Nutrition for Asthmatics

Study Overview
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Brief Summary
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Determine to what extent three distinct dietary approaches improve asthma control and lung function.

Detailed Description
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This is a crossover design pilot trial that will recruit 15 adults with asthma. Participants will undergo screening and a lead-in period before being randomized to a series of three, 7-day diets with a 7+ day washout period between each diet. Asthma control and lung function will be assessed at the completion of each diet. The goal of this pilot trial is to understand the effect of diet on asthma and conduct an exploratory analysis on factors that may predict the response to diet.

Official Title
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Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)

Conditions
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Asthma

Intervention / Treatment
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* Other: DGA Diet
* Other: MCT Diet
* Other: KETO Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Guidelines for Americans<br>7 days of a diet consistent with the Dietary Guidelines for Americans (DGA). | Other: DGA Diet<br>* 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.<br>|
| Experimental: Medium Chain Triglyceride Supplemented DGA<br>7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT). | Other: MCT Diet<br>* A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).<br>|
| Experimental: Ketogenic Diet<br>7 days of a ketogenic diet (KETO). | Other: KETO Diet<br>* A fully provisioned isocaloric, isonitrogenous ketogenic study diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | Baseline | 
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | After 7 days on Diet#1 | 
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | After 7 days on Diet#2 | 
| Asthma Control | Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5. | After 7 days on Diet#3 | 
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | Baseline | 
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | After 7 days on Diet#1 | 
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | After 7 days on Diet#2 | 
| Lung Function | FEV1 (forced expiratory volume in 1 second; % of predicted) | After 7 days on Diet#3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammation | plasma interleukin-6 (IL6) | Baseline | 
| Systemic inflammation | plasma interleukin-6 (IL6) | After 7 days on Diet#1 | 
| Systemic inflammation | plasma interleukin-6 (IL6) | After 7 days on Diet#2 | 
| Systemic inflammation | plasma interleukin-6 (IL6) | After 7 days on Diet#3 | 
| FENO | FENO (ppm) | Baseline | 
| FENO | FENO (ppm) | After 7 days on Diet#1 | 
| FENO | FENO (ppm) | After 7 days on Diet#2 | 
| FENO | FENO (ppm) | After 7 days on Diet#3 | 
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | Baseline | 
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | After 7 days on Diet#1 | 
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | After 7 days on Diet#2 | 
| FEV1/FVC | FEV1/Forced Vital Capacity (FVC) ratio | After 7 days on Diet#3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketone, diet, metabolism