Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT05222451
This study will test the effect of diet on asthma in individuals with obesity.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
This is a crossover design pilot trial that will recruit 12 adults with obesity and 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
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
Pennington Biomedical Research Center
Other
Nutritional Strategies to Enhance Lung Function in Asthmatics with Obesity
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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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