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临床试验/NCT03313440
NCT03313440已完成不适用

Fiber Intake & Fecal Bulk Enhanced Response

Wageningen University and Research2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年10月23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
22
试验地点
2
主要终点
Fecal bulk

研究概览

简要总结

Some dietary fibres, including wheat fibres, have shown to increase fecal bulk and improve stool. In previous studies, this effect on fecal bulk was especially studied for intact wheat fibers. Moreover, in most studies, the wheat fiber was offered daily as a single dose in cereals. In this study, we investigate whether an increased intake of extracted wheat fiber, implemented at several time points in a normal daily dietary pattern, can also increase fecal bulk and improve stool frequency and consistency. Here we want to demonstrate that an increase in VITACEL Wheat Fiber intake will enhance fecal bulk, both wet and dry weight and that the enhanced wheat fiber intake will also increase stool frequency and consistency. The study is a double-blind crossover design in which the intervention is based on products enriched by VITACEL Wheat Fiber and control products. Both the control and fiber-enriched intervention will last for 10 days with a wash-out period of at least 4 days. The study will be conducted with 25 healthy male human volunteers in the age between 18-70 years old.Persons will be assigned to the intervention groups. In one of the intervention periods participants receive 'control boxes' with products low in wheat fiber and in the other period they will receive boxes with products enriched with VITACEL Wheat Fiber. During an intervention period of 10 days participants will receive 10 boxes, one for each day. In the last 5 days of the intervention + 1 additional day after the intervention (so in total 6 days), participants will collect their fecal samples to analyse fecal bulk. Daily also a diary has to be kept and questionnaires have to be completed to check compliance to the intervention and assess stool consistency, gut-related complaints.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Apparently healthy (no gastrointestinal complaints, no food allergies and no medication that can influence the outcome of this study
  • Age range between 18-70 years old
  • BMI between 20 and 30 kg/m2
  • Average fiber intake of <23grams per day
  • Living in the surrounding area of Wageningen (radius ~20 km)

排除标准

  • Any digestive tract disorder that is expected to interfere with this study (e.g. (partial) gastric resection, (hemi)colectomy, Crohn's disease, ulcerative colitis, irritable bowel disease, Coeliac disease)
  • Known food allergy (e.g. lactose, gluten, nuts, egg, etc)
  • Vegetarians
  • Use of pro- or prebiotics
  • Use of medication that can interfere with study outcomes (including laxatives, diuretics, antidepressants, codeine or antibiotics)
  • Alcohol intake ≥ 40g/day (≥ 3 glasses of beer/wine per day)
  • Drug abuse
  • Current smokers
  • Participation in other clinical trials in the past month

研究组 & 干预措施

high fibre

Experimental

A 10 day increase in daily wheat fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention.

干预措施: High wheat fiber (Other)

low fibre

Experimental

A 10 day control intervention with no additional wheat fibre. Products are provided in boxes that must be consumed each day during the intervention.

干预措施: Low fiber (Other)

结局指标

主要结局

Fecal bulk

时间窗: last 5 days of each intervention period

Wet and dry weight of stool samples in grams

次要结局

  • stool consistency(last 5 days of each intervention period)
  • gut-related complaints(last 5 days of each intervention period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diederik Esser

Wageningen University and Research Centre

Wageningen University and Research

研究点 (2)

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