NCT06151405 · Pennington Biomedical Research Center
Nutrition for Asthmatics
(INHALE)
What this study is about
Determine to what extent three distinct dietary approaches improve asthma control and lung function.
View original scientific description
Determine to what extent three distinct dietary approaches improve asthma control and lung function.
Interventions
OTHER
DGA Diet
A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: * A variety of vegetables and fruits * Grains, at least half of which are whole grains * Fat-free or low-fat dairy * A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds * This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
OTHER
MCT Diet
A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
OTHER
KETO Diet
A fully provisioned isocaloric, isonitrogenous ketogenic study diet.
Primary outcome measures
Asthma Control
Time frame: Baseline
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control
Time frame: After 7 days on Diet#1
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control
Time frame: After 7 days on Diet#2
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control
Time frame: After 7 days on Diet#3
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Lung Function
Time frame: Baseline
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
Time frame: After 7 days on Diet#1
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
Time frame: After 7 days on Diet#2
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
Time frame: After 7 days on Diet#3
FEV1 (forced expiratory volume in 1 second; % of predicted)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age: 18-65 years
- BMI: 18.5 - 29.99 kg/m2
- asthma diagnosed by medical specialist (confirmed in medical history)
- partly controlled or uncontrolled asthma by Asthma Control Test score ≤22
- owns a device compatible with ZEPHYRx platform
- stable asthma medication use (no change in the past 2 months).
Exclusion criteria
- Diabetes or using diabetes medications that may lower blood glucose levels
- point of care fasting blood glucose ≥126 mg/dl or triglycerides ≥400 mg/dl
- current smoking or smoking history of greater than 10 pack-years
- other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease; uncontrolled hypertension defined as systolic blood pressure ≥160 mm/Hg, or diastolic blood pressure ≥100 mm/Hg
- pregnant or nursing women
- food preferences or allergies inconsistent with study diet capabilities
- noncompliance with lead-in period requirements.
Where
- Baton Rouge, Louisiana
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2024 · Source of record for eligibility and locations