Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans

December 19, 2022 updated by: Beneo-Institute

Randomized Four-arm Trial Investigating the Effects of Different Food Matrices on the Prebiotic Efficacy of Inulin Type Fructans (ITF) From Chicory Root

The aim of the study is to investigate whether the food matrix has an influence on the prebiotic efficacy (bifidobacteria growth) of chicory-derived Orafti® inulin in healthy adult volunteers. The main question it aims to answer is:

Does the food matrix influence the prebiotic effect of chicory-derived inulin in terms of stimulation of bifidobacteria in the gut microbiota Participants will receive one of three food items containing inulin or pure inulin dissolved in water daily for 10 days. The food items or pure inulin powder will deliver 10 g/d inulin split into two dosages of 5 g/d. They will provide stool samples before and at the end of the intake period. They will record any gastrointestinal sensations and bowel habits in a diary. Urinary samples will be collected at baseline and end of intervention for analysis of metabolites with Nuclear Magnetic resonance (NMR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Reading, United Kingdom, RG6 6DZ
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteer is healthy at the time of pre-examination
  • Volunteer is aged ≥ 18 to ≤ 65 years at the time of pre-examination
  • Volunteer's BMI is ≥ 18,5 and ≤ 29,9
  • Volunteer follows an average Western European diet
  • Volunteer has a stool frequency of at least 3 bowel movements per week
  • Volunteer is able and willing to comply with the study instructions
  • Volunteer is suitable for participation in the study according to the investigator/study personnel
  • Written informed consent is given by volunteer

Exclusion Criteria:

  • No command of any local language
  • Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment
  • Food allergies or intolerances
  • Vegetarians, vegans and/or extreme diets including high protein/fibre, ketogenic, intermittent fasting and/or carnivore
  • Using drugs (e.g. antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function (8 weeks before intervention)
  • Use of laxatives and labelled pre- and probiotics in the previous 4 weeks before the beginning of intervention
  • Clinically significant diabetes
  • Volunteers currently involved or will be involved in another clinical or food study
  • History of drug (pharmaceutical or recreational) or alcohol abuse.
  • Has received bowel preparation for investigative procedures in the 4 weeks prior to the study
  • Has undergone surgical resection of any part of the bowel.
  • If participants are pregnant or are lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pure inulin
2 x 5 g/d inulin
Other: Inulin
Each intervention provided 10 g/d inulin split into two dosages of 5 g.
Experimental: Shortbread containing inulin
2 x per day shortbread containing 5 g inulin per serving
Other: Inulin
Each intervention provided 10 g/d inulin split into two dosages of 5 g.
Experimental: Rice drink containing inulin
2 x per day rice drink containing 5 g inulin per serving
Other: Inulin
Each intervention provided 10 g/d inulin split into two dosages of 5 g.
Experimental: Milk chocolate containing inulin
2 x per day milk chocolate containing 5 g inulin per serving
Other: Inulin
Each intervention provided 10 g/d inulin split into two dosages of 5 g.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in level of Bifidobacterium spp.
Time Frame: 10 days
Bifidobacterium spp. will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in level of total Bacteria
Time Frame: 10 days
Total bacteria will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW)
10 days
Changes in gut bacterial composition
Time Frame: 10 days
Bacterial numbers will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing
10 days
Stool frequency
Time Frame: 10 days
Numbers of stools will be recorded in daily diary
10 days
Stool consistency
Time Frame: 10 days
Stool consistency will be recorded in daily diary according to Bristol Stool Form Scale
10 days
Bloating
Time Frame: 10 days
Bloating will be recorded in daily diary according to a 4-point scale
10 days
Abdominal pressure
Time Frame: 10 days
Abdominal pressure will be recorded in daily diary according to a 4-point scale
10 days
Abdominal pain
Time Frame: 10 days
Abdominal pain will be recorded in daily diary according to a 4-point scale
10 days
Flatulence
Time Frame: 10 days
Flatulence will be recorded in daily diary according to a 4-point scale
10 days
Changes in urinary metabolites
Time Frame: 10 days
Urinary metabolites will be analysed by Nuclear magnetic resonance (NMR)
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beneo-Institute

Collaborators

University of Reading

Investigators

  • Principal Investigator: Robert A Rastall, Prof, University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

May 22, 2021

Study Completion (Actual)

October 6, 2021

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY Number - 36/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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