HealthyNCT05581615
Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans
A study testing Inulin in people with Healthy, run by Beneo-Institute at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2020to 6 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Healthy
- Being tested
- Inulin
- Keywords
- gut microbiota, prebiotic intake, Bifidobacterium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinOther
Each intervention provided 10 g/d inulin split into two dosages of 5 g.
| Study group | Role | What they receive |
|---|---|---|
| Pure inulin | Active comparator | 2 x 5 g/d inulin Receives: Other: Inulin |
| Shortbread containing inulin | Experimental | 2 x per day shortbread containing 5 g inulin per serving Receives: Other: Inulin |
| Rice drink containing inulin | Experimental | 2 x per day rice drink containing 5 g inulin per serving Receives: Other: Inulin |
| Milk chocolate containing inulin | Experimental | 2 x per day milk chocolate containing 5 g inulin per serving Receives: Other: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (9)
Changes in level of total Bacteria
Total bacteria will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW)
Measured: 10 days
Changes in gut bacterial composition
Bacterial numbers will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing
Measured: 10 days
Stool frequency
Numbers of stools will be recorded in daily diary
Measured: 10 days
Stool consistency
Stool consistency will be recorded in daily diary according to Bristol Stool Form Scale
Measured: 10 days
Bloating
Bloating will be recorded in daily diary according to a 4-point scale
Measured: 10 days
Abdominal pressure
Abdominal pressure will be recorded in daily diary according to a 4-point scale
Measured: 10 days
Abdominal pain
Abdominal pain will be recorded in daily diary according to a 4-point scale
Measured: 10 days
Flatulence
Flatulence will be recorded in daily diary according to a 4-point scale
Measured: 10 days
Changes in urinary metabolites
Urinary metabolites will be analysed by Nuclear magnetic resonance (NMR)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start20 Nov 2020
- Primary completion22 May 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Responsible party
- Sponsor
- Investigators
- Robert A Rastall, Prof, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581615
- Sponsor's protocol ID
- STUDY Number - 36/2020
- Status last verified
- Dec 2022
- First submitted
- 12 Oct 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Four-arm Trial Investigating the Effects of Different Food Matrices on the Prebiotic Efficacy of Inulin Type Fructans (ITF) From Chicory Root
- ClinicalTrials.gov ID
- NCT05581615
- Acronym / sponsor ID
- STUDY Number - 36/2020
- Conditions
- Healthy
- Keywords
- gut microbiota, prebiotic intake, Bifidobacterium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pure inulin | Active comparator | Other: Inulin2 x 5 g/d inulin |
| Shortbread containing inulin | Experimental | Other: Inulin2 x per day shortbread containing 5 g inulin per serving |
| Rice drink containing inulin | Experimental | Other: Inulin2 x per day rice drink containing 5 g inulin per serving |
| Milk chocolate containing inulin | Experimental | Other: Inulin2 x per day milk chocolate containing 5 g inulin per serving |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InulinEach intervention provided 10 g/d inulin split into two dosages of 5 g. | Other | Milk chocolate containing inulin, Pure inulin, Rice drink containing inulin, Shortbread containing inulin |
Primary outcome
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
9 secondary outcomes
Changes in level of total Bacteria
Time frame: 10 days
Changes in gut bacterial composition
Time frame: 10 days
Stool frequency
Time frame: 10 days
Stool consistency
Time frame: 10 days
Bloating
Time frame: 10 days
Abdominal pressure
Time frame: 10 days
Abdominal pain
Time frame: 10 days
Flatulence
Time frame: 10 days
Changes in urinary metabolites
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Rastall, Prof principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin in people with Healthy, run by Beneo-Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in level of Bifidobacterium spp. (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.