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Clinical Trials/NCT05830032
NCT05830032
Recruiting
Not Applicable

Impact of Dietary Fibre Consumption on Digestive Comfort

University of Glasgow1 site in 1 country12 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Discomfort
Sponsor
University of Glasgow
Enrollment
12
Locations
1
Primary Endpoint
Symptom frequency and intensity scores
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
October 25, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christine Edwards

Professor

University of Glasgow

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Stool frequency(over 7 days)
  • Stool form using the Bristol stool chart(Over 7 days)
  • Stool water content(Day 1 and day 7)
  • Stool acidity(Day 1 and day 7)
  • Stool SCFA concentrations(Day 1 and day 7)

Study Sites (1)

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