AsthmaVEGASTHMANCT07480369
Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults
A study testing Omnivorous diet and Vegan diet in people with Asthma and Dietary Intervention, run by Medical University of Gdansk.
Trial summary
This randomized controlled study evaluates the effects of a balanced vegan diet compared with a balanced omnivorous diet on inflammatory and immune response markers and clinical asthma parameters in healthy adults and individuals with mild to moderate asthma, aged 18 to 50. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Dietary Intervention, Vegan Diet
- What is being tested?
- Omnivorous diet and Vegan diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to 30 Sep 2029
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For all groups:
- Aged 18-30 years
- Willing to adhere to assigned dietary plan (vegan or omnivorous) for 12 weeks
- Non-smoker for at least 5 years
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
- For the asthma group:
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- Clinical diagnosis of mild or moderate asthma (GINA criteria), made at least 12 months before enrollment
- Stable asthma status (no exacerbations or changes in therapy within the past 3 months)
- No change in pharmacotherapy during the study period
Who cannot join
- Use of systemic corticosteroids (oral or intravenous) within the past 3 months
- Ongoing biological therapy for asthma (e.g., anti-IgE, anti-IL-5, anti-IL-4R)
- Severe asthma as per GINA criteria
- Recent asthma exacerbation requiring hospitalization or steroid burst (<3 months)
- Presence of other chronic autoimmune or inflammatory diseases
- Pregnancy or lactation
Show all 10Show fewer
- Active infection or acute illness at the time of recruitment
- Adherence to specialized exclusion diets (e.g., ketogenic, low-FODMAP)
- History of eating disorders
- Inability or unwillingness to participate in follow-up visits or comply with the protocol
About this study
Official title: The Effect of a Vegan Diet on Inflammatory and Immune Biomarkers in Adult Patients With Asthma and in Healthy Individuals: A Randomized Controlled Trial
This randomized controlled study evaluates the effects of a balanced vegan diet compared with a balanced omnivorous diet on inflammatory and immune response markers and clinical asthma parameters in healthy adults and individuals with mild to moderate asthma, aged 18 to 50. Participants will follow assigned dietary plans for 12 weeks with dietitian support delivered via digital tools.
Read the detailed description
This prospective, randomized, controlled study aims to evaluate the effects of a balanced vegan diet on inflammatory and immune response markers, clinical asthma parameters, and metabolic profile in healthy adults and patients with mild to moderate asthma. The study will enroll participants aged 18 to 50 years, who will be randomly assigned to either a vegan diet intervention group or a control group following an omnivorous diet for 12 weeks.
Dietary interventions will be individually tailored by a clinical dietitian according to current national nutrition guidelines. To ensure safety and standardization, all participants will receive vitamin D supplementation (2000 IU/day), and participants in the vegan group will additionally receive vitamin B₁₂ supplementation (25-100 µg/day or weekly equivalent). Adherence to the diet will be monitored through weekly online consultations, 3-day food diaries, and digital tools.
Assessments will be performed at baseline and after 12 weeks of intervention. Evaluated parameters will include:
- Inflammatory markers: hsCRP, IL-4, IL-5, IL-13, TNF-α
- Immune function markers: lymphocyte subpopulations (CD4+, CD8+, CD4+/CD8+ ratio, Treg cells by flow cytometry/ELISA) and immunoglobulins (IgE, IgA, IgG, IgG1-IgG4)
- Respiratory function: fractional exhaled nitric oxide (FeNO), spirometry
- Anthropometric and body composition measures: body weight, body mass index (BMI), waist circumference, waist-to-hip ratio, bioimpedance body composition analysis
- Lipid profile: total cholesterol, HDL, LDL, non-HDL cholesterol, triglycerides
- Asthma symptom control: Asthma Control Test (ACT) scores The planned sample size is 280 participants, distributed across four groups (n=70 per group): healthy - omnivorous diet, healthy - vegan diet, asthma - omnivorous diet, asthma - vegan diet. However, an initial pilot phase will be conducted to assess feasibility and refine study procedures before full-scale recruitment.
- Conditions
- Asthma, Dietary Intervention, Vegan Diet
- Being tested
- Omnivorous diet, Vegan diet
- Keywords
- asthma, asthma control, inflammation, inflammatory markers, immune response, vegan diet, plant-based diet, randomized control trial, dietary intervention
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnivorous dietBehavioural
Participants will follow an individually planned, nutritionally adequate, isocaloric omnivorous diet for 12 weeks. Diet plans will be prepared by a clinical dietitian. Adherence will be monitored 3-day food diaries, weekly remote consultations, and digital tools. Participants will receive vitamin D supplementation (2000 IU/day).
Vegan dietBehavioural
Participants will follow an individually planned, nutritionally adequate isocaloric vegan diet for 12 weeks. Diet plans will be prepared by a clinical dietitian. Adherence will be monitored 3-day food diaries, weekly remote consultations, and digital tools. Participants will receive vitamin D supplementation (2000 IU/day) and vitamin B12 supplementation according to standard recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Omnivorous diet, healthy individuals | Active comparator | Not described Receives: Behavioral: Omnivorous diet |
| Vegan diet, healthy individuals | Experimental | Not described Receives: Behavioral: Vegan diet |
| Omnivorous diet, asthmatic individuals | Active comparator | Not described Receives: Behavioral: Omnivorous diet |
| Vegan diet, asthmatic individuals | Experimental | Not described Receives: Behavioral: Vegan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hsCRP levels
Change in serum high-sensitivity C-reactive protein (hsCRP) concentration as a marker of systemic inflammation.
Measured: Baseline and after week 12
Change in IL-4 levels
Change in serum interleukin-4 (IL-4) levels as an indicator of Th2-mediated inflammatory response.
Measured: Baseline and after week 12
Change in IL-5 levels
Change in serum interleukin-5 (IL-5) levels as a marker of eosinophilic inflammation.
Measured: Baseline and after week 12
Change in IL-13 levels
Change in serum interleukin-13 (IL-13) levels associated with allergic airway inflammation.
Measured: Baseline and after week 12
Change in TNF-α levels
Change in tumor necrosis factor alpha (TNF-α) levels as a marker of systemic inflammatory activity.
Measured: Baseline and after week 12
Secondary outcomes (14)
Change in lymphocyte subpopulations
Changes in lymphocyte subpopulations including CD4+, CD8+, CD4+/CD8+ ratio, and Treg cells
Measured: Baseline and after week 12
Change in serum IgE levels
Change in immunoglobulin E concentration associated with allergic inflammation.
Measured: Baseline and after week 12
Change in serum IgA levels
Change in immunoglobulin A concentration reflecting mucosal immune function.
Measured: Baseline and after week 12
Change in serum IgG levels
Change in total immunoglobulin G concentration.
Measured: Baseline and after week 12
Change in IgG subclasses
Changes in IgG subclasses including IgG1, IgG2, IgG3 and IgG4.
Measured: Baseline and after week 12
Change in fractional exhaled nitric oxide (FeNO)
Measurement of airway inflammation assessed using fractional exhaled nitric oxide.
Measured: Baseline and after week 12
Change in spirometry parameters
Changes in pulmonary function parameters (FEV1, FVC, FEV1/FVC)
Measured: Baseline and after week 12
Change in Asthma Control Test (ACT) score
Change in asthma symptom control measured using the Asthma Control Test (ACT). The ACT is a validated 5-item questionnaire with scores ranging from 5 to 25, where higher scores indicate better asthma control.
Measured: Baseline and after week 12
Change in lipid profile
Changes in total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol, and triglycerides
Measured: Baseline and after week 12
Change in body weight
Change in body weight measured in kilograms during the intervention.
Measured: Baseline and after week 12
Change in body mass index (BMI)
Change in BMI calculated from weight and height (kg/m²).
Measured: Baseline and after week 12
Change in waist circumference
Change in waist circumference as a measure of central adiposity
Measured: Baseline and after week 12
Change in waist-to-hip ratio (WHR)
Change in waist-to-hip ratio as a measure of body fat distribution.
Measured: Baseline and after week 12
Change in body composition
Changes in fat mass and lean mass assessed by bioimpedance analysis
Measured: Baseline and after week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completion30 Sep 2029 (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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480369
- Sponsor's protocol ID
- KB/556-86/2026
- Acronym
- VEGASTHMA
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Vegan Diet on Inflammatory and Immune Biomarkers in Adult Patients With Asthma and in Healthy Individuals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07480369
- Acronym / sponsor ID
- VEGASTHMA / KB/556-86/2026
- Conditions
- Asthma, Dietary Intervention, Vegan Diet
- Keywords
- asthma, asthma control, inflammation, inflammatory markers, immune response, vegan diet, plant-based diet, randomized control trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 18 Mar 2026 (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 randomized controlled study evaluates the effects of a balanced vegan diet compared with a balanced omnivorous diet on inflammatory and immune response markers and clinical asthma parameters in healthy adults and individuals with mild to moderate asthma, aged 18 to 50. Participants will follow assigned dietary plans for 12 weeks with dietitian support delivered via digital tools.
Detailed description
This prospective, randomized, controlled study aims to evaluate the effects of a balanced vegan diet on inflammatory and immune response markers, clinical asthma parameters, and metabolic profile in healthy adults and patients with mild to moderate asthma. The study will enroll participants aged 18 to 50 years, who will be randomly assigned to either a vegan diet intervention group or a control group following an omnivorous diet for 12 weeks.
Dietary interventions will be individually tailored by a clinical dietitian according to current national nutrition guidelines. To ensure safety and standardization, all participants will receive vitamin D supplementation (2000 IU/day), and participants in the vegan group will additionally receive vitamin B₁₂ supplementation (25-100 µg/day or weekly equivalent). Adherence to the diet will be monitored through weekly online consultations, 3-day food diaries, and digital tools.
Assessments will be performed at baseline and after 12 weeks of intervention. Evaluated parameters will include:
- Inflammatory markers: hsCRP, IL-4, IL-5, IL-13, TNF-α
- Immune function markers: lymphocyte subpopulations (CD4+, CD8+, CD4+/CD8+ ratio, Treg cells by flow cytometry/ELISA) and immunoglobulins (IgE, IgA, IgG, IgG1-IgG4)
- Respiratory function: fractional exhaled nitric oxide (FeNO), spirometry
- Anthropometric and body composition measures: body weight, body mass index (BMI), waist circumference, waist-to-hip ratio, bioimpedance body composition analysis
- Lipid profile: total cholesterol, HDL, LDL, non-HDL cholesterol, triglycerides
- Asthma symptom control: Asthma Control Test (ACT) scores The planned sample size is 280 participants, distributed across four groups (n=70 per group): healthy - omnivorous diet, healthy - vegan diet, asthma - omnivorous diet, asthma - vegan diet. However, an initial pilot phase will be conducted to assess feasibility and refine study procedures before full-scale recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Omnivorous diet, healthy individuals | Active comparator | Behavioral: Omnivorous diet |
| Vegan diet, healthy individuals | Experimental | Behavioral: Vegan diet |
| Omnivorous diet, asthmatic individuals | Active comparator | Behavioral: Omnivorous diet |
| Vegan diet, asthmatic individuals | Experimental | Behavioral: Vegan diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged 18-30 years
- Willing to adhere to assigned dietary plan (vegan or omnivorous) for 12 weeks
- Non-smoker for at least 5 years
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
- Clinical diagnosis of mild or moderate asthma (GINA criteria), made at least 12 months before enrollment
Key exclusion criteria (10 listed)
- Use of systemic corticosteroids (oral or intravenous) within the past 3 months
- Ongoing biological therapy for asthma (e.g., anti-IgE, anti-IL-5, anti-IL-4R)
- Severe asthma as per GINA criteria
- Recent asthma exacerbation requiring hospitalization or steroid burst (<3 months)
- Presence of other chronic autoimmune or inflammatory diseases
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 |
|---|---|---|
| Omnivorous dietParticipants will follow an individually planned, nutritionally adequate, isocaloric omnivorous diet for 12 weeks. Diet plans will be prepared by a clinical dietitian. Adherence will be monitored 3-day food diaries, weekly remote consultations, and digital tools. Participants will receive vitamin D supplementation (2000 IU/day). | Behavioural | Omnivorous diet, asthmatic individuals, Omnivorous diet, healthy individuals |
| Vegan dietParticipants will follow an individually planned, nutritionally adequate isocaloric vegan diet for 12 weeks. Diet plans will be prepared by a clinical dietitian. Adherence will be monitored 3-day food diaries, weekly remote consultations, and digital tools. Participants will receive vitamin D supplementation (2000 IU/day) and vitamin B12 supplementation according to standard recommendations. | Behavioural | Vegan diet, asthmatic individuals, Vegan diet, healthy individuals |
Primary outcome
Change in hsCRP levels
Time frame: Baseline and after week 12
Change in serum high-sensitivity C-reactive protein (hsCRP) concentration as a marker of systemic inflammation.
Change in IL-4 levels
Time frame: Baseline and after week 12
Change in serum interleukin-4 (IL-4) levels as an indicator of Th2-mediated inflammatory response.
Change in IL-5 levels
Time frame: Baseline and after week 12
Change in serum interleukin-5 (IL-5) levels as a marker of eosinophilic inflammation.
Change in IL-13 levels
Time frame: Baseline and after week 12
Change in serum interleukin-13 (IL-13) levels associated with allergic airway inflammation.
Change in TNF-α levels
Time frame: Baseline and after week 12
Change in tumor necrosis factor alpha (TNF-α) levels as a marker of systemic inflammatory activity.
14 secondary outcomes
Change in lymphocyte subpopulations
Time frame: Baseline and after week 12
Change in serum IgE levels
Time frame: Baseline and after week 12
Change in serum IgA levels
Time frame: Baseline and after week 12
Change in serum IgG levels
Time frame: Baseline and after week 12
Change in IgG subclasses
Time frame: Baseline and after week 12
Change in fractional exhaled nitric oxide (FeNO)
Time frame: Baseline and after week 12
Change in spirometry parameters
Time frame: Baseline and after week 12
Change in Asthma Control Test (ACT) score
Time frame: Baseline and after week 12
Change in lipid profile
Time frame: Baseline and after week 12
Change in body weight
Time frame: Baseline and after week 12
Change in body mass index (BMI)
Time frame: Baseline and after week 12
Change in waist circumference
Time frame: Baseline and after week 12
Change in waist-to-hip ratio (WHR)
Time frame: Baseline and after week 12
Change in body composition
Time frame: Baseline and after week 12
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 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Omnivorous diet and Vegan diet in people with Asthma and Dietary Intervention, run by Medical University of Gdansk.
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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in hsCRP levels (time frame: Baseline and after week 12). The study lists 5 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 18 Mar 2026.