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:
Medical University of Gdansk
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VEGASTHMA
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: