Impact of Dietary Fibre Consumption on Digestive Comfort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Symptom frequency and intensity scores
研究概览
简要总结
The purpose of this randomised, placebo-controlled, cross-over study is to compare the impact different fibres have on gastrointestinal symptoms when they are consumed individually or as mixtures in healthy adults. The impact of different fibres on the experience of symptoms and stool parameters will be assessed.
详细描述
Global sugar consumption is higher than recommended and there are suggestions that this may be linked to the development of non-communicable diseases including dental caries, and obesity. There are many alternatives to sugars that can be used in foods including certain dietary fibres such as inulin or fructo-oligosaccharides. Most dietary fibres can be fully or partially fermented in the colon by the commensal microbiota, producing beneficial bioactive molecules. However, the rapid production of gas during the fermentation of highly soluble fermentable fibres may cause undesirable symptoms for some people. Dietary exposure to the fibres used in food reformulation, including inulin and soluble corn fibre, is increasing and the impact this may have on gastrointestinal symptoms is unclear. The impact of fibres with different physicochemical characteristics and fermentabilities may differ when consumed in mixtures compared to individually.
The aim of this study is to investigate the impact different fibres have on gastrointestinal symptoms when they are consumed individually or as mixtures and how this relates to the composition of the stool.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported healthy adults (aged 18-65y)
- •Non-smokers
排除标准
- •Individuals with any allergies or conditions affecting bowel health e.g. inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, coeliac disease or diverticular disease
- •Individuals who are pregnant or are trying to get pregnant
- •Individuals with any food allergies
- •Individuals who have taken antibiotics in the past 3 months
- •Individuals who regularly take medication that may modify gastrointestinal function e.g. prokinetic agents (e.g. metoclopramide), antiemetics, constipation treatments (e.g. lactulose, polyethylene glycol)
- •Individuals who consume ≥25g fibre per day
研究组 & 干预措施
Control (Maltodextrin)
Control (Maltodextrin) (0g fibre)
干预措施: Maltodextrin (Dietary Supplement)
Soluble Corn fibre
Soluble corn fibre (SCF) (15g fibre/day)
干预措施: Soluble corn fibre (Dietary Supplement)
Soluble corn fibre and inulin
SCF + In (15g/day fibre)
干预措施: soluble corn fibre and inulin (Dietary Supplement)
Inulin
Inulin (In) (15g fibre/day)
干预措施: Inulin (Dietary Supplement)
结局指标
主要结局
Symptom frequency and intensity scores
时间窗: over 7 days
Symptom frequency and intensity scores for abdominal pain, abdominal bloating and flatulence individually will be reported during each 7-day feeding period. Symptoms will be analysed individually and in combination to create a composite score using a visual analogue scale. This entails making a mark on a horizontal line of 10cm indicating 0 (no symptom) to 10 (worst imaginable symptom). Participants will record the occurrence of each symptom and rate the severity using this scale. The combined score is the sum of each of the symptoms.
次要结局
- Stool frequency(over 7 days)
- Stool form using the Bristol stool chart(Over 7 days)
- Stool water content(Day 1 and day 7)
- Stool acidity(Day 1 and day 7)
- Stool SCFA concentrations(Day 1 and day 7)
研究者
Christine Edwards
Professor
University of Glasgow