Impact of Dietary Fibre Consumption on Digestive Comfort

NCT ID: NCT05830032

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-25

Brief Summary

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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

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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

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Gastrointestinal Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Soluble Corn fibre

Soluble corn fibre (SCF) (15g fibre/day)

Group Type EXPERIMENTAL

Soluble corn fibre

Intervention Type DIETARY_SUPPLEMENT

As a powdered beverage

Inulin

Inulin (In) (15g fibre/day)

Group Type EXPERIMENTAL

Inulin

Intervention Type DIETARY_SUPPLEMENT

As a powdered beverage

Soluble corn fibre and inulin

SCF + In (15g/day fibre)

Group Type EXPERIMENTAL

soluble corn fibre and inulin

Intervention Type DIETARY_SUPPLEMENT

As a powdered beverage

Control (Maltodextrin)

Control (Maltodextrin) (0g fibre)

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

As a powdered beverage

Interventions

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Soluble corn fibre

As a powdered beverage

Intervention Type DIETARY_SUPPLEMENT

Inulin

As a powdered beverage

Intervention Type DIETARY_SUPPLEMENT

soluble corn fibre and inulin

As a powdered beverage

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

As a powdered beverage

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mondelēz International, Inc.

INDUSTRY

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role lead

Responsible Party

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Christine Edwards

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine A Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Ada L Garcia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Human Nutrition New Lister Building

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Catriona L Thomson, MSc

Role: CONTACT

0141 9560579 ext. 60579

Christine A Edwards, PhD

Role: CONTACT

0141 9560579 ext. 60579

Facility Contacts

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Catriona L Thomson, MSc

Role: primary

Christine A Edwards, PhD

Role: backup

Other Identifiers

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CP/2294514

Identifier Type: -

Identifier Source: org_study_id

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