Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMedical University of Gdansk
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Omnivorous diet
BehavioralParticipants 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 diet
BehavioralParticipants 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.
Treatment groups
280 Participants
are divided into 4 treatment groupsGroup A: Omnivorous diet, healthy individualsActive comparator 1 intervention
Group B: Vegan diet, healthy individualsExperimental treatment 1 intervention
Group C: Omnivorous diet, asthmatic individualsActive comparator 1 intervention
Group D: Vegan diet, asthmatic individualsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in hsCRP levels
Change in serum high-sensitivity C-reactive protein (hsCRP) concentration as a marker of systemic inflammation.
Time frame
Baseline and after week 122
Change in IL-4 levels
Change in serum interleukin-4 (IL-4) levels as an indicator of Th2-mediated inflammatory response.
Time frame
Baseline and after week 123
Change in IL-5 levels
Change in serum interleukin-5 (IL-5) levels as a marker of eosinophilic inflammation.
Time frame
Baseline and after week 124
Change in IL-13 levels
Change in serum interleukin-13 (IL-13) levels associated with allergic airway inflammation.
Time frame
Baseline and after week 12Secondary outcomes
1
Change in lymphocyte subpopulations
Changes in lymphocyte subpopulations including CD4+, CD8+, CD4+/CD8+ ratio, and Treg cells
Time frame
Baseline and after week 122
Change in serum IgE levels
Change in immunoglobulin E concentration associated with allergic inflammation.
Time frame
Baseline and after week 123
Change in serum IgA levels
Change in immunoglobulin A concentration reflecting mucosal immune function.
Time frame
Baseline and after week 124
Change in serum IgG levels
Change in total immunoglobulin G concentration.
Time frame
Baseline and after week 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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