Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Fecal SCFA
研究概览
简要总结
The aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. The first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers
- •Body mass index between 25 and 35 kg/m2
- •Waist circumference < 80cm for women and > 94 cm for men
- •Fiber intake <25g/day
排除标准
- •Medical history of digestive surgery or disease
- •Current or recent (<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
- •Current probiotics, prebiotics, fiber complement, and/or any products modulation gut transit
- •Feeding particular diet such as vegetarian diet or hyperprotein diet
- •Current weight loss diet
- •Pregnant or lactating woman or woman who did not use effective contraception
- •Drinking more than 3 glasses of alcohol per day (>30g/day)
研究组 & 干预措施
Chitin-Glucan supplementation
干预措施: Kiotransine (chitin-glucan from aspergillus niger) (Dietary Supplement)
Placebo supplementation
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Fecal SCFA
时间窗: baseline and three weeks
Change from baseline fecal SCFA at three weeks by Gas chromatography-Flame Ionization Detector
次要结局
- gut microbiota composition(baseline and three weeks)
- fecal biliary acids(baseline and three weeks)
- fecal PolyUnsaturated Fatty Acids (PUFA)(baseline and three weeks)
- fecal albumin(baseline and three weeks)
- fecal zonulin(baseline and three weeks)
- fecal calprotectin(baseline and three weeks)
- TLR-agonist in stool(baseline and three weeks)
- Change from baseline CO2, CH4 and H2 kinetics in exhaled gases(baseline and three weeks)
- resting energy expenditure(baseline and three weeks)
- stool consistency(every week, up to three weeks)
- stool frequency(every week, up to three weeks)
- body composition(baseline and three weeks)
- Change from plasma glucose kinetics(baseline and three weeks)
- Change from plasma insulin kinetics(baseline and three weeks)
- Change from plasma Non-Esterifies Fatty-Acid (NEFA) kinetics(baseline and three weeks)
- plasma TriacylGlycerol (TG) kinetics(baseline and three weeks)
- Cholesterol Total, Cholesterol LDL(baseline and three weeks)
- change from baseline dietary intake of fibre(baseline and three weeks)
- gastro-intestinal symptoms(every week, up to three weeks)
- quality of life during the study(baseline and three weeks)