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RecruitingNCT06151405INHALEUpdated Sep 19, 2024

Nutrition for Asthmatics

An interventional study of DGA Diet and MCT Diet in Asthma, sponsored by Pennington Biomedical Research Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • ketone
  • diet
  • metabolism
03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's planned enrollment of 15 is below the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.

Browse Pennington Biomedical Research Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Dietary Guidelines for Americans

    7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).

    Other: DGA Diet

  • 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

  • Experimental
    Ketogenic Diet

    7 days of a ketogenic diet (KETO).

    Other: KETO Diet

Interventions

  • OtherDGA 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.

  • OtherMCT Diet

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

  • OtherKETO Diet

    A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

06

What researchers measure

Primary outcomes

  1. Asthma Control

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

    Time frame: Baseline

  2. Asthma Control

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

    Time frame: After 7 days on Diet#1

  3. Asthma Control

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

    Time frame: After 7 days on Diet#2

  4. Asthma Control

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

    Time frame: After 7 days on Diet#3

  5. Lung Function

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

    Time frame: Baseline

  6. Lung Function

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

    Time frame: After 7 days on Diet#1

  7. Lung Function

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

    Time frame: After 7 days on Diet#2

  8. Lung Function

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

    Time frame: After 7 days on Diet#3

Secondary outcomes

  1. Systemic inflammation

    plasma interleukin-6 (IL6)

    Time frame: Baseline

  2. Systemic inflammation

    plasma interleukin-6 (IL6)

    Time frame: After 7 days on Diet#1

  3. Systemic inflammation

    plasma interleukin-6 (IL6)

    Time frame: After 7 days on Diet#2

  4. Systemic inflammation

    plasma interleukin-6 (IL6)

    Time frame: After 7 days on Diet#3

  5. FENO

    FENO (ppm)

    Time frame: Baseline

  6. FENO

    FENO (ppm)

    Time frame: After 7 days on Diet#1

  7. FENO

    FENO (ppm)

    Time frame: After 7 days on Diet#2

  8. FENO

    FENO (ppm)

    Time frame: After 7 days on Diet#3

  9. FEV1/FVC

    FEV1/Forced Vital Capacity (FVC) ratio

    Time frame: Baseline

  10. FEV1/FVC

    FEV1/Forced Vital Capacity (FVC) ratio

    Time frame: After 7 days on Diet#1

  11. FEV1/FVC

    FEV1/Forced Vital Capacity (FVC) ratio

    Time frame: After 7 days on Diet#2

  12. FEV1/FVC

    FEV1/Forced Vital Capacity (FVC) ratio

    Time frame: After 7 days on Diet#3

Other outcomes

  1. indirect calorimetry

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

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

  2. ketosis

    plasma ß-hydroxybutyrate (mM)

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

  3. eosinophilic asthma characterization

    absolute blood eosinophils (count)

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

  4. immunoglobulin asthma characterization

    blood immunoglobulin E (IgE)

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

  5. systemic inflammation

    blood cytokines (IL17, TNFα, IL1ß)

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

07

Study locations

1 of 1 sites recruiting
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
    • Executive Director · Contact · 225-763-2513
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

Of 466 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's planned 29 months is above that.

Counting every sponsor, half of 502 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2023
First posted
Nov 30, 2023
StartActual
Jul 17, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Mar 1, 2027
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06151405
Lead sponsor
Pennington Biomedical Research Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Jacob T. Mey, PhD RD (Principal Investigator, Pennington Biomedical Research Center) — Principal investigator
First posted
Nov 30, 2023
Start date
Jul 17, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Sep 19, 2024

Study contacts

Jacob T Mey, PhD, RD
Contact
jacob.mey@pbrc.edu
225-763-2644
John P Kirwan, PhD
Contact
john.kirwan@pbrc.edu
225-763-2644
Jacob T Mey, PhD, RD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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