Nutrition for Asthmatics

Asthma Clinical Trial

— INHALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151405
• Other study ID #: PBRC 2022-001 B
• Secondary ID: 1K01HL169491-01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: June 2024
• Source: Pennington Biomedical Research Center
• Contact: Jacob T Mey, PhD, RD
• Phone: 225-763-2644
• Email: jacob.mey[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 1, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• MCT Diet
A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
• KETO Diet
A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	ketosis	plasma ß-hydroxybutyrate (mM)	baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
Other	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
Other	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
Other	systemic inflammation	blood cytokines (IL17, TNFa, IL1ß)	baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3
Primary	Asthma Control	Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.	Baseline
Primary	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
Primary	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
Primary	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
Primary	Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	Baseline
Primary	Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	After 7 days on Diet#1
Primary	Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	After 7 days on Diet#2
Primary	Lung Function	FEV1 (forced expiratory volume in 1 second; % of predicted)	After 7 days on Diet#3
Secondary	Systemic inflammation	plasma interleukin-6 (IL6)	Baseline
Secondary	Systemic inflammation	plasma interleukin-6 (IL6)	After 7 days on Diet#1
Secondary	Systemic inflammation	plasma interleukin-6 (IL6)	After 7 days on Diet#2
Secondary	Systemic inflammation	plasma interleukin-6 (IL6)	After 7 days on Diet#3
Secondary	FENO	FENO (ppm)	Baseline
Secondary	FENO	FENO (ppm)	After 7 days on Diet#1
Secondary	FENO	FENO (ppm)	After 7 days on Diet#2
Secondary	FENO	FENO (ppm)	After 7 days on Diet#3
Secondary	FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	Baseline
Secondary	FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	After 7 days on Diet#1
Secondary	FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	After 7 days on Diet#2
Secondary	FEV1/FVC	FEV1/Forced Vital Capacity (FVC) ratio	After 7 days on Diet#3