Status:

COMPLETED

Nutrition for Asthmatics with Obesity

Lead Sponsor:

Pennington Biomedical Research Center

Collaborating Sponsors:

The Cleveland Clinic

Conditions:

Asthma

Obesity

Eligibility:

All Genders

18-65 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 27 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT05222451

Start Date

June 27 2022

End Date

December 31 2024

Last Update

February 4 2025

Active Locations (1)

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808