Impact of Dietary Fibre Consumption on Digestive Comfort

Not Applicable

Recruiting

• Conditions: Gastrointestinal Discomfort
• Interventions: Dietary Supplement: Inulin; Dietary Supplement: soluble corn fibre and inulin; Dietary Supplement: Soluble corn fibre; Dietary Supplement: Maltodextrin

• Registration Number: NCT05830032
• Lead Sponsor: University of Glasgow

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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-03-24
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-05-20
• Study Completion: 2023-10-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inulin	Inulin	Inulin (In) (15g fibre/day)
Soluble corn fibre and inulin	soluble corn fibre and inulin	SCF + In (15g/day fibre)
Soluble Corn fibre	Soluble corn fibre	Soluble corn fibre (SCF) (15g fibre/day)
Control (Maltodextrin)	Maltodextrin	Control (Maltodextrin) (0g fibre)

Primary Outcome Measures

Name	Time	Method
Symptom frequency and intensity scores	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 Outcome Measures

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

Trial Locations

Locations (1)

Human Nutrition New Lister Building; 🇬🇧 Glasgow, United Kingdom