Nutrition for Asthmatics with Obesity

Not Applicable

Completed

• Conditions: Asthma; Obesity

• Registration Number: NCT05222451
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

This study will test the effect of diet on asthma in individuals with obesity.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-03
• Study Start: 2022-06-27
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age: 18-65 years
• BMI: 30-45 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Asthma Control	After 7 days on Diet#3	Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.

Secondary Outcome Measures

Name	Time	Method
FENO	After 7 days on Diet#3	FENO (ppm)
FEV1/FVC	After 7 days on Diet#3	FEV1/Forced Vital Capacity (FVC) ratio
Lung Function	After 7 days on Diet#3	FEV1 (forced expiratory volume in 1 second; % of predicted)

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States