Status:

COMPLETED

Fiber Intake & Fecal Bulk Enhanced Response

Lead Sponsor:

Wageningen University and Research

Collaborating Sponsors:

J. Rettenmaier & Sohne GmbH & Co. KG

Conditions:

Fecal Bulk

Intestinal Health

Eligibility:

MALE

18-70 years

Phase:

NA

Brief Summary

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. Moreove...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 23 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2017

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT03313440

Start Date

October 23 2017

End Date

December 1 2017

Last Update

July 6 2018

Active Locations (1)

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Stichting Wageningen Research

Wageningen, Gelderland, Netherlands, 6708 WG