Inulin for Healthy Subjects
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have any conditions or are taking medications related to the exclusion criteria, it might affect your eligibility.
What data supports the effectiveness of the treatment Inulin for Healthy Subjects?
Research shows that chicory-derived inulin-type fructans can increase the growth of beneficial gut bacteria and improve bowel function in healthy people. These fructans also have potential health benefits like enhancing calcium absorption and reducing inflammation, which may help prevent chronic diseases.12345
Is inulin safe for human consumption?
Inulin, a type of dietary fiber found in chicory, is generally considered safe for human consumption. Studies show it can promote the growth of beneficial gut bacteria and improve bowel function without significant adverse effects. It is used as a prebiotic to support gut health and has been shown to have potential health benefits, such as enhancing calcium absorption and reducing the risk of colon cancer.14567
How does the treatment Native Chicory Inulin differ from other treatments for improving gut health?
Native Chicory Inulin is unique because it is a prebiotic dietary fiber that resists digestion in the upper gastrointestinal tract and is fermented in the colon, promoting the growth of beneficial bacteria like Bifidobacterium. This fermentation process produces short-chain fatty acids that improve bowel function and may reduce the risk of colon cancer, making it different from other treatments that do not have these specific prebiotic and fermentation-related benefits.568910
What is the purpose of 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.
Research Team
Stephen Lindemann, PhD
Principal Investigator
Purdue University
Eligibility Criteria
This trial is for healthy adults interested in how a natural fiber, native chicory inulin, affects their gut bacteria compared to maltodextrin, a placebo. Participants will take supplements for 6 weeks and track changes in digestion, mood, and appetite.Inclusion Criteria
Exclusion Criteria
Timeline
Run-in
Participants complete a one-week run-in phase to establish baseline data
Supplementation
Participants are allocated to either native chicory inulin or maltodextrin supplementation
Post-supplementation
Participants are monitored for changes in gut microbiota and other health parameters after stopping supplementation
Follow-up
Participants are monitored for safety and effectiveness after the main phases
Treatment Details
Interventions
- Maltodextrin
- Native Chicory Inulin
Native Chicory Inulin is already approved in European Union, United States for the following indications:
- Maintenance of normal defecation by increasing stool frequency
- Prebiotic effects
- Dietary fiber supplement
- Prebiotic effects
Find a Clinic Near You
Who Is Running the Clinical Trial?
Purdue University
Lead Sponsor