52 Participants Needed

Inulin for Healthy Subjects

PJ
SL
Overseen ByStephen Lindemann, PhD
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

SL

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

BMI >18.5 - <30 kg/m2
Regular bowel movements (>4 days per week)

Exclusion Criteria

I have a history of heart, liver, lung diseases, cancer, or diabetes.
Self-reported food allergies and sensitivities including gluten, dairy, nuts, soya, and lactose etc.
Self-reported smoking and/or self-reported drug or alcohol abuse
See 6 more

Timeline

Run-in

Participants complete a one-week run-in phase to establish baseline data

1 week
1 visit (in-person)

Supplementation

Participants are allocated to either native chicory inulin or maltodextrin supplementation

6 weeks
Regular sample collection visits

Post-supplementation

Participants are monitored for changes in gut microbiota and other health parameters after stopping supplementation

6 weeks
Regular sample collection visits

Follow-up

Participants are monitored for safety and effectiveness after the main phases

4 weeks

Treatment Details

Interventions

  • Maltodextrin
  • Native Chicory Inulin
Trial Overview The study tests the impact of chicory inulin on gut microbiota against maltodextrin. It measures how quickly and persistently the gut bacteria change with daily supplementation over six weeks and observes these effects after stopping the supplement.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pure InulinExperimental Treatment1 Intervention
12 g/day prebiotic supplement
Group II: PlaceboPlacebo Group1 Intervention
6 g/day maltodextrin

Native Chicory Inulin is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Native Chicory Inulin for:
  • Maintenance of normal defecation by increasing stool frequency
  • Prebiotic effects
🇺🇸
Approved in United States as Native Chicory Inulin for:
  • Dietary fiber supplement
  • Prebiotic effects

Find a Clinic Near You

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials
239
Recruited
72,200+

Findings from Research

In a study involving male F344 rats, feeding oligofructose or inulin significantly reduced the formation of aberrant crypt foci (ACF), which are early indicators of potential colon cancer.
Inulin was found to be more effective than oligofructose in inhibiting ACF formation, suggesting that chicory fructans may play a protective role against colon carcinogenesis.
Effect of dietary oligofructose and inulin on colonic preneoplastic aberrant crypt foci inhibition.Reddy, BS., Hamid, R., Rao, CV.[2019]
In a study involving 18 healthy subjects, short-term consumption of a chicory extract containing inulin showed a slight increase in gastrointestinal discomfort at the higher dose, but overall, it was well tolerated.
In a longer study with 35 subjects, long-term consumption of the chicory extract did not result in significant gastrointestinal symptoms compared to a control, indicating that it is safe for regular use at a dose of 5 g of inulin per day.
Gastrointestinal tolerance to an inulin-rich soluble roasted chicory extract after consumption in healthy subjects.Ripoll, C., Flourié, B., Megnien, S., et al.[2023]
In a 3-month randomized, placebo-controlled trial involving 24 obese patients, the intake of inulin-type fructans (ITF) significantly increased levels of beneficial gut bacteria, specifically Bifidobacterium, and reduced fecal calprotectin, a marker of gut inflammation.
The study suggests that ITF may help improve gut health in obese individuals by decreasing inflammation and potentially influencing gut microbiota-derived metabolites, although it did not significantly change short-chain fatty acid levels.
Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial.Neyrinck, AM., Rodriguez, J., Zhang, Z., et al.[2022]

References

Effect of dietary oligofructose and inulin on colonic preneoplastic aberrant crypt foci inhibition. [2019]
Gastrointestinal tolerance to an inulin-rich soluble roasted chicory extract after consumption in healthy subjects. [2023]
Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial. [2022]
Functional Effects of Prebiotic Fructans in Colon Cancer and Calcium Metabolism in Animal Models. [2018]
Effect of chicory-derived inulin-type fructans on abundance of Bifidobacterium and on bowel function: a systematic review with meta-analyses. [2022]
Introducing inulin-type fructans. [2021]
Jerusalem artichoke and chicory inulin in bakery products affect faecal microbiota of healthy volunteers. [2023]
Fructo-oligosaccharide malabsorption: benefit for gastrointestinal functions. [2019]
Inulin-type fructans and reduction in colon cancer risk: review of experimental and human data. [2022]
Comparison of native or reformulated chicory fructans, or non-purified chicory, on rat cecal fermentation and mineral metabolism. [2023]
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