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

NCT07480369 | Not Yet Recruiting

• 1 other identifier: KB/556-86/2026
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma; Dietary Intervention; Vegan Diet

Keywords

asthma; asthma control; inflammation; inflammatory markers; immune response; vegan diet; plant-based diet; randomized control trial; dietary intervention

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (14)

• Change in lymphocyte subpopulations

  Baseline and after week 12

• Change in serum IgE levels

  Baseline and after week 12

• Change in serum IgA levels

  Baseline and after week 12

• Change in serum IgG levels

  Baseline and after week 12

• Change in IgG subclasses

  Baseline and after week 12

Study Arms (4)

Omnivorous diet, healthy individuals

ACTIVE COMPARATOR

Behavioral: Omnivorous diet

Vegan diet, healthy individuals

EXPERIMENTAL

Behavioral: Vegan diet

Omnivorous diet, asthmatic individuals

ACTIVE COMPARATOR

Behavioral: Omnivorous diet

Vegan diet, asthmatic individuals

EXPERIMENTAL

Behavioral: Vegan diet

Interventions

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).

Omnivorous diet, asthmatic individuals; Omnivorous diet, healthy individuals

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.

Vegan diet, asthmatic individuals; Vegan diet, healthy individuals

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of eating disorders
• Inability or unwillingness to participate in follow-up visits or comply with the protocol

Sponsors & Collaborators

• Medical University of Gdansk: lead

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03