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

Sponsor
Medical University of Gdansk
Study ID
NCT07480369
Status
Not Yet Recruiting

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Conditions

  • Asthma
  • Dietary Intervention
  • Vegan Diet

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

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).
  • 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.

Study Details

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.

Key Dates

First listed
Mar 18, 2026
Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Omnivorous diet, healthy individuals
  • Experimental: Vegan diet, healthy individuals
  • Active Comparator: Omnivorous diet, asthmatic individuals
  • Experimental: Vegan diet, asthmatic individuals

Primary Outcome Measure

Change in hsCRP levels [ Time Frame: Baseline and after week 12 ]

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