Nutrition for Asthmatics

Not Applicable

Recruiting

• Conditions: Asthma
• Interventions: Other: KETO Diet; Other: DGA Diet; Other: MCT Diet

• Registration Number: NCT06151405
• Lead Sponsor: Pennington Biomedical Research Center

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.

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Study Start: 2024-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketogenic Diet	KETO Diet	7 days of a ketogenic diet (KETO).
Dietary Guidelines for Americans	DGA Diet	7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).
Medium Chain Triglyceride Supplemented DGA	MCT Diet	7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).

Primary Outcome Measures

Name	Time	Method
Lung Function	After 7 days on Diet#3	FEV1 (forced expiratory volume in 1 second; % of predicted)
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
Systemic inflammation	After 7 days on Diet#3	plasma interleukin-6 (IL6)

Trial Locations

Locations (1)

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