Soluble Fiber for Asthma

Overseen By Daniel Gastaldo

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the soluble fiber supplement, NOVELOSETM 3490, can improve asthma by affecting the gut. Participants will receive either the fiber supplement or a placebo, and researchers will study their gut microbes to assess the fiber's impact on asthma. The trial seeks children and teens aged 6-17 who have been diagnosed with asthma in the last two years and have environmental allergies or high levels of a specific exhaled gas. Participants must not have had recent ER visits and should be able to consume a fiber supplement or placebo. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important asthma research.

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.

Is there any evidence suggesting that NOVELOSETM 3490 is likely to be safe for humans?

Research shows that NOVELOSE™ 3490 is a type of resistant starch made from tapioca. Studies have found that people generally tolerate it well. Monash University has certified it as Low FODMAP, indicating it is less likely to cause digestive issues like bloating or gas, which are common with other fibers.

Additionally, the FDA has recognized resistant dextrin from tapioca, such as NOVELOSE™ 3490, as safe when used as a dietary fiber in certain amounts in food. This approval confirms its safety for consumption under specific conditions. While individual reactions can vary, the available data for NOVELOSE™ 3490 reports no major side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike the standard asthma treatments, which often involve inhaled corticosteroids or bronchodilators, NOVELOSETM 3490 offers a unique approach by utilizing soluble fiber. This treatment is exciting because it targets the gut microbiome, aiming to modulate immune responses that could alleviate asthma symptoms. Researchers are intrigued by the potential for dietary intervention to offer a natural, less invasive method for managing asthma, potentially improving patient outcomes while minimizing side effects associated with traditional medications.

What evidence suggests that NOVELOSETM 3490 might be an effective treatment for asthma?

Research has shown that soluble fiber might help with asthma symptoms. Some studies suggest that increasing soluble fiber intake can improve gut health, potentially reducing inflammation and aiding breathing. Early findings indicate that altering the gut microbiome (the balance of good and bad bacteria in the digestive system) through diet could impact asthma control. In this trial, participants will receive either NOVELOSETM 3490, a soluble fiber, or a placebo. Although the specific effects of NOVELOSETM 3490 are still under investigation, it is believed to promote a healthier gut, which might help manage asthma. The current data appears promising but remains in development. ^{6 7 8 9}

Who Is on the Research Team?

Matthew Rank

Principal Investigator

Phoenix Children's

Are You a Good Fit for This Trial?

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 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 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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06372249/a-clinical-trial-of-soluble-fiber-for-asthma

A Clinical Trial of Soluble Fiber for Asthma Study Summary. Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire ...

2. researchgate.net researchgate.net/publication/329849326_Tapioca_starch_powder_as_a_new_cause_of_occupational_asthma_in_bakers

Tapioca starch powder as a new cause of occupational ... A novel vilanterol/fluticasone furoate (VI/FF) combination is a highly effective combination for maintenance treatment of moderate to severe asthma with 24-hour ...

3. withpower.com withpower.com/guides/inside-why-does-corn-not-digest

Inside Why Does Corn Not Digest | Power Dietary fiber is categorized into two types: soluble and insoluble. Soluble fiber dissolves in water to form a gel-like substance, slowing down the digestion ...

4. icens.eu icens.eu/sites/default/files/2016/Chapter_5_checked_ABD.pdf

based Super Alloy Haynes 25 under Cryogenic Cooling This study focuses on an experimental investigation for determining surface roughness during turning of cobalt based super alloy Haynes 25.

5. ingredion.com ingredion.com/content/dam/ingredion/technical-documents/apac/NOVELOSE%203490%20(06400300)%20Technical%20Specification,%20v1.7.pdf

NOVELOSE 3490 (06400300) Technical Specification, ... NOVELOSE® 3490 is a modified food starch based on tapioca. NOVELOSE® 3490 can be used to increase total dietary fiber and reduce caloric content ...

6. kerrbyingredion.com kerrbyingredion.com/content/dam/ingredion/pdf-downloads/US-Assets/factsheets/NOVELOSE-3490-DietaryFiber-Factsheet-Ingredion-US-CAN-MCOM-05042020%20(1).pdf

A fiber to enrich product appeal The ingredient NOVELOSE 3490 dietary fiber is Low FODMAP Certified by Monash University. The information described above is offered solely for your ...

7. ingredion.com ingredion.com/content/dam/ingredion/technical-documents/na/Product%20Information%20File%20-%20Tapioca%20Starches.pdf

PRODUCT INFORMATION FILE – TAPIOCA STARCH The food safety management systems drive continuous improvement and encompass a food safety risk assessment and ... The exception is the Safety Data Sheet ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7092686/

Novel resistant starch type 4 products of different ... VERSFIBE™1490 (RSA), VERSFIBE™2480 (RSC), and NOVELOSE™3490 (RSD) are all distarch phosphate starches consisting of diester phosphate crosslinks between starch ...

9. fda.gov fda.gov/media/167305/download

GRAS Notice GRN 1045 Agency Response Letter The subject of the notice is resistant dextrin from tapioca for use as a source of dietary fiber at maximum levels ranging from 1.2 to 10 g per serving1 in ...