Nutrition for Asthmatics (INHALE)

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Asthma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06151405

1K01HL169491-01 (U.S. NIH Grant/Contract)

PBRC 2022-001 B

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 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