Can Astaxanthin Help Manage Asthma in POlluted Areas?

ConditionsAsthma (Diagnosis)Airway Inflammation Airway Hyperresponsiveness

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMiddlesex University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults 18+ y

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Astaxanthin Oral Capsule
Dietary supplement
Natural astaxanthin derived primarily from Haematococcus pluvialis, administered orally as three 4 mg capsules daily (total 12 mg/day) with the participant's largest meal for 4
Matched Placebo (Capsules)
Dietary supplement
Matched placebo capsules administered orally once daily as three capsules with the participant's largest meal for 4 weeks.

Treatment groups

25 Participants

are divided into 2 treatment groups

Group A: Sequence A: Astaxanthin Then PlaceboExperimental treatment 2 interventions

Group B: Sequence B: Placebo Then AstaxanthinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in Forced Expiratory Volume in 1 Second (FEV1)

FEV1 measured by spirometry using a calibrated Medisoft BodyBox system. Comparison is within-participant change after astaxanthin versus placebo.

Time frame

Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period

Change in Fractional Exhaled Nitric Oxide (FeNO)

FeNO measured in parts per billion using the NIOX VERO analyser. Comparison is within-participant change after astaxanthin versus placebo.

Time frame

Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period

Change in Airway Hyperresponsiveness During Hypertonic Saline Challenge

Hypertonic saline challenge response quantified using the dose response slope

Time frame

Measured at period-specific baseline and end of each 4-week treatment period

Secondary outcomes

Change in Impulse Oscillometry Resistance at 5 Hz (R5)

R5 measured during tidal breathing using the PulmoScan system

Time frame

Baseline, end of phase 1, post washout and end of phase 2

Change in Impulse Oscillometry Area of Reactance (AX)

AX measured using the PulmoScan system as an index of peripheral airway involvement.

Time frame

Baseline, end of phase 1, post washout and end of phase 2

Change in Asthma Control Questionnaire-6 (ACQ-6) Total Score

Participant-reported asthma control measured using the ACQ-6.

Time frame

Weekly during the 11- to 12-week study period

Change in Asthma Quality of Life Questionnaire (AQLQ) Total Score

Every 2 weeks during the 11- to 12-week study period

Time frame

Participant-reported asthma-related quality of life measured using the AQLQ.

Other outcomes

Change in Thoracic Bioelectrical Impedance Spectroscopy Phase Angle

Exploratory TBIS measure obtained using the BodyStat Multiscan 500 to assess feasibility and physiological coherence relative to standard respiratory measures

Time frame

Baseline, end of phase 1, post washout and end of phase 2. And supplementary changes during hypertonic saline challenge testing