Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

Nutritional Therapy for Asthma
(AIR Trial)

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The Cleveland Clinic

Disqualifiers: Diabetes, Milk allergies, Coconut allergies, others

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Low Caloric Shake, Nutritional approach for asthma, Whole Lung Allergen Challenge for asthma?

Research suggests that a healthy diet, including increased intake of plant-based foods, fruits, and vegetables, may improve asthma symptoms and lung function by reducing inflammation and oxidative stress. Additionally, an interdisciplinary approach to nutrition has shown improvements in lung function in obese asthmatic adolescents.¹ ² ³ ⁴ ⁵

Is nutritional therapy for asthma safe for humans?

The studies suggest that dietary interventions, such as improving diet quality and reducing calorie intake, are generally safe and can lead to improvements in lung function and asthma control, especially in obese individuals.¹ ² ³ ⁶ ⁷

How does nutritional therapy differ from other asthma treatments?

Nutritional therapy for asthma is unique because it focuses on dietary changes, such as increasing fruits and vegetables and reducing animal products, to manage asthma symptoms by reducing inflammation and improving immune responses. Unlike traditional asthma treatments that often involve medications, this approach uses food to potentially improve lung function and overall health.¹ ² ⁴ ⁶ ⁸

What is the purpose of this trial?

The overall goal of the Asthma Inflammation Research \[AIR\] Translational Program is to create an integrated multidisciplinary team for the focused purpose of development of diagnostic and prognostic tests informative for airway inflammation, and for the design of innovative, targeted biologic therapeutics.The overarching aims of the AIR program are to conceptualize, develop, and test the next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will allow us to improve the standard of asthma care.

Research Team

Serpil Erzurum, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for people with asthma diagnosed by a specialist, who have had a positive methacholine test or significant improvement in lung function after treatment. Participants must be able to give informed consent and maintain a special diet. Smokers, those with coconut or milk allergies, diabetes, severe obesity, or serious heart/kidney diseases cannot join.

Inclusion Criteria

Your FEV1 (a measure of lung function) is at a level considered acceptable for the study.

Informed Consent is present

I have been diagnosed with asthma by a specialist.

Exclusion Criteria

I currently smoke or have smoked more than 10 pack-years.

You are allergic to coconuts.

My fasting blood sugar is above 110 mg/dL.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary interventions including medium chain triglyceride and placebo comparators

24 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Low Caloric Shake
Nutritional approach for asthma
Whole Lung Allergen Challenge

Trial Overview The AIR program aims to improve asthma care by testing new treatments and tools for diagnosis and prognosis. This includes nutritional approaches like low-calorie shakes and whole lung allergen challenges to manage both non-allergic and allergic asthma.

Participant Groups

4Treatment groups

Active Control

Placebo Group

Group I: Nutritional Approach for AsthmaActive Control1 Intervention

individuals will be provide a pre measured dose of medium chain triglyceride to consume along with their meals. They will be instructed to add the MCT to their meal 3 times per day

Group II: Whole Lung Allergen ChallengeActive Control1 Intervention

patients with or without asthma will be given controlled doses of specified allergens

Group III: Alternate Day DietActive Control1 Intervention

patients will consume a regular "Standard American Diet" for 4 weeks and then provided a regulated dosed quantity of low caloric value "shakes". they will consume this on alternating days

Group IV: Standard American DietPlacebo Group1 Intervention

patients will consume their usual diet with a pre measured dose of canola oil in place of the medium chain triglyceride as a control group. They will be instructed to add the placebo dose to their meal 3 times a day

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

A 6-month DASH dietary intervention improved diet quality and asthma control in 90 adults with uncontrolled asthma, showing a significant difference in Asthma Control Questionnaire scores compared to the usual-care control group.

While the improvements in asthma control and quality of life were modest, they suggest potential clinical significance, indicating that dietary changes could be beneficial for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma.Ma, J., Strub, P., Lv, N., et al.[2018]