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临床试验/NCT03263065
NCT03263065已完成不适用

A Pilot Participant-blind Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging

University of Nottingham2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年4月18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
入组人数
12
试验地点
2
主要终点
Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon

研究概览

简要总结

This study will compare 3 food products (bran, psyllium and nopal) on intestinal water content measured via MRI.

详细描述

BACKGROUND AND RATIONALE

The role of dietary fibre in human health is a topic of both debate and research. Interpreting evidence is complicated by changes in the definition of fibre. In the UK the Scientific Advisory Committee for Nutrition has recently proposed a definition of "all carbohydrates that are neither digested nor absorbed in the small intestine and have a degree of polymerisation of three or more monomeric units, plus lignin". They have also called for further research into the physiological effects of fibre of the gastrointestinal (GI) tract.

The Nottingham GI MRI group has been at the forefront of elucidating the effects of poorly digested carbohydrates on gastrointestinal physiology. The investigators have published techniques to measure free water in the small bowel and assessment of the physical form of chyme in the colon using MR relaxometry. This includes the demonstration that fructose ingestion on its own leads to increased free water in the small bowel compared to co-ingestion with glucose.

Bran is often confused with dietary fibre. Although it contains fibre, the term actually refers to the outer husk of seeds and grains. It has been shown to accelerate oro-caecal transit (OCT) with scintigraphy. Bran can also be shown to increase small bowel water content, possibly by mechanical stimulation, one of the most powerful stimuli for small intestinal secretion, which may be a mechanism to prevent blockage. In the past bran's high fibre content led to the hypothesis that its effect derived from holding water in the lumen but a comparison study of 17 different fibres found an inverse relationship between their water-holding properties and effect on faecal weight, with bran holding the least water but inducing the largest weight changes. Rather, weight change appeared to relate to the amount of undigested fibre present in the faeces and the associated changes in bacterial numbers, which account for most of dry stool weight.

In contrast, psyllium husk contains a fibre that binds water effectively. On this basis it has been used as a laxative for thousands of years. In fact, there is little evidence that psyllium accelerates whole gut transit time as might be expected of a laxative. Work within the investigating group has shown that psyllium increases water in both the small bowel and the faeces, leading to softer, looser 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 (Outcomes Assessor)

盲法说明

Data analysis will be blinded

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 or older
  • Able to give informed consent

排除标准

  • Pregnancy declared by candidate
  • History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
  • A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire
  • 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 lie in the scanner, known allergy to one of the food products
  • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
  • Will not agree to dietary restrictions required in 24 hours before each MRI study day
  • 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 and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
  • Inability to lie flat or exceed scanner limits of weight <120kg
  • 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
  • Participation in any medical trials for the past 3 months
  • 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

研究组 & 干预措施

Nopal added to test meal

Experimental

test meal including nopal powder

干预措施: Nopal (Dietary Supplement)

Bran added to test meal

Experimental

test meal including bran powder

干预措施: Bran (Dietary Supplement)

Psyllium added to test meal

Experimental

test meal including psyllium powder

干预措施: Psyllium (Dietary Supplement)

结局指标

主要结局

Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon

时间窗: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion

measured by MRI

次要结局

  • Change from the baseline in colonic volume in mL(baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion)
  • Change from the baseline in small bowel water content (mL)(baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion)
  • Change from the baseline of breath hydrogen and methane (ppm)(baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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