Soluble Fiber for Asthma

Overseen By Matthew Rank

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Phoenix Children's Hospital

Disqualifiers: Cystic fibrosis, Bronchiectasis, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

105 Participants Needed

Trial Summary

What is the purpose of this trial?

Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that no changes in asthma medicines, except for short-acting bronchodilators, should be planned over the next 4-6 weeks.

What data supports the effectiveness of the treatment NOVELOSETM 3490, a tapioca-based dietary fiber, for asthma?

Research suggests that dietary fibers, like those in NOVELOSETM 3490, can help manage asthma by reducing inflammation and improving asthma symptoms. Studies have shown that higher intake of dietary fiber is linked to fewer asthma symptoms and better asthma control, and soluble fiber specifically has been found to have anti-inflammatory effects in the airways. ^{1 2 3 4 5}

Is the soluble fiber treatment safe for humans?

Research on resistant starches, like those in Novelose, suggests they are generally safe and have health benefits, such as promoting gut health and reducing cancer risk in animal studies. However, consuming too much can cause digestive issues like bloating and gas. ^{6 7 8 9 10}

How is the treatment NOVELOSETM 3490 different from other asthma treatments?

NOVELOSETM 3490 is unique because it is a soluble fiber treatment that may help manage asthma by influencing the gut-lung connection, potentially reducing airway inflammation through the production of short-chain fatty acids (SCFAs) that support immune balance. Unlike traditional asthma medications that directly target the airways, this treatment focuses on dietary fiber's role in modulating the body's immune response. ^{1 2 3 6 11}

Research Team

Matthew Rank

Principal Investigator

Phoenix Children's

Eligibility Criteria

This trial is for children and adults with asthma. Participants must complete a dietary recall questionnaire to assess their fiber intake. They should be willing to take additional soluble fiber or placebo as part of the study.

Inclusion Criteria

I am between 6 and 17 years old.

No emergency department visits in the past 1 month

I was diagnosed with asthma in the last 2 years.

Exclusion Criteria

I plan to change my asthma medications soon, except for quick-relief inhalers.

I have cystic fibrosis.

Sibling of a participant already enrolled in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either soluble fiber (NOVELOSETM 3490) or placebo, with blood serum, fecal samples, and nasal wash collected for analysis

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including final stool sample collection

1 week

1 visit (virtual)

Treatment Details

Interventions

• NOVELOSETM 3490

Trial Overview The trial is testing whether adding soluble fiber (NOVELOSETM 3490) to the diet can improve asthma symptoms. It's a randomized controlled trial, meaning people are randomly assigned to receive either the fiber supplement or a placebo.

Participant Groups

Group I: Fiber Consumption and the Gut Microbiome Composition in a Pediatric Asthma Cohort Active Control 1 Intervention

Participants are asked to complete a dietary recall questionnaire (ASA 24) that evaluates dietary intake in the last 24 hours. Participants are also sent home with a stool kit and instructions to collect a fecal sample for microbiome analysis. The purpose of the study is to better understand the pathways that connect diet and asthma.

Group II: A Phase II Randomized Controlled Trial of Soluble Fiber for Asthma Placebo Group 1 Intervention

Participants are asked to fill out a dietary recall questionnaire (ASA 24) to determine eligibility in the study. If eligible, a nasal wash and blood sample will be collected at the first visit. Study drug or placebo will be given to participant after their visit in a randomized double-blinded nature. The participant will also fil out an Asthma Control Questionnaire (ACQ) and be sent home with 3 stool kits for analysis. Participant will turn in one sample after first visit, the second in three weeks, and the last one after the second study visit. At this second study visit, procedures from the first study visit will be repeated.

NOVELOSETM 3490 is already approved in United States, Canada for the following indications:

Approved in United States as NOVELOSETM 3490 for:

• Dietary fiber supplementation
• General health and wellness

Approved in Canada as NOVELOSETM 3490 for:

• Dietary fiber supplementation
• General health and wellness

Who Is Running the Clinical Trial?

Phoenix Children's Hospital

Lead Sponsor

Trials

78

Recruited

5,014,000+

Northern Arizona University

Collaborator

Trials

36

Recruited

6,300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Dietary fibers and their fermentation products, such as short-chain fatty acids, may play a significant role in managing allergic asthma by modulating immune responses, as supported by studies in mice, children, and adults.

There is a need for more large-scale dietary intervention trials to better understand the specific types of fibers, their dosages, and their potential combined effects with probiotics in preventing and treating allergic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Fibers: Effects, Underlying Mechanisms and Possible Role in Allergic Asthma Management. Verstegen, REM., Kostadinova, AI., Merenciana, Z., et al.[2021]

In a study of 35,380 participants, higher dietary fibre intake, particularly from cereals, was linked to fewer asthma symptoms and better asthma control, with significant reductions in symptom scores for both men and women.

The research indicated that individuals in the highest quintile of total dietary fibre intake had a 27% lower odds of experiencing asthma symptoms and a 28% lower odds of uncontrolled asthma compared to those in the lowest quintile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between dietary fibre intake and asthma (symptoms and control): results from the French national e-cohort NutriNet-Santé. Andrianasolo, RM., Hercberg, S., Kesse-Guyot, E., et al.[2020]

In a study involving 17 adults with stable asthma, soluble fibre supplementation (inulin) for 7 days improved asthma control and reduced airway inflammation, as indicated by decreased eosinophils and histone deacetylase 9 gene expression.

However, the supplementation did not significantly change plasma short chain fatty acid levels, suggesting that while soluble fibre may benefit asthma management, its mechanism may not involve SCFA modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble fibre supplementation with and without a probiotic in adults with asthma: A 7-day randomised, double blind, three way cross-over trial. McLoughlin, R., Berthon, BS., Rogers, GB., et al.[2020]

A diet containing a mixture of short-chain and long-chain fructo-oligosaccharides combined with Bifidobacterium breve M-16V significantly reduced allergic airway inflammation in a mouse model of house dust mite-induced asthma.

The synbiotic combination (FFBB) effectively lowered the levels of inflammatory markers and immune cells associated with allergic responses, demonstrating its potential as a preventive strategy against allergic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of allergic inflammation in a murine house dust mite asthma model is suppressed by synbiotic mixtures of non-digestible oligosaccharides and Bifidobacterium breve M-16V. Verheijden, KA., Willemsen, LE., Braber, S., et al.[2018]

In a pilot study involving 29 adults with stable asthma, a single dose of soluble fibre significantly reduced airway inflammation markers, such as exhaled nitric oxide and interleukin-8, compared to a control meal.

The reduction in inflammation was associated with increased gene expression of free fatty acid receptors GPR41 and GPR43, suggesting that soluble fibre may have acute anti-inflammatory effects in asthma that could be explored for long-term therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble Fibre Meal Challenge Reduces Airway Inflammation and Expression of GPR43 and GPR41 in Asthma. Halnes, I., Baines, KJ., Berthon, BS., et al.[2021]

In a study involving 24 healthy participants, both forms of resistant starch (RS2 and RS3) increased fecal bulk compared to a low-fiber control, suggesting they can enhance digestive health.

The resistant starches also significantly increased the fecal butyrate:SCFA ratio, which is beneficial for colonic health, without affecting blood lipids or glycemic indices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index. Jenkins, DJ., Vuksan, V., Kendall, CW., et al.[2019]

Nonstarch polysaccharides (NSPs) have beneficial health effects, such as reducing the risk of diet-related diseases like coronary heart disease and Type 2 diabetes, due to their properties like water dispersibility and fermentability into short chain fatty acids (SCFAs).

Insoluble NSPs act as effective laxatives, while soluble NSPs help lower cholesterol and normalize blood glucose levels, making them valuable in dietary plans for managing cardiovascular health and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary roles of non-starch polysaccharides in human nutrition: a review. Kumar, V., Sinha, AK., Makkar, HP., et al.[2019]

Annealing and heat-moisture treatment (HMT) can significantly increase the yield of resistant starch type 3 (RS3) from Novelose 330 by up to 75%, enhancing its thermal stability and crystallinity, which makes it suitable for various applications.

In an in vivo study with Wistar rats, HMT-Novelose led to higher butyrate concentrations in the distal colon and more effective suppression of secondary bile acids compared to standard Novelose 330, indicating its potential as a health-promoting prebiotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrothermal treatment of Novelose 330 results in high yield of resistant starch type 3 with beneficial prebiotic properties and decreased secondary bile acid formation in rats. Jacobasch, G., Dongowski, G., Schmiedl, D., et al.[2019]

In a study involving 20 Sprague-Dawley rats, a diet containing 10% resistant starch type 3 (RS3) completely prevented tumor development compared to a standard diet, which resulted in tumor formation.

The RS3 diet led to reduced cell proliferation and increased apoptosis in the distal colon, suggesting that RS3 may protect against colon cancer by promoting the death of potentially cancerous cells and altering the expression of key proteins involved in tumor development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary resistant starch type 3 prevents tumor induction by 1,2-dimethylhydrazine and alters proliferation, apoptosis and dedifferentiation in rat colon. Bauer-Marinovic, M., Florian, S., Müller-Schmehl, K., et al.[2013]

Nondigestible carbohydrates (NDCs), which include various dietary fibers, have specific tolerable intake levels that vary by type, with recommendations ranging from 3.75 g/d for alginate to 25 g/d for soy fiber, based on a review of 103 clinical trials involving adults without gastrointestinal disease.

Overconsumption of NDCs can lead to gastrointestinal side effects, highlighting the need for clear guidelines on their intake to help bridge the gap between actual and recommended fiber consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal Effects and Tolerance of Nondigestible Carbohydrate Consumption. Mysonhimer, AR., Holscher, HD.[2023]

A diet rich in oat-based products significantly reduced serum total cholesterol levels in Wistar rats, indicating potential heart health benefits from dietary fiber and resistant starch.

The oat-based diets increased beneficial gut bacteria (bifidobacteria) and short-chain fatty acids (SCFAs) while decreasing harmful coliforms, suggesting improved gut health and digestion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fibre-rich oat-based products affect serum lipids, microbiota, formation of short-chain fatty acids and steroids in rats. Drzikova, B., Dongowski, G., Gebhardt, E.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Fibers: Effects, Underlying Mechanisms and Possible Role in Allergic Asthma Management. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Association between dietary fibre intake and asthma (symptoms and control): results from the French national e-cohort NutriNet-Santé. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Soluble fibre supplementation with and without a probiotic in adults with asthma: A 7-day randomised, double blind, three way cross-over trial. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

The development of allergic inflammation in a murine house dust mite asthma model is suppressed by synbiotic mixtures of non-digestible oligosaccharides and Bifidobacterium breve M-16V. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Soluble Fibre Meal Challenge Reduces Airway Inflammation and Expression of GPR43 and GPR41 in Asthma. [2021]

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

Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index. [2019]

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

Dietary roles of non-starch polysaccharides in human nutrition: a review. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Hydrothermal treatment of Novelose 330 results in high yield of resistant starch type 3 with beneficial prebiotic properties and decreased secondary bile acid formation in rats. [2019]

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

Dietary resistant starch type 3 prevents tumor induction by 1,2-dimethylhydrazine and alters proliferation, apoptosis and dedifferentiation in rat colon. [2013]

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

Gastrointestinal Effects and Tolerance of Nondigestible Carbohydrate Consumption. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Dietary fibre-rich oat-based products affect serum lipids, microbiota, formation of short-chain fatty acids and steroids in rats. [2019]