Fiber Intake & Fecal Bulk Enhanced Response

NCT ID: NCT03313440

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2017-12-01

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. 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.

Conditions

Fecal Bulk; Intestinal Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

High wheat fiber

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Low fiber

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Low fiber

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

J. Rettenmaier & Sohne GmbH & Co. KG

UNKNOWN

Sponsor Role: collaborator

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Diederik Esser

Wageningen University and Research Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole de Wit, Dr

Role: PRINCIPAL_INVESTIGATOR

Stichting Wageningen Research

Locations

Stichting Wageningen Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL62342.081.17

Identifier Type: -

Identifier Source: org_study_id