NCT05830032

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

March 24, 2023

Last Update Submit

April 25, 2023

Conditions

Gastrointestinal Discomfort

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • Stool frequency

    over 7 days

  • Stool form using the Bristol stool chart

    Over 7 days

  • Stool water content

    Day 1 and day 7

  • Stool acidity

    Day 1 and day 7

  • Stool SCFA concentrations

    Day 1 and day 7

Study Arms (4)

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

Soluble corn fibreDIETARY_SUPPLEMENT

As a powdered beverage

Soluble Corn fibre
InulinDIETARY_SUPPLEMENT

As a powdered beverage

Inulin
soluble corn fibre and inulinDIETARY_SUPPLEMENT

As a powdered beverage

Soluble corn fibre and inulin
MaltodextrinDIETARY_SUPPLEMENT

As a powdered beverage

Also known as: Placebo
Control (Maltodextrin)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported healthy adults (aged 18-65y)
  • Non-smokers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition New Lister Building

Glasgow, G2 3ER, United Kingdom

RECRUITING

MeSH Terms

Interventions

Inulinmaltodextrin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Christine A Edwards, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

  • Ada L Garcia, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catriona L Thomson, MSc

CONTACT

0141 9560579C.Thomson.5@research.gla.ac.uk

Christine A Edwards, PhD

CONTACT

0141 9560579Christine.edwards@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 26, 2023

Study Start

October 1, 2022

Primary Completion

May 20, 2023

Study Completion

October 25, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)