin levels (IU/ml) compared to the baseline.
次要结局
- Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention(12 weeks)
- Volunteer weight before and after the 12 week intervention.(12 weeks)
- Volunteer waist perimeter before and after the 12 week intervention(12 weeks)
- Serum inflammatory markers of volunteers before and after the 12 week intervention.(12 weeks)
- Blood lipids in the volunteers before and after the 12 week intervention.(12 weeks)
- Brachial blood pressure of the volunteers before and after the 12 week intervention.(12 weeks)
- Intestinal microbiota composition measured from stool samples before and after the 12 week intervention.(12 weeks)
- Gut function questionaire as a measure of tolerability(Symptoms during last 6 days)
研究者
研究点 (1)
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