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NCT Number: NCT06151405

Nutrition for Asthmatics

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location status: Recruiting

Location contact

Executive Director

CONTACT

225-763-2513

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DGA Diet

Other

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

Other

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

KETO Diet

Other

A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Primary outcomes

  1. Asthma Control

    Time frame: Baseline

    Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.

  2. Asthma Control

    Time frame: After 7 days on Diet#1

    Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.

  3. Asthma Control

    Time frame: After 7 days on Diet#2

    Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.

  4. Asthma Control

    Time frame: After 7 days on Diet#3

    Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.

  5. Lung Function

    Time frame: Baseline

    FEV1 (forced expiratory volume in 1 second; % of predicted)

  6. Lung Function

    Time frame: After 7 days on Diet#1

    FEV1 (forced expiratory volume in 1 second; % of predicted)

  7. Lung Function

    Time frame: After 7 days on Diet#2

    FEV1 (forced expiratory volume in 1 second; % of predicted)

  8. Lung Function

    Time frame: After 7 days on Diet#3

    FEV1 (forced expiratory volume in 1 second; % of predicted)

Secondary outcomes

  1. Systemic inflammation

    Time frame: Baseline

    plasma interleukin-6 (IL6)

  2. Systemic inflammation

    Time frame: After 7 days on Diet#1

    plasma interleukin-6 (IL6)

  3. Systemic inflammation

    Time frame: After 7 days on Diet#2

    plasma interleukin-6 (IL6)

  4. Systemic inflammation

    Time frame: After 7 days on Diet#3

    plasma interleukin-6 (IL6)

  5. FENO

    Time frame: Baseline

    FENO (ppm)

  6. FENO

    Time frame: After 7 days on Diet#1

    FENO (ppm)

  7. FENO

    Time frame: After 7 days on Diet#2

    FENO (ppm)

  8. FENO

    Time frame: After 7 days on Diet#3

    FENO (ppm)

  9. FEV1/FVC

    Time frame: Baseline

    FEV1/Forced Vital Capacity (FVC) ratio

  10. FEV1/FVC

    Time frame: After 7 days on Diet#1

    FEV1/Forced Vital Capacity (FVC) ratio

  11. FEV1/FVC

    Time frame: After 7 days on Diet#2

    FEV1/Forced Vital Capacity (FVC) ratio

  12. FEV1/FVC

    Time frame: After 7 days on Diet#3

    FEV1/Forced Vital Capacity (FVC) ratio

Other outcomes

  1. indirect calorimetry

    Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

    nutrient utilization according to respiratory exchange ratio (0.66 - 1.0)

  2. ketosis

    Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

    plasma ß-hydroxybutyrate (mM)

  3. eosinophilic asthma characterization

    Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

    absolute blood eosinophils (count)

  4. immunoglobulin asthma characterization

    Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

    blood immunoglobulin E (IgE)

  5. systemic inflammation

    Time frame: baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

    blood cytokines (IL17, TNFα, IL1ß)

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob T Mey, PhD, RD

CONTACT

[email protected]

225-763-2644

John P Kirwan, PhD

CONTACT

[email protected]

225-763-2644

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: INHALE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 30, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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