Fiber Intake & Fecal Bulk Enhanced Response (Fiber)

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Health; Fecal Bulk
• Intervention / Treatment: Other: High wheat fiber; Other: Low fiber

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high fibre; 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.	Other: High wheat fiber; Daily increased fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention.
Experimental: low fibre; A 10 day control intervention with no additional wheat fibre. Products are provided in boxes that must be consumed each day during the intervention.	Other: Low fiber; Control low fiber intervention. Products are provided in boxes that must be consumed each day during the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal bulk	Wet and dry weight of stool samples in grams	last 5 days of each intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stool consistency	by Bristol stool chart (type 1-7)	last 5 days of each intervention period
gut-related complaints	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	last 5 days of each intervention period

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: J. Rettenmaier & Sohne GmbH & Co. KG
• Investigators: Principal Investigator: Nicole de Wit, Dr, Stichting Wageningen Research

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: diet; Fibre; fecal bulk
• Other Study ID Numbers: NL62342.081.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No