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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how native chicory inulin, a type of fiber, affects the gut microbiota—the community of beneficial bacteria in the gut—in healthy adults. Researchers aim to determine the speed and duration of changes in gut bacteria when participants take inulin compared to a placebo. Participants will consume inulin or a placebo for six weeks, then stop, while researchers monitor changes in gut bacteria, mood, and appetite. Individuals with regular bowel movements and no recent antibiotic use may be suitable for this study. As an unphased trial, this study provides a unique opportunity to advance scientific understanding of dietary fibers and gut health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that native chicory inulin is generally safe for people. In several studies, participants who consumed at least 12 grams daily of this prebiotic (a type of fiber that nourishes beneficial gut bacteria) reported increased bowel movements. This indicates that the body handles inulin well. These studies, involving 86 participants, found no major safety issues. The research primarily focused on inulin's impact on gut health, yielding positive results. Although side effects weren't specifically mentioned, the consistent findings suggest participants tolerated it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for digestive health that often rely on probiotics or dietary adjustments, the study treatment uses Native Chicory Inulin, a prebiotic supplement. This prebiotic works by selectively feeding beneficial gut bacteria, potentially promoting a healthier gut environment. Researchers are excited because inulin is derived from natural sources and could offer an easy, daily supplement option that supports gut health in a gentle way. This approach might provide a more sustainable and natural alternative to traditional digestive aids.

What evidence suggests that native chicory inulin is effective for gut microbiota changes?

This trial will compare the effects of Native Chicory Inulin with a placebo. Research has shown that chicory inulin benefits gut health. Studies have found that this fiber from chicory helps balance gut bacteria, improves intestinal health, and supports regular bowel movements. Evidence also suggests that chicory inulin may aid in weight management by reducing body weight and waist size. Additionally, it has been linked to better insulin sensitivity, which can help control blood sugar levels. Overall, chicory inulin appears promising for supporting a healthy gut and improving certain metabolic factors. ^{5 6 7 8 9}

Who Is on the Research Team?

Stephen Lindemann, PhD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

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

Self-reported food allergies and sensitivities including gluten, dairy, nuts, soya, and lactose etc.

I have a history of heart, liver, lung diseases, cancer, or diabetes.

Self-reported smoking and/or self-reported drug or alcohol abuse

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39313030/

The effects of chicory inulin-type fructans supplementation ... Conclusions: Chicory ITF supplementation may benefit weight management by reducing body weight, BMI, fat mass, waist circumference, and, to a certain extent, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322000746

The Prebiotic Potential of Inulin-Type Fructans Beneficial health effects reported following ITF intake include improved intestinal barrier function, improved laxation, increased insulin sensitivity, ...

3. tandfonline.com tandfonline.com/doi/abs/10.1080/09168451.2020.1749553

Comparison of the prebiotic properties of native chicory ... These results suggest that NIN and SIN exhibit different prebiotic properties due to differences in DP, and that NIN might be more beneficial to ...

4. withpower.com withpower.com/trial/phase-healthy-subjects-hs-7-2024-2a399

Inulin for Healthy Subjects This trial is for healthy adults interested in how a natural fiber, native chicory inulin, affects their gut bacteria compared to maltodextrin, a placebo.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05447481

Evaluation of the Effect of Chicory Inulin-type Fructans in ... Interventional Model Description: This was a randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of chicory inulin-type ...

6. univarsolutions.com univarsolutions.com/frutafit-iq-bag105-16211400?srsltid=AfmBOoqKU0wz0kPUqWThzRPjinNeMdvaNG6-SWYGxGZN3I0NxCFI_5vP

FRUTAFIT IQ Frutafit IQ is a native inulin extracted from chicory roots. It is an agglomerated powder resulting in an excellent dispersibility and wettability.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8970830/

The Prebiotic Potential of Inulin-Type Fructans Beneficial health effects reported following ITF intake include improved intestinal barrier function, improved laxation, increased insulin sensitivity, ...

8. efsa.europa.eu efsa.europa.eu/en/efsajournal/pub/3951

“Native chicory inulin” and maintenance of normal defecation Six studies involving 86 subjects consistently showed that consumption of “native chicory inulin” at an amount of at least 12 g/day increases stool frequency.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1756464622000573

Food for thought! Inulin-type fructans: Does the food matrix ... The study design was a double-blind placebo controlled trial in which native chicory inulin supplemented at 15 g/day (2x7.5 g/sachets) was consumed in ...