Nutrition for Asthmatics (INHALE)

Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: DGA Diet; Other: MCT Diet; Other: KETO Diet

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob T Mey, PhD, RD; Phone Number: 225-763-2644; Email: jacob.mey@pbrc.edu
• Study Contact Backup: Name: John P Kirwan, PhD; Phone Number: 225-763-2644; Email: john.kirwan@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
      • Contact: Executive Director; Phone Number: 225-763-2513

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Guidelines for Americans; 7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).	Other: DGA Diet; A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: A variety of vegetables and fruits; Grains, at least half of which are whole grains; Fat-free or low-fat dairy; A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds; This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
Experimental: Medium Chain Triglyceride Supplemented DGA; 7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).	Other: MCT Diet; A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
Experimental: Ketogenic Diet; 7 days of a ketogenic diet (KETO).	Other: KETO Diet; A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control	Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.	Baseline
Asthma Control	Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.	After 7 days on Diet#1
Asthma Control	Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.	After 7 days on Diet#2
Asthma Control	Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.	After 7 days on Diet#3
Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	Baseline
Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	After 7 days on Diet#1
Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	After 7 days on Diet#2
Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	After 7 days on Diet#3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FENO	FENO (ppm)	Baseline
FENO	FENO (ppm)	After 7 days on Diet#1
FENO	FENO (ppm)	After 7 days on Diet#2
FENO	FENO (ppm)	After 7 days on Diet#3
FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	Baseline
FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	After 7 days on Diet#1
FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	After 7 days on Diet#2
FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	After 7 days on Diet#3
Systemic inflammation	plasma interleukin-6 (IL6)	Baseline
Systemic inflammation	plasma interleukin-6 (IL6)	After 7 days on Diet#1
Systemic inflammation	plasma interleukin-6 (IL6)	After 7 days on Diet#2
Systemic inflammation	plasma interleukin-6 (IL6)	After 7 days on Diet#3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
indirect calorimetry	nutrient utilization according to respiratory exchange ratio (0.66 - 1.0)	baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
ketosis	plasma ß-hydroxybutyrate (mM)	baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
eosinophilic asthma characterization	absolute blood eosinophils (count)	baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
immunoglobulin asthma characterization	blood immunoglobulin E (IgE)	baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
systemic inflammation	blood cytokines (IL17, TNFα, IL1ß)	baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jacob T Mey, PhD, RD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: diet; metabolism; ketone
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: PBRC 2022-001 B; 1K01HL169491-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD is stored according to our institutional policy. External investigators may request additional data access, which will be shared according to institutional policy with appropriate data sharing agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No