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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage asthma through nutrition. Researchers are testing various diets, such as a low-calorie shake and medium chain triglycerides (a type of fat), to determine their effectiveness in reducing asthma symptoms. Another aspect of the trial involves controlled exposure to allergens (Whole Lung Allergen Challenge) to gain a deeper understanding of asthma. Individuals diagnosed with asthma who experience frequent attacks may be suitable candidates for this study. As an Early Phase 1 trial, this research aims to understand how these nutritional approaches work in people, offering participants an opportunity to contribute to groundbreaking asthma management strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, participants using a Nutritional Approach for Asthma with medium chain triglycerides (MCTs) did not report any serious side effects. MCTs are generally considered safe and have been used in many dietary studies without notable problems.

Research on the Alternate Day Diet has shown promising results. Most participants completed the program without major side effects. Fewer than 15% reported mild digestive issues, such as constipation or diarrhea.

Studies have shown that the Whole Lung Allergen Challenge is a safe way to study asthma. This method is well-tolerated, even with repeated allergen exposure, and serious side effects are rare.

Overall, these approaches have been tested with minimal safety concerns. Participants experienced few issues, and those that did occur were mild. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Nutritional Therapy for Asthma trial because it explores alternative ways to manage asthma through dietary changes. Unlike standard asthma treatments that typically involve inhalers or medications to open airways, this trial focuses on using medium chain triglycerides (MCTs) and low-caloric shakes to potentially influence asthma symptoms. MCTs are unique because they are a type of fat that the body can quickly convert into energy, which might help reduce inflammation. Additionally, the Whole Lung Allergen Challenge provides insights into how controlled exposure to allergens can affect lung responses, potentially leading to new ways to assess and manage asthma triggers. This trial could pave the way for more holistic asthma management approaches that complement existing treatments.

What evidence suggests that this trial's treatments could be effective for asthma?

Research suggests that changing diet might help manage asthma. In this trial, participants will join different treatment arms to explore these dietary approaches. One arm will focus on medium chain triglycerides (MCTs), a type of fat. Studies have found that MCTs might help control asthma by influencing blood fat types.

Another arm will investigate alternate day calorie restriction, which has shown promise in improving asthma symptoms, lung function, and reducing inflammation within two weeks.

Additionally, the trial includes a whole lung allergen challenge to examine how allergens affect asthma, primarily for research purposes rather than treatment. Each of these methods remains under study, and early results are helping researchers understand how diet might play a role in managing asthma. ^{1 3 6 7 8}

Who Is on the Research Team?

Serpil Erzurum, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Nutritional Approach for Asthma Active Control 1 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 Challenge Active Control 1 Intervention

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

Group III: Alternate Day Diet Active Control 1 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 Diet Placebo Group 1 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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1859864/

Alternate Day Calorie Restriction Improves Clinical ... Their asthma related symptoms, control and QOL improved significantly, and PEF increased significantly, within 2 weeks of diet initiation; these changes ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17291990/

Alternate day calorie restriction improves clinical findings and ... Alternate day calorie restriction improves clinical findings and reduces markers of oxidative stress and inflammation in overweight adults with moderate asthma.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306987706000892

The effect on health of alternate day calorie restriction Restricting caloric intake to 60–70% of normal adult weight maintenance requirement prolongs lifespan 30–50% and confers near perfect health across a broad ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219823014046

Weight Loss Interventions for Adults With Obesity-Related ... Weight loss can reduce the impact of obesity on asthma and improve patient outcomes by diverse mechanisms including modulating airway inflammation.

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)26603-4/fulltext

Short-term modified alternate-day fasting: a novel dietary ... Alternate day calorie restriction improves clinical findings and reduces markers of oxidative stress and inflammation in overweight adults with moderate asthma.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5042570/

A randomized pilot study comparing zero-calorie alternate ... No adverse effects were attributed to ADF and 93% completed the 8-week ADF protocol. At 8 weeks, ADF achieved a 376 kcal/day greater energy deficit, however ...

7. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-015-0029-9

Safety of alternate day fasting and effect on disordered eating ... [10] observed minimal adverse outcomes with 30-50% restriction after 4–12 weeks (<15% of participants reported constipation, diarrhea, or ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221321982100074X

A Practical Approach to Assist Asthmatics to Lose Weight A 24-week randomized controlled trial showed that exercise intervention improved asthma control by 23% measured by Asthma Control Test (ACT) scores and reduced ...