NCT05581615

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

October 12, 2022

Last Update Submit

December 19, 2022

Conditions

Healthy

Keywords

gut microbiota, prebiotic intake, Bifidobacterium

Outcome Measures

Primary Outcomes (1)

  • Changes in level of Bifidobacterium spp.

    Bifidobacterium spp. will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing

    10 days

Secondary Outcomes (9)

  • Changes in level of total Bacteria

    10 days

  • Changes in gut bacterial composition

    10 days

  • Stool frequency

    10 days

  • Stool consistency

    10 days

  • Bloating

    10 days

  • +4 more secondary outcomes

Study Arms (4)

Pure inulin

ACTIVE COMPARATOR

2 x 5 g/d inulin

Other: Inulin

Shortbread containing inulin

EXPERIMENTAL

2 x per day shortbread containing 5 g inulin per serving

Other: Inulin

Rice drink containing inulin

EXPERIMENTAL

2 x per day rice drink containing 5 g inulin per serving

Other: Inulin

Milk chocolate containing inulin

EXPERIMENTAL

2 x per day milk chocolate containing 5 g inulin per serving

Other: Inulin

Interventions

InulinOTHER

Each intervention provided 10 g/d inulin split into two dosages of 5 g.

Milk chocolate containing inulinPure inulinRice drink containing inulinShortbread containing inulin

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, RG6 6DZ, United Kingdom

Location

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Robert A Rastall, Prof

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 14, 2022

Study Start

November 20, 2020

Primary Completion

May 22, 2021

Study Completion

October 6, 2021

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)