Menu
Not yet recruiting NCT07480369

Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults

No phase Interventional Asthma Dietary Intervention Vegan Diet

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omnivorous diet, Vegan diet.
Who it may be relevant to
Registry conditions: Asthma, Dietary Intervention, Vegan Diet. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Behavioral Omnivorous diet
    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).
  • Behavioral Vegan diet
    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.

Primary outcome measures

  • Change in hsCRP levels [Time frame: Baseline and after week 12]
  • Change in IL-4 levels [Time frame: Baseline and after week 12]
  • Change in IL-5 levels [Time frame: Baseline and after week 12]
  • Change in IL-13 levels [Time frame: Baseline and after week 12]
  • Change in TNF-α levels [Time frame: Baseline and after week 12]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

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:

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07480369 · KB/556-86/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗