Specialized Diets for Asthma in Obesity
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 in people with obesity. Participants will follow one of three diets: a ketogenic diet (KETO Diet), a diet based on the Dietary Guidelines for Americans (DGA Diet), or the same diet with added medium-chain triglycerides (MCT Diet). The goal is to discover if these diets can improve asthma symptoms. The trial seeks individuals with a BMI between 30 and 45, who have been diagnosed with poorly controlled asthma and are using stable asthma medications. As an unphased trial, this study offers a unique opportunity to explore how dietary changes might enhance asthma management.
Do I need to stop my current medications for the trial?
The trial requires that your asthma medication has been stable for at least 2 months, so you should not change your current asthma medications to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the diets in this trial—the DGA Diet, KETO Diet, and MCT Diet—have different safety levels.
The DGA Diet follows the Dietary Guidelines for Americans, which are well-known and based on scientific evidence. These guidelines aim to support health at all ages, making them generally safe and easy to follow.
The ketogenic (KETO) diet is high in fat and low in carbs, prompting the body to burn fat for energy. Studies indicate it can be safe with supervision, but it might cause side effects like nutrient shortages if not managed well. However, it can benefit certain health issues, such as heart and metabolic health.
Medium-chain triglycerides (MCTs) are fats that the body can quickly use for energy. Research suggests MCTs can boost metabolism and brain function. They are usually safe, but high amounts might lead to fat buildup in the liver.
Each of these diets has been studied separately and appears safe for most people when followed correctly. However, individual reactions can differ, so healthcare providers should monitor progress.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these dietary approaches for managing asthma in individuals with obesity because they offer potentially impactful alternatives to standard medication-based therapies. The Ketogenic Diet (KETO) is unique for its low-carbohydrate, high-fat composition, which may help reduce inflammation and improve respiratory function rapidly. The Dietary Guidelines for Americans (DGA) diet emphasizes balanced nutrition, which supports overall health and may benefit asthma control. Meanwhile, the Medium Chain Triglyceride (MCT) supplemented DGA diet combines balanced nutrition with specific fats that may enhance metabolism and energy utilization, offering a novel way to support lung health. These diets are particularly promising because they could provide quick improvements in asthma symptoms, potentially within just a week.
What evidence suggests that this trial's diets could be effective for asthma in obesity?
Research shows that the ketogenic (KETO) diet, one of the treatment arms in this trial, can aid in weight loss and alter energy usage in the body. This diet, very low in carbs and high in fats, encourages the body to burn fat for energy instead of sugar. Studies have found that this can lead to weight loss and lower insulin levels.
Another treatment arm in this trial is the Dietary Guidelines for Americans (DGA) diet. Evidence suggests it supports heart health by including plenty of fruits, vegetables, and whole grains. This healthy eating pattern is linked to a lower risk of heart disease and improved overall health.
The Medium Chain Triglyceride (MCT) diet, also under study in this trial, may assist with weight loss by boosting energy use and promoting ketosis, a state where the body burns fat for fuel. Early research suggests that MCTs can help reduce body weight and fat mass.13678Who 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 obesity (BMI: 30-45 kg/m2) and partly controlled or uncontrolled asthma. Participants must have a stable asthma medication routine, no significant changes in the past two months, and be able to use the ZEPHYRx platform. Smokers, those with certain medical conditions like COPD or uncontrolled hypertension, pregnant/nursing women, diabetics on glucose-lowering meds, or individuals with food preferences/allergies that conflict with study diets cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lead-in
Participants undergo a lead-in period before randomization
Treatment
Participants are randomized to a series of three, 7-day diets with a 7+ day washout period between each diet
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DGA Diet
- KETO Diet
- MCT Diet
DGA Diet is already approved in United States for the following indications:
- General health and wellness
- Chronic disease prevention
- Weight management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pennington Biomedical Research Center
Lead Sponsor
The Cleveland Clinic
Collaborator