NCT06528041 Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota
| NCT ID | NCT06528041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Purdue University |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-07-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2024-08-01 with a primary completion date of 2026-07-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * adults aged 18-45 * BMI \>18.5 - \< 30 kg/m2 * Regular bowel movements (\> 4 days per week) Exclusion Criteria: * 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. * 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.
Contact & Investigator
Stephen Lindemann, PhD
PRINCIPAL INVESTIGATOR
Purdue University
Frequently Asked Questions
Who can join the NCT06528041 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06528041 currently recruiting?
Yes, NCT06528041 is actively recruiting participants. Contact the research team at lindems@purdue.edu for enrollment information.
Where is the NCT06528041 trial being conducted?
This trial is being conducted at West Lafayette, United States.
Who is sponsoring the NCT06528041 clinical trial?
NCT06528041 is sponsored by Purdue University. The principal investigator is Stephen Lindemann, PhD at Purdue University. The trial plans to enroll 52 participants.