Specialized Diets for Asthma

(INHALE Trial)

Overseen By John P Kirwan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Diabetes medications

Disqualifiers: Diabetes, COPD, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different diets can help manage asthma and improve lung function. Participants will follow one of three diets: a standard healthy diet (DGA Diet), a healthy diet with added medium chain triglycerides (MCT Diet), or a ketogenic diet (KETO Diet, low-carb, high-fat). Adults diagnosed with partly controlled or uncontrolled asthma and who have stable medication use might be suitable candidates. This trial could be appropriate for those whose asthma affects daily life and who are open to trying a new diet for a week. As an unphased trial, it offers a unique opportunity to explore innovative dietary approaches to asthma management.

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 requires that your asthma medication has been stable for at least 2 months before joining. This suggests you should continue your current asthma treatment without changes.

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

A previous study demonstrated potential benefits of the Dietary Guidelines for Americans (DGA) diet for people with asthma. The DASH diet, similar to the DGA diet, improved asthma symptoms in children and teens, suggesting the DGA diet might also be safe and beneficial for asthma.

Research has shown that adding medium-chain triglycerides (MCTs) to a diet is generally safe. MCTs provide quick energy and are recommended as a safe dietary treatment for epilepsy, indicating their safety for other uses as well.

Studies have shown that the ketogenic (KETO) diet can reduce asthma symptoms by lowering airway inflammation. It is considered safe for long-term use, particularly for weight loss.

Overall, these diets have been studied and found safe for various health conditions. However, individual experiences may vary, and discussing dietary changes with a healthcare provider is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for asthma because they explore how specific diets might impact asthma management. Unlike traditional treatments like inhalers and medications that target symptoms, these diets, including the Dietary Guidelines for Americans (DGA) Diet, the Ketogenic (KETO) Diet, and a Medium Chain Triglyceride (MCT) supplemented diet, aim to modify inflammation and metabolic pathways that could influence asthma. The KETO Diet, known for its high-fat, low-carb approach, may alter energy metabolism in a way that affects airway inflammation. Meanwhile, the MCT supplemented DGA Diet introduces medium chain triglycerides, which could have unique anti-inflammatory effects. This dietary approach is unique because it could potentially offer a non-pharmacological way to manage asthma, which is an exciting prospect for both patients and researchers.

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

Research has shown that changing diet can help control asthma. In this trial, participants will follow different dietary approaches to evaluate their effects on asthma management. One group will adhere to the Dietary Guidelines for Americans, which recommend balanced eating and support evidence that diet affects health. Another group will follow a diet consistent with these guidelines but supplemented with medium-chain triglycerides (MCTs), which can lead to ketosis, a state that might help manage asthma by reducing inflammation. Additionally, a separate group will follow the ketogenic diet, high in fats and low in carbs, which studies suggest could decrease airway inflammation and lessen asthma symptoms. Each dietary approach offers a possible way to improve asthma control. ^{1 5 6 7 8}

Who Is on the Research Team?

Jacob T Mey, PhD, RD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a BMI of 18.5-29.99 who have asthma diagnosed by a specialist and partly controlled or uncontrolled symptoms, as shown by an Asthma Control Test score ≤22. Participants must have stable asthma medication use and own a device compatible with the ZEPHYRx platform.

Inclusion Criteria

My asthma has been diagnosed by a specialist.

Your body mass index (BMI) is between 18.5 and 29.99.

Owns a device compatible with ZEPHYRx platform

Exclusion Criteria

I do not have serious heart, lung, kidney, or liver conditions.

Pregnant or nursing women

Your blood pressure is very high and not well controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in

Participants undergo a lead-in period before starting the dietary interventions

1 week

Dietary Intervention

Participants follow three distinct 7-day dietary approaches with a washout period between each

21+ weeks

Visits at the end of each diet period

Follow-up

Participants are monitored for safety and effectiveness after the dietary interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DGA Diet
• KETO Diet
• MCT Diet

Trial Overview

The study aims to compare how three diets—MCT Diet, DGA Diet, and KETO Diet—affect asthma control and lung function in participants. It will determine which dietary approach may be most beneficial for improving health outcomes in asthmatics.

How Is the Trial Designed?

Group I: Medium Chain Triglyceride Supplemented DGA Experimental Treatment 1 Intervention

7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).

Group II: Ketogenic Diet Experimental Treatment 1 Intervention

7 days of a ketogenic diet (KETO).

Group III: Dietary Guidelines for Americans Experimental Treatment 1 Intervention

7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).

DGA Diet is already approved in United States for the following indications:

Approved in United States as Dietary Guidelines for Americans for:

• General health and wellness
• Chronic disease prevention
• Weight management

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The 2020-2025 Dietary Guidelines for Americans provide updated recommendations aimed at improving nutritional health and reducing the risk of chronic diseases among the population.

These guidelines emphasize the importance of a balanced diet, including a variety of fruits, vegetables, whole grains, and lean proteins, while also addressing the need to limit added sugars, saturated fats, and sodium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Guidelines for Americans (2020-2025): Pulses, Dietary Fiber, and Chronic Disease Risk-A Call for Clarity and Action. Thompson, HJ.[2021]

A systematic review of ten observational studies involving 153 to over 70,000 individuals found no strong evidence linking a Western diet pattern to the incidence or prevalence of asthma in adults.

While the studies did not show a clear connection between diet and the onset of asthma, there were some indications that a Western diet might be associated with increased asthma morbidity, suggesting that diet could still play a role in the severity of asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Western diet pattern and adult asthma: a focused review. Brigham, EP., Kolahdooz, F., Hansel, N., et al.[2022]

In a study of 1174 adults across five European countries, two dietary patterns were identified: one high in meats and potatoes, and another rich in fish, fruits, and vegetables, but neither showed a strong association with asthma or its symptoms.

The lack of consistent associations between these dietary patterns and asthma suggests that other factors may influence respiratory health, highlighting the complexity of dietary impacts on asthma across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and risk of asthma: results from three countries in European Community Respiratory Health Survey-II. Hooper, R., Heinrich, J., Omenaas, E., et al.[2021]

Updates to the Dietary Guidelines for Americans (DGAs) have led to more recent diet quality indices that show a stronger association with the risk of coronary artery disease, based on a study of 3267 participants from the Framingham Heart Study.

While adherence to any dietary index was linked to a lower risk of cardiovascular diseases overall, the improvements in diet indices did not show a significant impact on the risk of stroke or heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet Indices Reflecting Changes to Dietary Guidelines for Americans from 1990 to 2015 Are More Strongly Associated with Risk of Coronary Artery Disease Than the 1990 Diet Index. Rebholz, CM., Kim, H., Ma, J., et al.[2022]

An 8-week study involving 52 overweight and obese women found that following a Dietary Guidelines for Americans (DGA) diet led to a significant reduction in systolic blood pressure by approximately 9 mm Hg, indicating potential cardiovascular benefits.

However, neither the DGA diet nor the typical American diet (TAD) had an impact on fasting insulin, glucose levels, or lipid profiles, suggesting that simply changing dietary patterns may not affect these metabolic markers in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled-feeding trial based on the Dietary Guidelines for Americans on cardiometabolic health indexes. Krishnan, S., Adams, SH., Allen, LH., et al.[2023]

Adherence to the DASH diet and the 2015-2020 Dietary Guidelines for Americans is linked to a lower likelihood of obesity among Canadian adults, based on analysis of dietary recall data from over 23,000 participants across two survey cycles.

While the Mediterranean diet showed a similar trend, its association with obesity was not statistically significant in the more recent data, suggesting that DASH and DGA may be more effective dietary patterns for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a priori dietary patterns in relation to obesity: results from two cycles of the Canadian National Nutrition Survey. Ng, AP., Jessri, M., L'Abbé, MR.[2023]

In a study of 1486 Chinese adults, MSG intake was not found to be associated with asthma, suggesting that dietary MSG may not be a risk factor for the condition.

However, a 'traditional' dietary pattern, characterized by high consumption of rice, wheat flour, and vegetables, was positively associated with asthma, indicating that certain dietary habits may influence asthma prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monosodium glutamate intake, dietary patterns and asthma in Chinese adults. Shi, Z., Yuan, B., Wittert, GA., et al.[2021]

The study successfully modeled dairy-free and vegan adaptations of the Healthy Vegetarian Dietary Pattern (HVDP) using foods already recommended in the 2020 Dietary Guidelines for Americans, showing that minimal changes were needed to maintain nutritional adequacy.

Both the dairy-free and vegan models provided sufficient nutrients to meet Dietary Reference Intakes (DRIs) for most age and sex groups, although zinc was the only nutrient that fell below the DRI for males, indicating these adaptations can effectively support diverse dietary needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling Dairy-Free Vegetarian and Vegan USDA Food Patterns for Nonpregnant, Nonlactating Adults. Hess, JM.[2023]

Despite advancements in asthma diagnosis and treatment, mortality rates have been rising in developed countries over the past 10-15 years, potentially due to factors like pollution, delays in seeking care, and changes in asthma education.

The authors suggest that dietary changes, particularly increased consumption of polyunsaturated fats and refined foods, may contribute to worsening asthma management and inflammation in the airways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma mortality: another opinion--is it a matter of life and ... bread? Chang, CC., Phinney, SD., Halpern, GM., et al.[2019]

Diets rich in fruits, vegetables, antioxidants, omega-3 fatty acids, and soluble fiber, like the Mediterranean diet, may help reduce asthma risk and improve management, especially in young children, although the evidence is mixed.

Conversely, a Westernized diet high in saturated fats, refined grains, and sugars may contribute to inflammation, potentially leading to the development and worsening of asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition in Asthma. Williams, EJ., Berthon, BS., Stoodley, I., et al.[2022]

This systematic review aims to evaluate the relationship between dietary intake and asthma risk in both children and adults, following PRISMA guidelines and utilizing a comprehensive approach to analyze recent epidemiological studies.

The results of this review will contribute to evidence-based clinical practice guidelines on lifestyle interventions for managing asthma, potentially influencing dietary recommendations for asthma prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake and risk of asthma in children and adults: protocol for a systematic review and meta-analysis. Garcia-Larsen, V., Del Giacco, SR., Moreira, A., et al.[2020]

In a study of 34,766 participants, a healthier diet was linked to fewer asthma symptoms, with significant reductions in symptom scores for both men and women, particularly noted with the Alternate Healthy Eating Index 2010 (AHEI-2010).

Among the 2,609 participants with asthma, a healthier diet was associated with better asthma control, showing a strong effect in men and a borderline significant effect in women, suggesting dietary improvements could enhance asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between dietary scores with asthma symptoms and asthma control in adults. Andrianasolo, RM., Kesse-Guyot, E., Adjibade, M., et al.[2019]

In a study of 54,672 French females, no overall dietary patterns were linked to the incidence of asthma, but specific dietary habits were associated with asthma severity.

A 'Western' dietary pattern was linked to a higher risk of frequent asthma attacks, while a 'nuts and wine' dietary pattern was associated with a lower risk of such attacks, suggesting that diet may influence asthma exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and asthma in the E3N study. Varraso, R., Kauffmann, F., Leynaert, B., et al.[2022]

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2020-2025

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