HealthyINFLUXNCT06528041
Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota
A study testing Inulin and Maltodextrin in people with Healthy, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inulin and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults aged 18-45
- BMI >18.5 - < 30 kg/m2
- Regular bowel movements (> 4 days per week)
Who cannot join
- 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.
- Self-reported to having undergone major surgery of the gastrointestinal tract, with the exception of cholecystectomy and appendectomy.
- Self-reported smoking and/or self-reported drug or alcohol abuse.
Show all 9Show fewer
- Self-reported history of psychiatric and/or mood disorders including eating disorders.
- Self-reported to be following a restrictive diet (i.e. ketogenic, intermittent fasting).
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Purdue University
West Lafayette, Indiana, 47907
Stephen Lindemann, PhD, 765-494-9207, lindems@purdue.edu
Peter Jackson, PhD, 765-509-9789, ppjackso@purdue.edu
About this study
Official title: Effect of Native Chicory Inulin Supplementation on Rates of Microbial Change Between Individuals
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.
Read more
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.
Read the detailed description
The term prebiotic was established in 1995 and has since undergone several updates in definition. As of 2017, the International Scientific Association for Probiotics and Prebiotics (ISAPP) defines prebiotics as a substrates that is selectivity utilised by the host microorganism conferring a health benefit. Of all prebiotics the most highly researched prebiotics are inulin and fructo-oligosaccharides that belong to a group of non-digestible carbohydrates referred to as inulin-type fructans. The main concept behind prebiotics is to stimulate selective changes in microbiota - namely Bifidobacterium in regards to inulin-type fructans. The ability for inulin-type fructans to stimulate changes in bifidobacteria has been demonstrated across across a wide array of studies. Yet, while in vivo studies suggest that inulin-type fructans exert a bifidogenic effect, substantial differences in changes in bifidobacteria responses are often documented between individuals. More specifically, evidence is lacking regarding differences in the rate, extent of change and persistence of the gut microbiota upon the commencement and seizing of inulin supplementation. While, increasing pre-clinical data suggests that a wide variety of bacteria found within the gut can utilise inulin-type fructans in addition to just Bifidobacterium. The aims of this research study are to explore effects that supplementation with 12 g/day inulin-type fructans has on frequent changes in gut microbiota load, composition, gastrointestinal sensation (flatulence, intestinal bloating, abdominal pain and abdominal pressure), bowel habits (stool frequency and stool consistency) and mood with maltodextrin employed as a placebo ((control) 6 g/day). This study will also examine differences in appetite sensation and blood metabolites. The study will consist of 3 phases - a one-week run-in phase; a 6-week supplementation phase and a 6-week post-supplementation phase.
- Conditions
- Healthy
- Being tested
- Inulin, Maltodextrin
- Keywords
- Gut microbiota, inulin, prebiotics, Bifidobacterium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinOther
12 g/day prebiotic supplement taken daily split into 2 dosages of 6 g dissolved in water
MaltodextrinOther
6 g/day maltodextrin taken daily split into 2 dosages of 3 g dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| Pure Inulin | Experimental | 12 g/day prebiotic supplement Receives: Other: Inulin |
| Placebo | Placebo comparator | 6 g/day maltodextrin Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 13 weeks
Secondary outcomes (21)
Total bacteria in stool samples
Total bacteria will be assessed in stool samples by fluorescence in situ hybridisation - flow cytometry.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Aug 2024
- Primary completion28 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
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
- Model description
- 13 week, 2 arm parallel, double blind, randomised, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen R Lindemann, PhD, Purdue University
- Investigators
- Stephen Lindemann, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528041
- Sponsor's protocol ID
- IRB-2024-154
- Acronym
- INFLUX
- Status last verified
- Dec 2025
- First submitted
- 25 Jul 2024
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Native Chicory Inulin Supplementation on Rates of Microbial Change Between Individuals
- ClinicalTrials.gov ID
- NCT06528041
- Acronym / sponsor ID
- INFLUX / IRB-2024-154
- Conditions
- Healthy
- Keywords
- Gut microbiota, inulin, prebiotics, Bifidobacterium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 30 Jul 2024 (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 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.
Detailed description
The term prebiotic was established in 1995 and has since undergone several updates in definition. As of 2017, the International Scientific Association for Probiotics and Prebiotics (ISAPP) defines prebiotics as a substrates that is selectivity utilised by the host microorganism conferring a health benefit. Of all prebiotics the most highly researched prebiotics are inulin and fructo-oligosaccharides that belong to a group of non-digestible carbohydrates referred to as inulin-type fructans. The main concept behind prebiotics is to stimulate selective changes in microbiota - namely Bifidobacterium in regards to inulin-type fructans. The ability for inulin-type fructans to stimulate changes in bifidobacteria has been demonstrated across across a wide array of studies. Yet, while in vivo studies suggest that inulin-type fructans exert a bifidogenic effect, substantial differences in changes in bifidobacteria responses are often documented between individuals. More specifically, evidence is lacking regarding differences in the rate, extent of change and persistence of the gut microbiota upon the commencement and seizing of inulin supplementation. While, increasing pre-clinical data suggests that a wide variety of bacteria found within the gut can utilise inulin-type fructans in addition to just Bifidobacterium. The aims of this research study are to explore effects that supplementation with 12 g/day inulin-type fructans has on frequent changes in gut microbiota load, composition, gastrointestinal sensation (flatulence, intestinal bloating, abdominal pain and abdominal pressure), bowel habits (stool frequency and stool consistency) and mood with maltodextrin employed as a placebo ((control) 6 g/day). This study will also examine differences in appetite sensation and blood metabolites. The study will consist of 3 phases - a one-week run-in phase; a 6-week supplementation phase and a 6-week post-supplementation phase.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 13 week, 2 arm parallel, double blind, randomised, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pure Inulin | Experimental | Other: Inulin12 g/day prebiotic supplement |
| Placebo | Placebo comparator | Other: Maltodextrin6 g/day maltodextrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults aged 18-45
- BMI >18.5 - < 30 kg/m2
- Regular bowel movements (> 4 days per week)
Key exclusion criteria (9 listed)
- 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.
- Self-reported to having undergone major surgery of the gastrointestinal tract, with the exception of cholecystectomy and appendectomy.
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 |
|---|---|---|
| Inulin12 g/day prebiotic supplement taken daily split into 2 dosages of 6 g dissolved in water | Other | Pure Inulin |
| Maltodextrin6 g/day maltodextrin taken daily split into 2 dosages of 3 g dissolved in water | Other | Placebo |
Primary outcome
Changes in Bifidobacterium counts in stool samples
Time frame: 13 weeks
Bifidobacterium counts will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing
21 secondary outcomes
Total bacteria in stool samples
Time frame: 13 weeks
Changes in gut bacterial composition
Time frame: 13 weeks
Changes in gut fermentation kinetics
Time frame: 10 days over 13 weeks
Changes in short-chain fatty acid production
Time frame: 10 times over 13 weeks
Stool frequency
Time frame: 13 week
Stool consistency according to Bristol Stool Form Scale
Time frame: 13 week
Gastrointestinal sensations (bloating)
Time frame: 13 week
Gastrointestinal sensations (flatulence)
Time frame: 13 week
Gastrointestinal sensations (abdominal pain)
Time frame: 13 week
Gastrointestinal sensations (abdominal pressure)
Time frame: 13 week
Appetite - Feeling of Fullness?
Time frame: 12 weeks
Appetite - Feeling of hunger?
Time frame: 12 weeks
Appetite - Desire to eat?
Time frame: 12 weeks
Appetite - How much food could you eat right now?
Time frame: 12 weeks
Appetite - How strong is your preoccupations with food?
Time frame: 12 weeks
Appetite - Feeling of Thirst
Time frame: 12 weeks
Appetite - Desire to eat something salty
Time frame: 12 weeks
Appetite - Desire to eat something fatty
Time frame: 12 weeks
Appetite - Desire to eat something sweet
Time frame: 12 weeks
Transient mood
Time frame: 13 weeks
Fecal and blood metabolites
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- 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.
Stephen Lindemann, PhD principal investigator
Purdue University
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 and Maltodextrin in people with Healthy, run by Purdue University at 1 site in United States.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. 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 States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Lindemann, PhD (765-494-9207, lindems@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Bifidobacterium counts in stool samples (time frame: 13 weeks). 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 11 Dec 2025.