Impact of Dietary Fibre Consumption on Digestive Comfort | NCT05830032

Studies
Impact of Dietary Fibre Consumption on Digestive Comfort

NCT05830032

Sponsor

University of Glasgow

Status

Unknown status

Last Update Posted

Apr 26, 2023Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Gastrointestinal Discomfort

Interventions

Soluble corn fibre
Inulin
soluble corn fibre and inulin
Maltodextrin

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

May 20, 2023Estimated

Completion Date

Oct 25, 2023Estimated

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Apr 25, 2023

First Posted Date

Apr 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

Apr 26, 2023Actual

Name	Class
Mondelēz International, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Soluble Corn fibre	Experimental	Soluble corn fibre (SCF) (15g fibre/day)	Dietary Supplement: Soluble corn fibre
Inulin	Experimental	Inulin (In) (15g fibre/day)	Dietary Supplement: Inulin
Soluble corn fibre and inulin	Experimental	SCF + In (15g/day fibre)	Dietary Supplement: soluble corn fibre and inulin
Control (Maltodextrin)	Placebo Comparator	Control (Maltodextrin) (0g fibre)	Dietary Supplement: Maltodextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soluble corn fibre	Dietary Supplement	As a powdered beverage	Soluble Corn fibre

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	over 7 days

Secondary Outcomes

Measure	Description	Time Frame
Stool frequency	Diary	over 7 days
Stool form using the Bristol stool chart	Diary for each event	Over 7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Catriona L Thomson, MSc	Contact	0141 9560579	60579	C.Thomson.5@research.gla.ac.uk
Christine A Edwards, PhD	Contact	0141 9560579	60579	Christine.edwards@glasgow.ac.uk

Overall Officials

Name	Affiliation	Role
Christine A Edwards, PhD	University of Glasgow	Principal Investigator
Ada L Garcia, PhD	University of Glasgow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Human Nutrition New Lister Building	Recruiting	Glasgow		G2 3ER	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007444	Inulin
C008315	maltodextrin

Ancestor Terms

ID	Term
D013213	Starch
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911

Browse Leaves

Not provided

Browse Branches

Not provided

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.