Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPurdue University
About this trial
The main aim of this study is to investigate differences in rate, extent of change and persistence of the gut microbiota in healthy adult volunteers in response to native chicory inulin. Along with investigating the impact of native chicory on bowl habits, mood and appetite. The two main questions this study aims to answer:
* To what extent do differences exist in rate of change over time between individuals in gut microbiota response (Bifidobacterium growth) to native chicory inulin supplementation. * To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation.
The effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation.
Participants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks. Inulin will be delivered at 12 g/day split into 2 x 6g portions. Maltodextrin will be calorie matched at 6 g/day split into 2 x 3g portions. This will then be followed by a 6 week post-supplementation phase. Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest. Participants will also record any changes in gastrointestinal sensation, bowel habits and mood in a diary. Changes in appetite sensation will also measured.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
adults aged 18-45
BMI >18.5 - < 30 kg/m2
Regular bowel movements (> 4 days per week)
Disqualifiers
Self-reported sensitivity to FODMAPs and following a low FODMAP diet ((FODMAPS stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols).
Self-reported food allergies and sensitivities including gluten, dairy, nuts, soya and lactose etc.
Self-reported antibiotic treatment in the past 6 months.
Self-reported history of gastrointestinal disease and/or heart disease, cardiovascular, liver, and respiratory disorders, cancer and/or clinically relevant (pre) diabetes.
Trial design
Design model
Parallel
Treatments tested in this trial
Inulin
Other intervention12 g/day prebiotic supplement taken daily split into 2 dosages of 6 g dissolved in water
Maltodextrin
Other intervention6 g/day maltodextrin taken daily split into 2 dosages of 3 g dissolved in water
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Pure InulinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Bifidobacterium counts in stool samples
Bifidobacterium counts will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing
Time frame
13 weeksSecondary outcomes
1
Total bacteria in stool samples
Total bacteria will be assessed in stool samples by fluorescence in situ hybridisation - flow cytometry.
Time frame
13 weeks2
Changes in gut bacterial composition
Microbiota composition at baseline and throughout the course the 13-week intervention will be assessed by 16S rRNA gene sequencing.
Time frame
13 weeks3
Changes in gut fermentation kinetics
Changes in gut fermentation kinetics (rates of change in bacterial counts) will be conducted using 24 h in vitro fermentations at 10 timepoints throughout the 13 week study duration. Aliquots will be collected at 0, 4, 8, 12 and 24 hours. Changes in kinetics will be assessed using fluorescence in situ hybridisation - flow cytometry.
Time frame
10 days over 13 weeks4
Changes in short-chain fatty acid production
Changes in short-chain fatty acid production will be conducted using 24 h in vitro fermentations at 10 timepoints throughout the 13 week study duration. Aliquots will be collected at 0, 4, 8, 12 and 24 hours during each fermentation and changes in short-chain fatty acid production will be assessed using gas chromatography.
Time frame
10 times over 13 weeksSponsors and contacts
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Source ClinicalTrials.gov