Determine to what extent three distinct dietary approaches improve asthma control and lung function.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
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.
A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
A fully provisioned isocaloric, isonitrogenous ketogenic study diet.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
RECRUITINGAsthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Time frame: Baseline
Asthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Time frame: 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.
Time frame: 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.
Time frame: After 7 days on Diet#3
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: Baseline
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: After 7 days on Diet#1
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: After 7 days on Diet#2
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: After 7 days on Diet#3
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Systemic inflammation
plasma interleukin-6 (IL6)
Time frame: Baseline
Systemic inflammation
plasma interleukin-6 (IL6)
Time frame: After 7 days on Diet#1
Systemic inflammation
plasma interleukin-6 (IL6)
Time frame: After 7 days on Diet#2
Systemic inflammation
plasma interleukin-6 (IL6)
Time frame: After 7 days on Diet#3
FENO
FENO (ppm)
Time frame: Baseline
FENO
FENO (ppm)
Time frame: After 7 days on Diet#1
FENO
FENO (ppm)
Time frame: After 7 days on Diet#2
FENO
FENO (ppm)
Time frame: After 7 days on Diet#3
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: Baseline
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: After 7 days on Diet#1
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: After 7 days on Diet#2
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: After 7 days on Diet#3