Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:30 PM
Study NCT ID:
NCT07480369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067269', 'term': 'Diet, Vegan'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hsCRP levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in serum high-sensitivity C-reactive protein (hsCRP) concentration as a marker of systemic inflammation.'}, {'measure': 'Change in IL-4 levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in serum interleukin-4 (IL-4) levels as an indicator of Th2-mediated inflammatory response.'}, {'measure': 'Change in IL-5 levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in serum interleukin-5 (IL-5) levels as a marker of eosinophilic inflammation.'}, {'measure': 'Change in IL-13 levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in serum interleukin-13 (IL-13) levels associated with allergic airway inflammation.'}, {'measure': 'Change in TNF-α levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in tumor necrosis factor alpha (TNF-α) levels as a marker of systemic inflammatory activity.'}], 'secondaryOutcomes': [{'measure': 'Change in lymphocyte subpopulations', 'timeFrame': 'Baseline and after week 12', 'description': 'Changes in lymphocyte subpopulations including CD4+, CD8+, CD4+/CD8+ ratio, and Treg cells'}, {'measure': 'Change in serum IgE levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in immunoglobulin E concentration associated with allergic inflammation.'}, {'measure': 'Change in serum IgA levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in immunoglobulin A concentration reflecting mucosal immune function.'}, {'measure': 'Change in serum IgG levels', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in total immunoglobulin G concentration.'}, {'measure': 'Change in IgG subclasses', 'timeFrame': 'Baseline and after week 12', 'description': 'Changes in IgG subclasses including IgG1, IgG2, IgG3 and IgG4.'}, {'measure': 'Change in fractional exhaled nitric oxide (FeNO)', 'timeFrame': 'Baseline and after week 12', 'description': 'Measurement of airway inflammation assessed using fractional exhaled nitric oxide.'}, {'measure': 'Change in spirometry parameters', 'timeFrame': 'Baseline and after week 12', 'description': 'Changes in pulmonary function parameters (FEV1, FVC, FEV1/FVC)'}, {'measure': 'Change in Asthma Control Test (ACT) score', 'timeFrame': 'Baseline and after week 12', 'description': '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.'}, {'measure': 'Change in lipid profile', 'timeFrame': 'Baseline and after week 12', 'description': 'Changes in total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol, and triglycerides'}, {'measure': 'Change in body weight', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in body weight measured in kilograms during the intervention.'}, {'measure': 'Change in body mass index (BMI)', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in BMI calculated from weight and height (kg/m²).'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in waist circumference as a measure of central adiposity'}, {'measure': 'Change in waist-to-hip ratio (WHR)', 'timeFrame': 'Baseline and after week 12', 'description': 'Change in waist-to-hip ratio as a measure of body fat distribution.'}, {'measure': 'Change in body composition', 'timeFrame': 'Baseline and after week 12', 'description': 'Changes in fat mass and lean mass assessed by bioimpedance analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'asthma control', 'inflammation', 'inflammatory markers', 'immune response', 'vegan diet', 'plant-based diet', 'randomized control trial', 'dietary intervention'], 'conditions': ['Asthma', 'Dietary Intervention', 'Vegan Diet']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDietary 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.\n\nAssessments will be performed at baseline and after 12 weeks of intervention. Evaluated parameters will include:\n\n* Inflammatory markers: hsCRP, IL-4, IL-5, IL-13, TNF-α\n* Immune function markers: lymphocyte subpopulations (CD4+, CD8+, CD4+/CD8+ ratio, Treg cells by flow cytometry/ELISA) and immunoglobulins (IgE, IgA, IgG, IgG1-IgG4)\n* Respiratory function: fractional exhaled nitric oxide (FeNO), spirometry\n* Anthropometric and body composition measures: body weight, body mass index (BMI), waist circumference, waist-to-hip ratio, bioimpedance body composition analysis\n* Lipid profile: total cholesterol, HDL, LDL, non-HDL cholesterol, triglycerides\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all groups:\n\n* Aged 18-30 years\n* Willing to adhere to assigned dietary plan (vegan or omnivorous) for 12 weeks\n* Non-smoker for at least 5 years\n* Body mass index (BMI) between 18.5 and 24.9 kg/m2\n\nFor the asthma group:\n\n* Clinical diagnosis of mild or moderate asthma (GINA criteria), made at least 12 months before enrollment\n* Stable asthma status (no exacerbations or changes in therapy within the past 3 months)\n* No change in pharmacotherapy during the study period\n\nExclusion Criteria:\n\n* Use of systemic corticosteroids (oral or intravenous) within the past 3 months\n* Ongoing biological therapy for asthma (e.g., anti-IgE, anti-IL-5, anti-IL-4R)\n* Severe asthma as per GINA criteria\n* Recent asthma exacerbation requiring hospitalization or steroid burst (\\<3 months)\n* Presence of other chronic autoimmune or inflammatory diseases\n* Pregnancy or lactation\n* Active infection or acute illness at the time of recruitment\n* Adherence to specialized exclusion diets (e.g., ketogenic, low-FODMAP)\n* History of eating disorders\n* Inability or unwillingness to participate in follow-up visits or comply with the protocol'}, 'identificationModule': {'nctId': 'NCT07480369', 'acronym': 'VEGASTHMA', 'briefTitle': 'Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'The Effect of a Vegan Diet on Inflammatory and Immune Biomarkers in Adult Patients With Asthma and in Healthy Individuals: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KB/556-86/2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omnivorous diet, healthy individuals', 'interventionNames': ['Behavioral: Omnivorous diet']}, {'type': 'EXPERIMENTAL', 'label': 'Vegan diet, healthy individuals', 'interventionNames': ['Behavioral: Vegan diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omnivorous diet, asthmatic individuals', 'interventionNames': ['Behavioral: Omnivorous diet']}, {'type': 'EXPERIMENTAL', 'label': 'Vegan diet, asthmatic individuals', 'interventionNames': ['Behavioral: Vegan diet']}], 'interventions': [{'name': 'Omnivorous diet', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['Omnivorous diet, asthmatic individuals', 'Omnivorous diet, healthy individuals']}, {'name': 'Vegan diet', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Vegan diet, asthmatic individuals', 'Vegan diet, healthy individuals']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}