Fiber Intake & Fecal Bulk Enhanced Response

Intestinal Health Clinical Trial

— Fiber  

Official title:

Fiber Intake & Fecal Bulk Enhanced Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313440
• Other study ID #: NL62342.081.17
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: July 2018
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Bulk
• Intestinal Health

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

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University and Research	J. Rettenmaier & Sohne GmbH & Co. KG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal bulk	Wet and dry weight of stool samples in grams	last 5 days of each intervention period
Secondary	stool consistency	by Bristol stool chart (type 1-7)	last 5 days of each intervention period
Secondary	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