Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota
NCT Number: NCT06528041
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Inulin|OTHER: Maltodextrin
Sponsor: Purdue University
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2026-08-30
Locations: Purdue University, West Lafayette, Indiana, 47907, United States

Summary:
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.

Primary Outcome Measures: 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, 13 weeks
Secondary Outcome Measures: Total bacteria in stool samples, Total bacteria will be assessed in stool samples by fluorescence in situ hybridisation - flow cytometry., 13 weeks|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., 13 weeks|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., 10 days over 13 weeks|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., 10 times over 13 weeks|Stool frequency, Stool frequency will be assessed as effective number of bowel movements in a daily diary during baseline and both intervention and post-intervention periods., 13 week|Stool consistency according to Bristol Stool Form Scale, Stool consistency will be assessed in a daily diary during baseline and both intervention and post intervention periods. Changes will be assessed using the Bristol Stool Form Scale which asks volunteers to rate stool consistency from 1 (being like rabbit droppings - very constipated) up to 7 (being like water with no solid pieces)., 13 week|Gastrointestinal sensations (bloating), Gastrointestinal sensations (bloating) will be assessed in a daily diary during baseline and both intervention and post-intervention on a 100 point visual analogue scale (higher scores indicate higher sensation)., 13 week|Gastrointestinal sensations (flatulence), Gastrointestinal sensations (flatulence) will be assessed in a daily diary during baseline and both intervention and post-intervention periods on a 100 point visual analogue scale (higher scores indicate higher sensation)., 13 week|Gastrointestinal sensations (abdominal pain), Gastrointestinal sensations (abdominal pain) will be assessed in a daily diary during baseline and both intervention and post-intervention periods on a 100 point visual analogue scale (higher scores indicate higher sensation)., 13 week|Gastrointestinal sensations (abdominal pressure), Gastrointestinal sensations (abdominal pressure) will be assessed in a daily diary during baseline and both intervention and post-intervention periods on a 100 point visual analogue scale (higher scores indicate higher sensation)., 13 week|Appetite - Feeling of Fullness?, Changes in feeling of fullness will be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - Feeling of hunger?, Changes in feeling of hunger will be assessed in at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - Desire to eat?, Changes in desire to eat will be assessed in at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - How much food could you eat right now?, Changes in how much could you eat right now will be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - How strong is your preoccupations with food?, Changes in how strong is preoccupation with food iswill be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - Feeling of Thirst, Changes in feeling of thirst will be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - Desire to eat something salty, Changes in desire to eat something salty will be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - Desire to eat something fatty, Changes in desire to eat something fatty will be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Appetite - Desire to eat something sweet, Changes in desire to eat something sweet will be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total on a 100 point visual analogue scale., 12 weeks|Transient mood, Changes in transient mood will be assessed using the Positive and Negative Affect Schedule - Short Form Daily questionnaire. The PANAS possesses 20 self-reported measures of positive affect (PA; 10 items) and negative affect (NA; 10 items) that can be used on multiple occasions. Each volunteer will rate the degree to which they were currently experiencing each item on a 5-point Likert scale. Ratings of positive and negative items were summed to give an overall PA and NA score. Scores range from 10 to 50-higher scores indicate higher levels of PA and NA., 13 weeks|Fecal and blood metabolites, Fecal and blood Metabolites (organic compounds) will be assessed at baseline and throughout both the intervention and post-intervention phases at 9 timepoints in total with Nuclear magnetic resonance (NMR). Unsupervised principal component analysis (PCA) and supervised Orthogonal Projections to Latent Structures Discriminant Analysis (OPLS-DA) analysis will be conducted to assess differences between treatments. Correlation coefficients will be generated to show the strength and direction of changes and differences in metabolites between interventions., 12 weeks