Study of the Impact of Daily Bread Consumption Enriched With a Fibre Mix on Intestinal Microbiota and Metabolic Profile in Subjects at Metabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bridor
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline Intestinal microbiota composition at eight weeks
研究概览
简要总结
The level of fibre consumption in France is lower than the national and international recommendations (mean 18.8 g/d for men, 16.4 g/d for women (INCA 2007 Study) instead of 30g/d recommended). Fibre have beneficial effects on health and interact with the intestinal microbiota diversity: a diet fortified with different structure fibres increase of 25 % the dysbiotic intestinal microbiota in obese patient (Cotillard et al, Dietary intervention impact on gut microbial gene richness. Nature, August 2013). The study aim is to evaluate the impact of daily consumption of bread (150 g ) enriched with a mixture of fibres of different structure (15g) during two months on the intestinal microbiota composition in metabolic risk subjects (abdominal overweight or obese) and also, to assess the correlation between the microbiota change and their metabolic profile improvement.It is a mono centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index of 25 to 35 kg/m2
- •Waist circumference greater than 80 cm for women and than 96 cm for men
- •Low level of fibre intake (<20 g /d) and low level of fibre nature diversity
- •Daily bread consumption
排除标准
- •Bread products allergy or intolerance
- •Digestive surgery history except appendicectomy
- •Metabolic or gastrointestinal disease history
- •Medication that could interfere with glucose and lipid metabolism or intestinal microbiota (for example, no antibiotics within the 3 months before the study)
- •Smokers (5 cig/d or more)
结局指标
主要结局
Change from Baseline Intestinal microbiota composition at eight weeks
时间窗: baseline and eight weeks
intestinal microbiota composition will be measured by metagenomic analysis before all interventions, and before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)
次要结局
- Change from baseline fasting and post prandial plasma Insulin at eight weeks(baseline and eight weeks)
- Change from baseline MDA (Malon Di Aldehyde) at eight weeks(baseline and eight weeks)
- Change from baseline fasting and post prandial plasma glucose at eight weeks(baseline and eight weeks)
- Change from baseline C-Reactive Protein at eight weeks(baseline and eight weeks)
- Change from baseline Acetylated ghrelin at eight weeks(baseline and eight weeks)
- Change from baseline Satiety evaluation at eight weeks(baseline and eight weeks)
- Change from baseline fasting and post prandial plasma triglycerides at eight weeks(baseline and eight weeks)
- Change from baseline fasting and post prandial plasma non-esterified fatty acids at eight weeks(baseline and eight weeks)
- Change from baseline fibre intake at eight weeks(baseline and eight weeks)
- Change from baseline fasting plasma lipids (cholesterol total, cholesterol HDL and LDL) at eight weeks(baseline and eight weeks)
- Change from baseline Body composition at eight weeks(baseline and eight weeks)
- Change from baseline stool consistency at eight weeks(baseline and eight weeks)
- Change from Baseline Resting Energy Expenditure at eight weeks(baseline and eight weeks)
- Change from Baseline substrate oxydation at eight weeks(baseline and eight weeks)
- Change from baseline Gastrointestinal tolerance symptoms at eight weeks.(baseline and eight weeks)