Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Location status: Recruiting
NCT Number: NCT06151405
Determine to what extent three distinct dietary approaches improve asthma control and lung function.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA)
Including:
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.
Time frame: Baseline
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 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 Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
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.
Time frame: Baseline
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: After 7 days on Diet#1
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: After 7 days on Diet#2
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: After 7 days on Diet#3
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time frame: Baseline
plasma interleukin-6 (IL6)
Time frame: After 7 days on Diet#1
plasma interleukin-6 (IL6)
Time frame: After 7 days on Diet#2
plasma interleukin-6 (IL6)
Time frame: After 7 days on Diet#3
plasma interleukin-6 (IL6)
Time frame: Baseline
FENO (ppm)
Time frame: After 7 days on Diet#1
FENO (ppm)
Time frame: After 7 days on Diet#2
FENO (ppm)
Time frame: After 7 days on Diet#3
FENO (ppm)
Time frame: Baseline
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: After 7 days on Diet#1
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: After 7 days on Diet#2
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: After 7 days on Diet#3
FEV1/Forced Vital Capacity (FVC) ratio
Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
nutrient utilization according to respiratory exchange ratio (0.66 - 1.0)
Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
plasma ß-hydroxybutyrate (mM)
Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
absolute blood eosinophils (count)
Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
blood immunoglobulin E (IgE)
Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
blood cytokines (IL17, TNFα, IL1ß)
Contact information is provided by the study sponsor or research team.
Jacob T Mey, PhD, RD
CONTACT
John P Kirwan, PhD
CONTACT
Pennington Biomedical Research Center
Other
Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)
Acronym: INHALE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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