Can Astaxanthin Help Manage Asthma in POlluted Areas?
Recruiting · NCT07507682 · Interventional (participants receive a specific treatment) · Lead sponsor: Middlesex University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study will test whether astaxanthin, a naturally occurring antioxidant supplement, can improve lung function, reduce airway inflammation, and improve asthma control in adults with mild-to-moderate asthma. Participants will receive astaxanthin and placebo in random order in a double-blind crossover design. Each treatment period lasts 4 weeks and is separated by a 3-week washout period. The study also measures indoor and personal air pollution exposure to examine whether pollution influences asthma symptoms, airway responsiveness, and response to treatment. Exploratory thoracic bioelectrical impedance spectroscopy will be assessed alongside standard respiratory tests.
Who can take part
Inclusion criteria
- Adults 18+ y
- Confirmed clinical diagnosis of mild-to-moderate asthma, defined as:
- A physician diagnosed asthma condition consistent with BTS/NICE/SIGN (2024)
- Asthma managed at GINA (2024) step 1-3 therapy level, with stable maintenance treatment for ≥4 weeks prior to enrolment
- No asthma exacerbation requiring systemic corticosteroids within the preceding 6-8 weeks
- those with suspected Asthma will be invited to a familiarisation and eligibility session where they will have clinical investigations to assess for asthma and thus be included or excluded)
- Ability to demonstrate acceptable and repeatable spirometry in accordance with ATS/ERS standards
- Willing to refrain from antioxidant and anti-inflammatory supplementation (e.g. Omega-3, turmeric, NSAID supplements) for the duration of the study
- Not consuming high dietary ASTX sources (e.g., frequent salmonid or crustacean intake), assessed at screening
- non-smoking and non-vaping
- Able and willing to take daily study capsules and attend all required visits
- Able and willing to complete home monitoring, including peak flow, air-quality monitoring, and questionnaires
- Able to provide written informed consent
Exclusion criteria
- Current smokers or vapers which is associated with chronic airway remodelling, reduce hyperresponsiveness to bronchodilators, and increased neutrophilic inflammation, which can obscure the true effects of asthma-target interventions
- Respiratory tract infection within the preceding 4 weeks
- Pregnant or lactating individuals
- Presence of significant co-morbidities, including CVD or autoimmune or systemic inflammatory diseases
- Renal or gastrointestinal disorders that may affect astaxanthin absorption and metabolism
- Known allergy or hypersensitivity to ASTX or any components of the study supplement
- History of current evidence of alcohol or substance abuse
- Participation in another interventional drug or supplement study within the preceding 3 months
- Use of medicines with a narrow therapeutic index where supplement interactions may pose risk (e.g., ciclosporin/tacrolimus, warfarin), assessed by investigator
- Other significant chronic respiratory disease (e.g., COPD, bronchiectasis)
Where it is running
1 location listed.
- Middlesex University - London, Barnet, United Kingdom