Fiber Inulin for Chronic Obstructive Pulmonary Disease

Overseen By Marielle M Engelen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Must not be taking: Oral corticosteroids

Disqualifiers: Diabetes, Malignancy, Metabolic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a fiber supplement called inulin affects individuals with chronic obstructive pulmonary disease (COPD), a condition that makes breathing difficult. Researchers aim to determine if inulin alters the production of certain substances in the body, known as short chain fatty acids (SCFAs). The study will compare individuals with COPD to healthy individuals without breathing problems. Candidates may qualify if they have COPD, experience shortness of breath during activity, and have not had a recent respiratory infection. As an unphased study, this trial provides a unique opportunity to contribute to understanding COPD and potentially improve future treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have used oral corticosteroids within 4 weeks before the study or if you take daily fiber supplements 1 week before the first test day.

What prior data suggests that this protocol is safe for COPD patients?

Previous studies have shown that inulin is generally safe and well-tolerated. Most people can take up to 20 grams daily without issues. Some might experience mild digestive problems like bloating or gas, but these are not serious. Inulin, a type of dietary fiber, aids digestion by supporting beneficial gut bacteria. Research also suggests that inulin might benefit lung health, offering promise for those with chronic obstructive pulmonary disease (COPD). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Chronic Obstructive Pulmonary Disease (COPD), which often focus on bronchodilators and steroids to open airways and reduce inflammation, inulin offers a novel approach by targeting gut health. Inulin is a type of dietary fiber that promotes the growth of beneficial gut bacteria, which may have a positive impact on inflammation and immune function. Researchers are excited about inulin because it could provide a natural, dietary-based option with fewer side effects, potentially improving overall health and quality of life for COPD patients.

What evidence suggests that inulin might be an effective treatment for COPD?

This trial will investigate the effects of inulin, a type of dietary fiber, on individuals with Chronic Obstructive Pulmonary Disease (COPD) and healthy participants. Research has shown that inulin might benefit people with COPD. Studies have found that dietary fiber like inulin can improve gut health by reducing inflammation and affecting gut bacteria. One study discovered that increased fiber intake was linked to a lower risk of dying from respiratory diseases. Additionally, inulin has protected against certain types of colon damage. These findings suggest that inulin could improve health outcomes in COPD patients by supporting better gut health and reducing inflammation. ^{1 2 3 6 7}

Who Is on the Research Team?

Marielle Engelen

Principal Investigator

Texas A&M University - CTRAL

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to lay in supine or elevated position for 1.5 hours

Ability to walk, sit down and stand up independently

Age 45 - 100 years

Exclusion Criteria

You had a fever in the past three days.

You have taken oral corticosteroids for a short period of time within the past 4 weeks before the study.

You have been taking fiber supplements every day for a week before the first test day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive fiber supplementation or placebo to study changes in SCFA metabolism

5 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inulin
• Maltodextrin

How Is the Trial Designed?

Group I: Healthy Young Participants Experimental Treatment 2 Interventions

healthy young subjects with age 18-30 years old

Group II: Healthy Participants Experimental Treatment 2 Interventions

healthy control subjects

Group III: Chronic Obstructive Pulmonary Disease patients Experimental Treatment 2 Interventions

Established diagnosis of Chronic Obstructive Pulmonary Disease

Inulin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Inulin for:

• Dietary supplement
• Prebiotic

Approved in United States as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Canada as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Japan as Inulin for:

• Dietary supplement
• Prebiotic

Approved in China as Inulin for:

• Dietary supplement
• Prebiotic

Approved in Switzerland as Inulin for:

• Dietary supplement
• Prebiotic

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

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]

In a study using fecal cultures from healthy and morbidly obese adults, different prebiotics were tested, revealing that 1-kestose had the most significant impact on gut microbiota composition and metabolic activity.

Prebiotic modulation led to increased Bacteroides and Faecalibacterium in obese individuals, while normal-weight individuals showed higher levels of Bifidobacterium and Faecalibacterium, highlighting the need for tailored prebiotic treatments based on individual microbiota profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. Nogacka, AM., Salazar, N., Arboleya, S., et al.[2023]

Inulin acts as a prebiotic that enhances the growth of beneficial Bifidobacterium bacteria and produces short-chain fatty acids (SCFAs) through fermentation, which can help prevent or treat metabolic disorders like obesity and type 2 diabetes.

While inulin has many health benefits, it can also cause gastrointestinal issues in some individuals, highlighting the need for careful dosage and further research on its long-term use and interactions with medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin fructans in diet: Role in gut homeostasis, immunity, health outcomes and potential therapeutics. Tawfick, MM., Xie, H., Zhao, C., et al.[2022]

Inulin-type fructans (ITF) have been shown to positively influence the intestinal microbiota by increasing beneficial bacteria such as Bifidobacterium and Lactobacillus, which can lead to improved gut health and function.

ITF intake is associated with several health benefits, including better intestinal barrier function, improved insulin sensitivity, lower triglycerides, enhanced mineral absorption, and increased feelings of fullness, although more research is needed to understand how chain length affects these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prebiotic Potential of Inulin-Type Fructans: A Systematic Review. Hughes, RL., Alvarado, DA., Swanson, KS., et al.[2023]

Higher dietary fiber intake is associated with numerous health benefits, including reduced risk of cardiovascular disease, improved gut health, and lower body weights, with oligosaccharides now recognized as part of dietary fiber due to their physiological effects.

Oligosaccharides, such as inulin and fructo-oligosaccharides, are effective prebiotics that promote the growth of beneficial gut bacteria like Bifidobacterium, contributing to overall well-being and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiber and prebiotics: mechanisms and health benefits. Slavin, J.[2022]

The combination of prebiotic galacto-oligosaccharides (GOS) and inulin significantly reduced the formation of aberrant crypt foci (ACF) by 55.8% in a rodent model of colorectal cancer, indicating a strong preventive effect against cancer development.

This study suggests that the novel combination of GOS and inulin is more effective than either treatment alone, enhancing short-chain fatty acid production and bacterial enzymatic activities, which may contribute to its chemopreventive properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Combination of Prebiotics Galacto-Oligosaccharides and Inulin-Inhibited Aberrant Crypt Foci Formation and Biomarkers of Colon Cancer in Wistar Rats. Qamar, TR., Syed, F., Nasir, M., et al.[2018]

Inulin fructans, derived from chicory root, are safe and well-tolerated dietary fibers that can be consumed up to 20 g per day, providing various health benefits.

They have direct effects on gut health, such as improving bowel function and promoting beneficial gut bacteria, as well as indirect effects on blood lipids and the immune system, suggesting potential for further research in energy balance and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of Inulin Fructans in the Human Diet. Schaafsma, G., Slavin, JL.[2021]

In a study involving 30 obese women over 3 months, treatment with inulin-type fructans (ITF prebiotics) significantly altered gut microbiota composition, increasing beneficial bacteria like Bifidobacterium and Faecalibacterium prausnitzii, which are linked to lower serum lipopolysaccharide levels.

The ITF prebiotics also resulted in a slight decrease in fat mass and changes in plasma metabolites, suggesting that these prebiotics can modestly influence host metabolism and may have implications for obesity and diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. Dewulf, EM., Cani, PD., Claus, SP., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12145321/

Characterizing gut microbial dysbiosis and exploring the ... This study aimed to assess altered gut microbiota composition in patients with COPD and to explore the effects of targeted multi-nutrient supplementation ...

2. withpower.com withpower.com/trial/phase-lung-diseases-obstructive-5-2020-a3e9c

Fiber Inulin for Chronic Obstructive Pulmonary Disease The study suggests that ITF may help improve gut health in obese individuals by decreasing inflammation and potentially influencing gut microbiota-derived ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10420973/

Plant-Based Dietary Fibers and Polysaccharides as ... The study reported that the consumption of dietary fiber was associated with a reduced risk of mortality from respiratory diseases in both men ...

4. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jafc.3c03432

Exploring the Role of Inulin in Targeting the Gut Microbiota In this study, we establish the efficacy of inulin supplements in safeguarding against colonic fibrosis caused by irradiation therapy.

5. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1549865/full

Chronic obstructive pulmonary disease: in-depth analysis ... The pathogenesis of chronic obstructive pulmonary disease (COPD) is complex and affects multiple systems. This article focuses on COPD and elaborates on the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02872675

Study Details | The Effects of Prebiotics on Gut Bacterial ... The current study aims to explore the role of prebiotic supplementation in adults with and without Asthma/Exercise-Induced Bronchoconstriction (A/EIB).

7. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/ncp.11329

Medical nutrition therapy in chronic obstructive pulmonary ... As such, it is imperative to have detailed body composition data to foresee possible health risks and complications. COPD PHENOTYPES. A COPD ...