Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin (COCOA3)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Breath hydrogen AUC
研究概览
简要总结
The aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
详细描述
- BACKGROUND AND RATIONALE
The challenge is to understand how various dietary fibres interact to alter colonic fermentation of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) with the aim of reducing gaseous distension of the colon and hence symptoms. Previous studies 1 have shown how psyllium, a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon. The investigation will exploiting a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances 2.
The mode of action of methylcellulose and psyllium on the reduction in gas production from inulin remains unclear. Possible mechanisms include 1) slowing delivery to the colon by their effect in the small bowel, 2) delayed release of inulin from the dietary fibre gel matrix (i.e. a physical effect) in the colon 3) or a direct effect on the colonic bacteria reducing their production of gas (i.e. a microbiological effect).
References
Aim This pilot study will test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
gels given in opaque plastic bag
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
- •Aged between 18 and 65 years old.
- •Able to give informed consent.
- •Scoring ≤5 (i.e., mild, or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool in previous 2 weeks using a modified Gastrointestinal Symptom Rating Scale (5).
- •Agrees to consume the meals provided.
- •Agrees to not smoke during the breath hydrogen sampling period.
排除标准
- •• Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.
- •History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.
- •Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix).
- •Intestinal stoma.
- •Any medical condition making participation potentially compromising participation in the study e.g., diabetes mellitus, respiratory disease limiting ability to use breath hydrogen analyser, known intolerance to one of the test substances.
- •Has a body mass index (BMI) value less than 18.5 or greater than
- •Will not agree to follow dietary and lifestyle restrictions required.
- •Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill will be recorded in the CRF but will not be an exclusion criteria).
- •Participants who are taking antibiotics or probiotics as it might alters gut microbiota.
- •Poor understanding of English language.
- •Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM.
- •Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g., cognitive dysfunction, chaotic lifestyle related to substance abuse.
- •Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
结局指标
主要结局
Breath hydrogen AUC
时间窗: 0-6 hours
Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake.
次要结局
- Breath hydrogen AUC(0-24h)
- Whole gut transit(0-7days)
研究者
Robin Spiller
Professor of Gastroenterology
University of Nottingham