AsthmaINHALENCT06151405
Nutrition for Asthmatics
A study testing DGA Diet, MCT Diet and KETO Diet in people with Asthma, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Determine to what extent three distinct dietary approaches improve asthma control and lung function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- DGA Diet, MCT Diet and KETO Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Executive Director, 225-763-2513
About this study
Official title: 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.
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.
- Conditions
- Asthma
- Being tested
- DGA Diet, MCT Diet, KETO Diet
- Keywords
- ketone, diet, metabolism
- Medical subject headings
- Asthma, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DGA DietOther
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 DietOther
A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
KETO DietOther
A fully provisioned isocaloric, isonitrogenous ketogenic study diet.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Guidelines for Americans | Experimental | 7 days of a diet consistent with the Dietary Guidelines for Americans (DGA). Receives: Other: DGA Diet |
| Medium Chain Triglyceride Supplemented DGA | Experimental | 7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT). Receives: Other: MCT Diet |
| Ketogenic Diet | Experimental | 7 days of a ketogenic diet (KETO). Receives: Other: KETO Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Measured: Baseline
Asthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Measured: 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.
Measured: 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.
Measured: After 7 days on Diet#3
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Measured: Baseline
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Measured: After 7 days on Diet#1
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Measured: After 7 days on Diet#2
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Measured: After 7 days on Diet#3
Secondary outcomes (12)
Systemic inflammation
plasma interleukin-6 (IL6)
Measured: Baseline
Systemic inflammation
plasma interleukin-6 (IL6)
Measured: After 7 days on Diet#1
Systemic inflammation
plasma interleukin-6 (IL6)
Measured: After 7 days on Diet#2
Systemic inflammation
plasma interleukin-6 (IL6)
Measured: After 7 days on Diet#3
FENO
FENO (ppm)
Measured: Baseline
FENO
FENO (ppm)
Measured: After 7 days on Diet#1
FENO
FENO (ppm)
Measured: After 7 days on Diet#2
FENO
FENO (ppm)
Measured: After 7 days on Diet#3
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Measured: Baseline
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Measured: After 7 days on Diet#1
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Measured: After 7 days on Diet#2
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
Measured: After 7 days on Diet#3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start17 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jacob T. Mey, PhD RD, Pennington Biomedical Research Center
- Investigators
- Jacob T Mey, PhD, RD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151405
- Sponsor's protocol ID
- PBRC 2022-001 B
- Other IDs
- 1K01HL169491-01
- Acronym
- INHALE
- Status last verified
- Sep 2024
- First submitted
- 21 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)
- ClinicalTrials.gov ID
- NCT06151405
- Acronym / sponsor ID
- INHALE / PBRC 2022-001 B
- Conditions
- Asthma
- Keywords
- ketone, diet, metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Guidelines for Americans | Experimental | Other: DGA Diet7 days of a diet consistent with the Dietary Guidelines for Americans (DGA). |
| Medium Chain Triglyceride Supplemented DGA | Experimental | Other: MCT Diet7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT). |
| Ketogenic Diet | Experimental | Other: KETO Diet7 days of a ketogenic diet (KETO). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DGA DietA 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. | Other | Dietary Guidelines for Americans |
| MCT DietA fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT). | Other | Medium Chain Triglyceride Supplemented DGA |
| KETO DietA fully provisioned isocaloric, isonitrogenous ketogenic study diet. | Other | Ketogenic Diet |
Primary outcome
Asthma Control
Time frame: Baseline
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
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.
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.
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.
Lung Function
Time frame: Baseline
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
Time frame: After 7 days on Diet#1
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
Time frame: After 7 days on Diet#2
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
Time frame: After 7 days on Diet#3
FEV1 (forced expiratory volume in 1 second; % of predicted)
12 secondary outcomes
Systemic inflammation
Time frame: Baseline
Systemic inflammation
Time frame: After 7 days on Diet#1
Systemic inflammation
Time frame: After 7 days on Diet#2
Systemic inflammation
Time frame: After 7 days on Diet#3
FENO
Time frame: Baseline
FENO
Time frame: After 7 days on Diet#1
FENO
Time frame: After 7 days on Diet#2
FENO
Time frame: After 7 days on Diet#3
FEV1/FVC
Time frame: Baseline
FEV1/FVC
Time frame: After 7 days on Diet#1
FEV1/FVC
Time frame: After 7 days on Diet#2
FEV1/FVC
Time frame: After 7 days on Diet#3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob T Mey, PhD, RD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DGA Diet, MCT Diet and KETO Diet in people with Asthma, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob T Mey, PhD, RD (225-763-2644, jacob.mey@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.