Healthy
Conditions
Keywords
gut microbiota, prebiotic intake, Bifidobacterium
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).
Interventions
OTHERInulin
Each intervention provided 10 g/d inulin split into two dosages of 5 g.
Sponsors
University of Reading
Beneo-Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in level of Bifidobacterium spp. | 10 days | Bifidobacterium spp. will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gut bacterial composition | 10 days | Bacterial numbers will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing |
| Stool frequency | 10 days | Numbers of stools will be recorded in daily diary |
| Stool consistency | 10 days | Stool consistency will be recorded in daily diary according to Bristol Stool Form Scale |
| Bloating | 10 days | Bloating will be recorded in daily diary according to a 4-point scale |
| Changes in level of total Bacteria | 10 days | Total bacteria will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) |
| Abdominal pain | 10 days | Abdominal pain will be recorded in daily diary according to a 4-point scale |
| Flatulence | 10 days | Flatulence will be recorded in daily diary according to a 4-point scale |
| Changes in urinary metabolites | 10 days | Urinary metabolites will be analysed by Nuclear magnetic resonance (NMR) |
| Abdominal pressure | 10 days | Abdominal pressure will be recorded in daily diary according to a 4-point scale |
Countries
United Kingdom
Outcome results
None listed