Impact of Dietary Fibre Consumption on Digestive Comfort

Gastrointestinal Discomfort Clinical Trial

— Fibrecomf  

Official title:

Impact of Dietary Fibre Consumption on Digestive Comfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830032
• Other study ID #: CP/2294514
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 25, 2023

Study information

• Verified date: April 2023
• Source: University of Glasgow
• Contact: Catriona L Thomson, MSc
• Phone: 0141 9560579
• Email: C.Thomson.5[@]research.gla.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 25, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Discomfort

Intervention

Dietary Supplement:
• Soluble corn fibre
As a powdered beverage
• Inulin
As a powdered beverage
• soluble corn fibre and inulin
As a powdered beverage
• Maltodextrin
As a powdered beverage

Locations

Country	Name	City	State
United Kingdom	Human Nutrition New Lister Building	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	Mondelez International, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom frequency and intensity scores	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	Stool frequency	Diary	over 7 days
Secondary	Stool form using the Bristol stool chart	Diary for each event	Over 7 days
Secondary	Stool water content	2 samples each week	Day 1 and day 7
Secondary	Stool acidity	2 samples each week	Day 1 and day 7
Secondary	Stool SCFA concentrations	2 samples each week	Day 1 and day 7