NCT03505177已完成不适用
Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
Nathalie Delzenne2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年4月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Gut microbiota composition
研究概览
简要总结
The aim of this research study is to characterize gut microbiota composition and activity after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a monocentric longitudinal intervention study without control will be performed. Fecal microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured. In addition, during ten hours following the ingestion of a test meal rich in fibers, the kinetic of production of H2, methane and volatile compounds exhaled from breath will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Woman or man, aged of 18 to 40 years
- •Body mass index (BMI) between 18 and 25 kg/m2
- •In good general health as evidenced by medical history and physical examination
- •Non-smoker
- •Caucasian
- •H2 - producer
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Subjects presenting gastro-intestinal disorders such as ulcers, diverticulitis and inflammatory bowel diseases
- •Subject presenting allergy or food intolerance (lactose, gluten,...)
- •Subjects with psychiatric problems and/or using antipsychotics
- •Current or recent (< 4 weeks) intake of antibiotic, probiotic, prebiotic, fiber supplement, and/or any product modulating gut transit
- •Feeding particular diet such as vegetarian diet or hyper protein diet
- •Chronic intake of drug, excepted contraceptive drug
- •Pregnant or lactating woman or woman who did not use highly effective contraception
- •Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day)
- •Subjects having participated to another clinical trial two weeks before the screening test visit
- •Subjects presenting an allergy or intolerance to one component of the product tested
研究组 & 干预措施
Chitin-glucan
Experimental
Supplementation during 3 weeks with 4.5g per day of chitin-glucan fiber
干预措施: Chitin-glucan fiber (Dietary Supplement)
结局指标
主要结局
Gut microbiota composition
时间窗: Difference between day 0 and day 21
Illumina sequencing of 16SrDNA
次要结局
- Fecal short-chain fatty acids(Difference between day 0 and day 21)
- Fecal bile acids(Difference between day 0 and day 21)
- Exhaled acetate(Difference between day 0 and day 21)
- Fecal conjugated-linoleic acids(Difference between day 0 and day 21)
- Exhaled propionate(Difference between day 0 and day 21)
- Exhaled H2S(Difference between day 0 and day 21)
- Exhaled CH4(Difference between day 0 and day 21)
- Exhaled H2(Difference between day 0 and day 21)
- Gastro-intestinal symptom - nausea(Difference between Day 0 and Day 21)
- Exhaled butyrate(Difference between day 0 and day 21)
- Exhaled C2(Difference between day 0 and day 21)
- Exhaled CO2(Difference between day 0 and day 21)
- Exhaled O2(Difference between day 0 and day 21)
- Exhaled CO(Difference between day 0 and day 21)
- Gastro-intestinal symptom - flatulences(Difference between Day 0 and Day 21)
- Gastro-intestinal symptom - gastrointestinal reflux(Difference between Day 0 and Day 21)
- Exhaled N2(Difference between day 0 and day 21)
- Exhaled volatile compounds(Difference between day 0 and day 21)
- Gastro-intestinal symptom - discomfort(Difference between Day 0 and Day 21)
- Gastro-intestinal symptom - cramps(Difference between Day 0 and Day 21)
- Gastro-intestinal symptom - rumbling(Difference between Day 0 and Day 21)
- Gastro-intestinal symptom - burps(Difference between Day 0 and Day 21)
- Gastro-intestinal symptom - bloating(Difference between Day 0 and Day 21)
研究者
Nathalie Delzenne
Professor
Université Catholique de Louvain
研究点 (2)
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