Gastrointestinal DiscomfortFibrecomfNCT05830032
Impact of Dietary Fibre Consumption on Digestive Comfort
A study testing Soluble corn fibre, Inulin and soluble corn fibre and inulin in people with Gastrointestinal Discomfort, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Discomfort
- What is being tested?
- Soluble corn fibre, Inulin and soluble corn fibre and inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported healthy adults (aged 18-65y)
- Non-smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Nutrition New Lister Building
Glasgow, G2 3ER
Catriona L Thomson, MSc, 9560579, C.Thomson.5@research.gla.ac.uk
Christine A Edwards, PhD, 9560579, Christine.edwards@glasgow.ac.uk
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Discomfort
- Being tested
- Soluble corn fibre, Inulin, soluble corn fibre and inulin, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble corn fibreDietary supplement
As a powdered beverage
InulinDietary supplement
As a powdered beverage
soluble corn fibre and inulinDietary supplement
As a powdered beverage
MaltodextrinDietary supplement
Also called Placebo
As a powdered beverage
| Study group | Role | What they receive |
|---|---|---|
| Soluble Corn fibre | Experimental | Soluble corn fibre (SCF) (15g fibre/day) Receives: Dietary Supplement: Soluble corn fibre |
| Inulin | Experimental | Inulin (In) (15g fibre/day) Receives: Dietary Supplement: Inulin |
| Soluble corn fibre and inulin | Experimental | SCF + In (15g/day fibre) Receives: Dietary Supplement: soluble corn fibre and inulin |
| Control (Maltodextrin) | Placebo comparator | Control (Maltodextrin) (0g fibre) Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 7 days
Secondary outcomes (5)
Stool frequency
Diary
Measured: over 7 days
Stool form using the Bristol stool chart
Diary for each event
Measured: Over 7 days
Stool water content
2 samples each week
Measured: Day 1 and day 7
Stool acidity
2 samples each week
Measured: Day 1 and day 7
Stool SCFA concentrations
2 samples each week
Measured: Day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Oct 2022
- Primary completion20 May 2023 (estimated)
- Study completion25 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Mondelēz International, Inc.
- Responsible party
- Principal investigator, Christine Edwards, University of Glasgow
- Investigators
- Christine A Edwards, PhD, Principal investigator, University of GlasgowAda L Garcia, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830032
- Sponsor's protocol ID
- CP/2294514
- Acronym
- Fibrecomf
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Fibre Consumption on Digestive Comfort
- ClinicalTrials.gov ID
- NCT05830032
- Acronym / sponsor ID
- Fibrecomf / CP/2294514
- Conditions
- Gastrointestinal Discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Mondelēz International, Inc.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 25 Oct 2023 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Soluble Corn fibre | Experimental | Dietary Supplement: Soluble corn fibreSoluble corn fibre (SCF) (15g fibre/day) |
| Inulin | Experimental | Dietary Supplement: InulinInulin (In) (15g fibre/day) |
| Soluble corn fibre and inulin | Experimental | Dietary Supplement: soluble corn fibre and inulinSCF + In (15g/day fibre) |
| Control (Maltodextrin) | Placebo comparator | Dietary Supplement: MaltodextrinControl (Maltodextrin) (0g fibre) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-reported healthy adults (aged 18-65y)
- Non-smokers
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble corn fibreAs a powdered beverage | Dietary supplement | Soluble Corn fibre |
| InulinAs a powdered beverage | Dietary supplement | Inulin |
| soluble corn fibre and inulinAs a powdered beverage | Dietary supplement | Soluble corn fibre and inulin |
| MaltodextrinAlso: PlaceboAs a powdered beverage | Dietary supplement | Control (Maltodextrin) |
Primary outcome
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.
5 secondary outcomes
Stool frequency
Time frame: over 7 days
Stool form using the Bristol stool chart
Time frame: Over 7 days
Stool water content
Time frame: Day 1 and day 7
Stool acidity
Time frame: Day 1 and day 7
Stool SCFA concentrations
Time frame: Day 1 and day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine A Edwards, PhD principal investigator
University of Glasgow
Ada L Garcia, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble corn fibre, Inulin and soluble corn fibre and inulin in people with Gastrointestinal Discomfort, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catriona L Thomson, MSc (0141 9560579 ext. 60579, C.Thomson.5@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom frequency and intensity scores (time frame: over 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.