Xylo-oligosaccharide (XOS) in Combination With Inulin Modulates Both the Intestinal Environment and Immune Status in Healthy Subjects, While XOS Alone Only Shows Prebiotic Properties
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in the intestinal bifidobacterium at 4 weeks.
研究概览
简要总结
The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.
详细描述
The study followed a randomized, parallel placebo-controlled double-blind design.
A semi-quantitative dietary survey was performed at enrollment in order to assess the usual dietary fiber intake in order to select the target population consuming 13 to 18 g/day. The volunteers were instructed to follow dietary guidelines to maintain their fiber intake during a two-week stabilization phase and then throughout the intervention.
As all volunteers were living on-site and taking all meals at the Institut Polytechnique LaSalle Beauvais cafeteria, the content of each meal could be closely controlled during the week. A 3-day dietary survey was performed at the end of the stabilization period and repeated at the end of the intervention in order to assess the stability of the diet.
The 60 volunteers were randomly assigned to one of three groups and received daily the intervention for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Stable weight (+/- 3 kg) for the last 3 months
- •Body Mass Index (BMI) between 18.5 and 27 kg/m²
- •Consuming between 13 and 18 g of dietary fiber a day
- •Student on campus at the Institut Polytechnique LaSalle Beauvais
- •Informed consent form signed
- •Able to follow the requirement of the study
- •Have a social security
排除标准
- •Has a serious pathology
- •Has a gastrointestinal, vesicular or pancreatic disease
- •Took an antibiotic or a laxative treatment in the last 6 months
- •Surgery of the gastrointestinal tract in the last 12 months
- •Orange juice intolerance
- •Chronic or recurring diarrhea, constipation or abdominal pain
- •Taking drugs known to have an effect on the gastrointestinal, pancreatic and vesicular function
- •Recent gastroenteritis or foodborne illness
- •Consuming regularly of probiotics- or prebiotics-enriched products in the last month
- •Drinking more than 3 glasses of alcohol a day
- •Is deprived of liberty
- •Is under judicial protection
结局指标
主要结局
Change from Baseline in the intestinal bifidobacterium at 4 weeks.
时间窗: 4 weeks
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
次要结局
- Change from Baseline in total microbiota and composition in the feces at 2 weeks.(2 weeks)
- Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks(4 weeks)
- Change from 2 weeks of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks(Between 2 and 4 weeks)
- Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.(4 weeks)
- Change from Baseline in the phenol and p-Cresol in the feces at 2 weeks.(2 weeks)
- Change from Baseline in the faecal pH and dry matter at 2 weeks.(2 weeks)
- Change from Baseline in secretory Immunoglobulin A (IgA) at 4 weeks.(4 weeks)
- Change from Baseline in secretory Immunoglobulin A (IgA) at 2 weeks.(2 weeks)
- Change from Baseline in cytokines at 2 weeks(2 weeks)
- Change from 2 weeks in cytokines at 4 weeks(Between 2 and 4 weeks)
- Change from 2 weeks in dietary intakes at 4 weeks(Between 2 and 4 weeks)
- Change from 2 weeks in the intestinal bifidobacterium at 4 weeks.(Between 2 and 4 weeks)
- Change from Baseline in the intestinal bifidobacterium at 2 weeks.(2 weeks)
- Change from Baseline in total microbiota and composition in the feces at 4 weeks.(4 weeks)
- Change from Baseline in the phenol and p-Cresol in the feces at 4 weeks.(4 weeks)
- Change from 2 weeks in the phenol and p-Cresol in the feces at 4 weeks.(Between 2 and 4 weeks)
- Change from Baseline in cytokines at 4 weeks(4 weeks)
- Change from Baseline in the subjects' tolerance to the test products at 4 weeks.(4 weeks)
- Change from Baseline in the subjects' tolerance to the test products at 2 weeks.(2 weeks)
- Change from 2 weeks in total microbiota and composition in the feces at 4 weeks.(Between 2 and 4 weeks)
- Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 2 weeks(2 weeks)
- Change from 2 weeks in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.(Between 2 and 4 weeks)
- Change from Baseline in dietary intakes at 2 weeks(2 weeks)
- Change from Baseline of circulating lipopolysaccharides (LPS) at 2 weeks.(2 weeks)
- Change from 2 weeks of circulating lipopolysaccharides (LPS) at 4 weeks.(Between 2 and 4 weeks)
- Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 2 weeks.(2 weeks)
- Change from Baseline in the faecal pH and dry matter at 4 weeks.(4 weeks)
- Change from 2 weeks in the faecal pH and dry matter at 4 weeks.(Between 2 and 4 weeks)
- Change from 2 weeks in secretory Immunoglobulin A (IgA) at 4 weeks.(Between 2 and 4 weeks)
- Change from Baseline in dietary intakes at 4 weeks(4 weeks)
- Change from 2 weeks in the subjects' tolerance to the test products at 4 weeks.(Between 2 and 4 weeks)
- Change from Baseline of circulating lipopolysaccharides (LPS) at 4 weeks.(4 weeks)
研究者
Jean-Michel Lecerf
MD, Nutritionist
Institut Pasteur de Lille