Nutrition for Asthmatics with Obesity

Pennington Biomedical Research Center

Status: Completed

Conditions: Asthma; Obesity

Treatments: Other: DGA Diet; Other: KETO Diet; Other: MCT Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05222451

PBRC 2022-001 A

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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10 participants in 3 patient groups

Dietary Guidelines for Americans

Experimental group

Description:

7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).

Treatment:

Other: DGA Diet

Medium Chain Triglyceride Supplemented DGA

Experimental group

Description:

7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).

Treatment:

Other: MCT Diet

Ketogenic Diet

Experimental group

Description:

7 days of a ketogenic diet (KETO).

Treatment:

Other: KETO Diet