Clinical trial NCT05830032: Impact of Dietary Fibre Consumption on Digestive Comfort
Official title: Impact of Dietary Fibre Consumption on Digestive Comfort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Discomfort
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Mondelēz International, Inc.
First posted: 2023-04-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Healthy adults will be recruited for this single blind randomised controlled cross over study. Participants will be provided with powdered fibres and a non-fibre control (blinded) with detailed instruction on how to dilute these to produce an orange flavoured drinks. They will record any digestive symptoms experienced over four different 7-day intervention arms. The participants will record their bowel habits (stool frequency and form) during these intervention periods and provide stool samples before and after each period from which we will measure pH, water content and short chain fatty acids (SCFA) concentration.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom frequency and intensity scores
timeFrame: over 7 days
Secondary outcomes:
measure: Stool frequency
timeFrame: over 7 days
measure: Stool form using the Bristol stool chart
timeFrame: Over 7 days
measure: Stool water content
timeFrame: Day 1 and day 7
measure: Stool acidity
timeFrame: Day 1 and day 7
measure: Stool SCFA concentrations
timeFrame: Day 1 and day 7
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Human Nutrition New Lister Building
Study officials:
affiliation: University of Glasgow
name: Christine A Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Ada L Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References: