Skip to main content
OpenTrials
Completed

NCT Number: NCT03313440

Fiber Intake & Fecal Bulk Enhanced Response

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • 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)

Exclusion criteria

  • 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

Treatment and study plan

High wheat fiber

Other

Daily increased fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention.

Low fiber

Other

Control low fiber intervention. Products are provided in boxes that must be consumed each day during the intervention.

Primary outcomes

  1. Fecal bulk

    Time frame: last 5 days of each intervention period

    Wet and dry weight of stool samples in grams

Secondary outcomes

  1. stool consistency

    Time frame: last 5 days of each intervention period

    by Bristol stool chart (type 1-7)

  2. gut-related complaints

    Time frame: last 5 days of each intervention period

    by questionnaires and Visual Analogue Scale (VAS) scores (on a 90mm horizontal line; from no complains (minimal) to serious complains (maximum)). Higher values represent a worse outcome

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • J. Rettenmaier & Sohne GmbH & Co. KG

Registry information

Acronym: Fiber

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2017
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.