AsthmaNCT05222451
Nutrition for Asthmatics with Obesity
A study testing DGA Diet, MCT Diet and KETO Diet in people with Asthma and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study will test the effect of diet on asthma in individuals with obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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: 30-45 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.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Nutritional Strategies to Enhance Lung Function in Asthmatics with Obesity
This study will test the effect of diet on asthma in individuals with obesity.
Read the detailed description
This is a crossover design pilot trial that will recruit 12 adults with obesity and 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.
- Being tested
- DGA Diet, MCT Diet, KETO Diet
- Keywords
- ketone, diet, metabolism
- Medical subject headings
- Asthma, Obesity, 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
Secondary outcomes (12)
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
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 posted3 Feb 2022
- Study start27 Jun 2022
- Primary completion18 Dec 2024
- Study completion31 Dec 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- 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
- NCT05222451
- Sponsor's protocol ID
- PBRC 2022-001 A
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2022
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will be provided upon request and approval by study PI.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Strategies to Enhance Lung Function in Asthmatics with Obesity
- ClinicalTrials.gov ID
- NCT05222451
- Acronym / sponsor ID
- PBRC 2022-001 A
- Keywords
- ketone, diet, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Feb 2022 (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.
This study will test the effect of diet on asthma in individuals with obesity.
Detailed description
This is a crossover design pilot trial that will recruit 12 adults with obesity and 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, 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: 30-45 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.
12 secondary outcomes
Lung Function
Time frame: Baseline
Lung Function
Time frame: After 7 days on Diet#1
Lung Function
Time frame: After 7 days on Diet#2
Lung Function
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No. Study data will be provided upon request and approval by study PI.
Related trials for Asthma
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
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. This study is not recruiting at the moment.
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 and Obesity, 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: finished, as of the sponsor's last update on 4 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control (time frame: Baseline). The study lists 4 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 4 Feb 2025.