Inulin for Healthy Subjects

Overseen By Stephen Lindemann, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Disqualifiers: FODMAP sensitivity, Food allergies, Antibiotics, Gastrointestinal disease, Psychiatric disorders, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

52 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{5 6 8 9 10}

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

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

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

Group I: Pure Inulin Experimental Treatment 1 Intervention

12 g/day prebiotic supplement

Group II: Placebo Placebo Group 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Inulin-type fructans, such as Chicory inulin and agave inulin, demonstrated significant anticancer effects by inhibiting colon cancer development in mice, reducing inflammation markers, and preventing intestinal damage.

Inulin treatments improved bone density in ovariectomized rats without causing adverse biochemical changes, suggesting its potential as a prebiotic for enhancing calcium absorption and preventing osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Effects of Prebiotic Fructans in Colon Cancer and Calcium Metabolism in Animal Models. Rivera-Huerta, M., Lizárraga-Grimes, VL., Castro-Torres, IG., et al.[2018]

Chicory-derived inulin-type fructans, consumed at doses of 3-20 g/day, significantly increase the abundance of beneficial gut bacteria, specifically Bifidobacterium, in a diverse population of 2525 participants across 50 studies.

These fructans not only promote gut health by enhancing Bifidobacterium levels but also improve bowel function in healthy individuals, although their effects were less pronounced in those with gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of chicory-derived inulin-type fructans on abundance of Bifidobacterium and on bowel function: a systematic review with meta-analyses. Nagy, DU., Sándor-Bajusz, KA., Bódy, B., et al.[2022]

Inulin-type fructans, particularly oligofructose-enriched inulin, are effective prebiotics that enhance gut health by promoting the growth of beneficial bacteria and improving bowel habits, supported by numerous animal studies and human trials.

Inulin has been shown to reduce triglyceride levels in the blood and may help normalize blood lipids, with potential implications for reducing the risk of colon cancer, as ongoing human trials are investigating its effects in individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing inulin-type fructans. Roberfroid, MB.[2021]

In a study involving 45 volunteers, the consumption of snack bars containing chicory inulin (CH) or Jerusalem artichoke inulin (JA) for 21 days significantly increased beneficial bifidobacteria levels while reducing certain potentially harmful bacteria, indicating a positive effect on gut health.

Participants experienced a slight increase in stool frequency and some mild gastrointestinal symptoms, such as flatulence, suggesting that while CH and JA can promote beneficial gut bacteria, they may also cause some digestive discomfort in a few individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jerusalem artichoke and chicory inulin in bakery products affect faecal microbiota of healthy volunteers. Kleessen, B., Schwarz, S., Boehm, A., et al.[2023]

Fructo-oligosaccharides (FOS) are prebiotics that resist digestion in the upper gastrointestinal tract and are fermented in the colon, leading to the production of beneficial short-chain fatty acids and an increase in healthy gut bacteria, particularly bifidobacteria.

In addition to their prebiotic effects, inulin-type fructans have a low caloric value, improve calcium absorption, and may help reduce triglyceride levels, suggesting potential health benefits that warrant further investigation in human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fructo-oligosaccharide malabsorption: benefit for gastrointestinal functions. Roberfroid, MB.[2019]

Inulin-type fructans from chicory roots have been shown to significantly reduce the incidence of pre-neoplastic lesions and tumors in animal studies, with 21 out of 24 treatment groups showing reduced aberrant crypt foci (ACF) and all 5 groups measuring tumors showing reduced incidence.

The protective effects against colon cancer are linked to the fermentation of inulin-type fructans in the gut, leading to the production of beneficial compounds like butyrate, which inhibit tumor cell growth and promote healthier gut flora.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin-type fructans and reduction in colon cancer risk: review of experimental and human data. Pool-Zobel, BL.[2022]

Chicory inulin significantly enhances digestive fermentation and mineral absorption, particularly calcium and magnesium, in growing rats, with notable effects observed after one month of adaptation.

The study found that while both purified and reformulated inulin improved cecal fermentation and mineral absorption, the crude chicory diet had superior effects on bone density and strength, suggesting potential synergistic benefits from the whole food source.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of native or reformulated chicory fructans, or non-purified chicory, on rat cecal fermentation and mineral metabolism. Demigné, C., Jacobs, H., Moundras, C., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of dietary oligofructose and inulin on colonic preneoplastic aberrant crypt foci inhibition. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerance to an inulin-rich soluble roasted chicory extract after consumption in healthy subjects. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Functional Effects of Prebiotic Fructans in Colon Cancer and Calcium Metabolism in Animal Models. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of chicory-derived inulin-type fructans on abundance of Bifidobacterium and on bowel function: a systematic review with meta-analyses. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Introducing inulin-type fructans. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Jerusalem artichoke and chicory inulin in bakery products affect faecal microbiota of healthy volunteers. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Fructo-oligosaccharide malabsorption: benefit for gastrointestinal functions. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Inulin-type fructans and reduction in colon cancer risk: review of experimental and human data. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Comparison of native or reformulated chicory fructans, or non-purified chicory, on rat cecal fermentation and mineral metabolism. [2023]