Impact of Dietary Fibre Consumption on Digestive Comfort (Fibrecomf)

April 25, 2023 updated by: Christine Edwards, University of Glasgow
The purpose of this randomised, placebo-controlled, cross-over study is to compare the impact different fibres have on gastrointestinal symptoms when they are consumed individually or as mixtures in healthy adults. The impact of different fibres on the experience of symptoms and stool parameters will be assessed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Global sugar consumption is higher than recommended and there are suggestions that this may be linked to the development of non-communicable diseases including dental caries, and obesity. There are many alternatives to sugars that can be used in foods including certain dietary fibres such as inulin or fructo-oligosaccharides. Most dietary fibres can be fully or partially fermented in the colon by the commensal microbiota, producing beneficial bioactive molecules. However, the rapid production of gas during the fermentation of highly soluble fermentable fibres may cause undesirable symptoms for some people. Dietary exposure to the fibres used in food reformulation, including inulin and soluble corn fibre, is increasing and the impact this may have on gastrointestinal symptoms is unclear. The impact of fibres with different physicochemical characteristics and fermentabilities may differ when consumed in mixtures compared to individually.

The aim of this study is to investigate the impact different fibres have on gastrointestinal symptoms when they are consumed individually or as mixtures and how this relates to the composition of the stool.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Self-reported healthy adults (aged 18-65y)
  • Non-smokers

Exclusion criteria:

  • Individuals with any allergies or conditions affecting bowel health e.g. inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, coeliac disease or diverticular disease
  • Individuals who are pregnant or are trying to get pregnant
  • Individuals with any food allergies
  • Individuals who have taken antibiotics in the past 3 months
  • Individuals who regularly take medication that may modify gastrointestinal function e.g. prokinetic agents (e.g. metoclopramide), antiemetics, constipation treatments (e.g. lactulose, polyethylene glycol)
  • Individuals who consume ≥25g fibre per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soluble Corn fibre
Soluble corn fibre (SCF) (15g fibre/day)
Dietary supplement: Soluble corn fibre
As a powdered beverage
Experimental: Inulin
Inulin (In) (15g fibre/day)
Dietary supplement: Inulin
As a powdered beverage
Experimental: Soluble corn fibre and inulin
SCF + In (15g/day fibre)
Dietary supplement: soluble corn fibre and inulin
As a powdered beverage
Placebo Comparator: Control (Maltodextrin)
Control (Maltodextrin) (0g fibre)
Dietary supplement: Maltodextrin
As a powdered beverage
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom frequency and intensity scores
Time Frame: over 7 days
Symptom frequency and intensity scores for abdominal pain, abdominal bloating and flatulence individually will be reported during each 7-day feeding period. Symptoms will be analysed individually and in combination to create a composite score using a visual analogue scale. This entails making a mark on a horizontal line of 10cm indicating 0 (no symptom) to 10 (worst imaginable symptom). Participants will record the occurrence of each symptom and rate the severity using this scale. The combined score is the sum of each of the symptoms.
over 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: over 7 days
Diary
over 7 days
Stool form using the Bristol stool chart
Time Frame: Over 7 days
Diary for each event
Over 7 days
Stool water content
Time Frame: Day 1 and day 7
2 samples each week
Day 1 and day 7
Stool acidity
Time Frame: Day 1 and day 7
2 samples each week
Day 1 and day 7
Stool SCFA concentrations
Time Frame: Day 1 and day 7
2 samples each week
Day 1 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

Mondelēz International, Inc.

Investigators

  • Principal Investigator: Christine A Edwards, PhD, University of Glasgow
  • Principal Investigator: Ada L Garcia, PhD, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

May 20, 2023

Study Completion (Anticipated)

October 25, 2023

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CP/2294514

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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