Clinical trial NCT06151405: Nutrition for Asthmatics
Official title: Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: ketone
diet
metabolism
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-11-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Determine to what extent three distinct dietary approaches improve asthma control and lung function.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma Control
timeFrame: Baseline
measure: Asthma Control
timeFrame: After 7 days on Diet#1
measure: Asthma Control
timeFrame: After 7 days on Diet#2
measure: Asthma Control
timeFrame: After 7 days on Diet#3
measure: Lung Function
timeFrame: Baseline
measure: Lung Function
timeFrame: After 7 days on Diet#1
measure: Lung Function
timeFrame: After 7 days on Diet#2
measure: Lung Function
timeFrame: After 7 days on Diet#3
Secondary outcomes:
measure: Systemic inflammation
timeFrame: Baseline
measure: Systemic inflammation
timeFrame: After 7 days on Diet#1
measure: Systemic inflammation
timeFrame: After 7 days on Diet#2
measure: Systemic inflammation
timeFrame: After 7 days on Diet#3
measure: FENO
timeFrame: Baseline
measure: FENO
timeFrame: After 7 days on Diet#1
measure: FENO
timeFrame: After 7 days on Diet#2
measure: FENO
timeFrame: After 7 days on Diet#3
measure: FEV1/FVC
timeFrame: Baseline
measure: FEV1/FVC
timeFrame: After 7 days on Diet#1
measure: FEV1/FVC
timeFrame: After 7 days on Diet#2
measure: FEV1/FVC
timeFrame: After 7 days on Diet#3
Other outcomes:
measure: indirect calorimetry
timeFrame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
measure: ketosis
timeFrame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
measure: eosinophilic asthma characterization
timeFrame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
measure: immunoglobulin asthma characterization
timeFrame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
measure: systemic inflammation
timeFrame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Jacob T Mey, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: