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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnivorous diet, healthy individuals | Active Comparator |
| |
| Vegan diet, healthy individuals | Experimental |
| |
| Omnivorous diet, asthmatic individuals | Active Comparator |
| |
| Vegan diet, asthmatic individuals | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnivorous diet | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hsCRP levels | Change in serum high-sensitivity C-reactive protein (hsCRP) concentration as a marker of systemic inflammation. | 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. | Baseline and after week 12 |
| Change in IL-5 levels | Change in serum interleukin-5 (IL-5) levels as a marker of eosinophilic inflammation. | Baseline and after week 12 |
| Change in IL-13 levels | Change in serum interleukin-13 (IL-13) levels associated with allergic airway inflammation. | 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. | Baseline and after week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lymphocyte subpopulations | Changes in lymphocyte subpopulations including CD4+, CD8+, CD4+/CD8+ ratio, and Treg cells | Baseline and after week 12 |
| Change in serum IgE levels | Change in immunoglobulin E concentration associated with allergic inflammation. |
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Inclusion Criteria:
For all groups:
For the asthma group:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
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|
| Vegan diet | Behavioral | 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. |
|
| Baseline and after week 12 |
| Change in serum IgA levels | Change in immunoglobulin A concentration reflecting mucosal immune function. | Baseline and after week 12 |
| Change in serum IgG levels | Change in total immunoglobulin G concentration. | Baseline and after week 12 |
| Change in IgG subclasses | Changes in IgG subclasses including IgG1, IgG2, IgG3 and IgG4. | Baseline and after week 12 |
| Change in fractional exhaled nitric oxide (FeNO) | Measurement of airway inflammation assessed using fractional exhaled nitric oxide. | Baseline and after week 12 |
| Change in spirometry parameters | Changes in pulmonary function parameters (FEV1, FVC, FEV1/FVC) | 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. | Baseline and after week 12 |
| Change in lipid profile | Changes in total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol, and triglycerides | Baseline and after week 12 |
| Change in body weight | Change in body weight measured in kilograms during the intervention. | Baseline and after week 12 |
| Change in body mass index (BMI) | Change in BMI calculated from weight and height (kg/m²). | Baseline and after week 12 |
| Change in waist circumference | Change in waist circumference as a measure of central adiposity | 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. | Baseline and after week 12 |
| Change in body composition | Changes in fat mass and lean mass assessed by bioimpedance analysis | Baseline and after week 12 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |