Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans

Study Overview
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Brief Summary
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Inulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, prebiotic intake, Bifidobacterium