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

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing inulin, a type of dietary fiber, in patients with COPD. The goal is to see if fiber can help improve their condition by being broken down into substances that reduce inflammation and support the immune system. Inulin has been studied for its potential benefits in managing type 2 diabetes mellitus, including improving glycemic control and antioxidant status.

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.

Is inulin safe for human consumption?

Inulin is generally considered safe and well-tolerated in humans up to 20 grams per day, although some people may experience mild digestive symptoms. It is used as a dietary fiber in many foods and has beneficial effects on gut health, but it may cause gastrointestinal symptoms in some individuals and exacerbate inflammatory bowel disease in mice. ^{1 2 3 4 5}

How does the treatment Inulin differ from other treatments for Chronic Obstructive Pulmonary Disease?

Inulin is a prebiotic fiber that promotes the growth of beneficial gut bacteria, which may help reduce inflammation, unlike traditional COPD treatments that primarily focus on improving lung function and relieving symptoms. This unique approach targets gut health to potentially influence overall inflammation in the body. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Inulin, Fructo-oligosaccharides, Prebiotic fiber, Maltodextrin, Maltodextrin powder, Dextrin, Maltodextrin DE for Chronic Obstructive Pulmonary Disease?

Research shows that inulin-type fructans, a component of the treatment, can improve gut health by promoting beneficial bacteria and reducing inflammation, which might indirectly support overall health in conditions like COPD. ^{3 4 10 11 12}

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]

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]

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]

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 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 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]

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]

Citations

1. 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]

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

The Prebiotic Potential of Inulin-Type Fructans: A Systematic Review. [2023]

3. Switzerland 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. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prebiotic Dietary Fiber and Gut Health: Comparing the in Vitro Fermentations of Beta-Glucan, Inulin and Xylooligosaccharide. [2023]

5. Switzerland 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. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Inulin fructans in diet: Role in gut homeostasis, immunity, health outcomes and potential therapeutics. [2022]

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

Significance of Inulin Fructans in the Human Diet. [2021]

8. England 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. [2022]

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

Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Fiber and prebiotics: mechanisms and health benefits. [2022]

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

Inulin and oligofructose as dietary fiber: a review of the evidence. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Chicory inulin does not increase stool weight or speed up intestinal transit time in healthy male subjects. [2023]