Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Exhaled acetate
研究概览
简要总结
The aim of this research study is to characterize the fermentation of chitin-glucan fiber by assessing the volatile compounds released in the breath. For this purpose, an interventional study with control will be performed. After a single administration of 4.5 g of chitin-glucan fiber, the kinetic of production of exhaled volatile compounds (such as H2, methane, SCFAs,...) will be measured during twelve hours. These results will be compared to the exhaled volatile compounds measured during twelve hours after supplementation with 4.5g of maltodextrin (placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •For women: use of highly effective contraception
- •H2 - producer as evidenced by the screening test (described in latter section)
- •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 antibiotics, probiotics, prebiotics, fiber supplement, and/or any products 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 1 month before the screening test visit
- •Subjects presenting an allergy or intolerance to one component of the product tested
结局指标
主要结局
Exhaled acetate
时间窗: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion
Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled propionate
时间窗: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion
Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
Exhaled butyrate
时间窗: Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion
Gaz chromatography using Flame ionization detector (GC- FID) - Area under the curve (calculated on 12 hours following product ingestion) - Comparison between the test day 0 (ingestion of maltodextrin) and the test day 2 (ingestion of chitin-glucan)
次要结局
- Fecal short-chain fatty acids(Within 4 days before the ingestion of chitin-glucan)
- Fecal bile acids(Within 4 days before the ingestion of chitin-glucan)
- Gastro-intestinal symptom - bloating(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Gut microbiota(within 4 days before the second test day)
- Gastro-intestinal symptom - discomfort(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Exhaled CO(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Gastro-intestinal symptom - gastrointestinal reflux(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Exhaled C2(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Fecal conjugated-linoleic acids(Within 4 days before the ingestion of chitin-glucan)
- Gastro-intestinal symptom - rumbling(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Exhaled H2S(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Exhaled O2(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Exhaled H2(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Exhaled volatils compounds (for other short-chain fatty acids and other volatile organic compounds)(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Gastro-intestinal symptom - nausea(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Gastro-intestinal symptom - flatulences(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Gastro-intestinal symptom - cramps(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Exhaled CH4(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Gastro-intestinal symptom - burps(Before product ingestion (baseline) and 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours and 12 hours after product ingestion)
- Exhaled CO2(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
- Exhaled N2(Before product ingestion (baseline) and 30 minutes, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours and 12 hours after product ingestion)
研究者
Nathalie Delzenne
Professor
Université Catholique de Louvain