Can Astaxanthin Help Manage Asthma in POlluted Areas?

March 27, 2026 updated by: Ahmet N Celen, Middlesex University

Investigating Astaxanthin as a Novel Therapy for Asthma Management in Polluted Environments

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo-controlled, 2-sequence, 2-period crossover trial in 25 non-smoking, non-vaping adults aged 18 to 59 years with mild-to-moderate asthma or asthma-like symptoms confirmed at screening. Participants will be allocated 1:1 to one of two treatment sequences: astaxanthin followed by placebo, or placebo followed by astaxanthin. Each intervention period lasts 4 weeks and is separated by a 3-week washout. Astaxanthin will be given orally at a total dose of 12 mg/day as three 4 mg capsules taken with the participant's largest meal; placebo capsules will be matched. Outcome assessments include FeNO, spirometry, impulse oscillometry, body plethysmography, hypertonic saline challenge with induced sputum collection, home peak expiratory flow monitoring, questionnaires, and exploratory thoracic bioelectrical impedance spectroscopy. Indoor and personal air pollution exposures will be measured throughout the study to evaluate whether pollution modifies respiratory outcomes and treatment response.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Dr Lygeri Dimitriou
  • Phone Number: +44 7813 356883

Study Locations

  • United Kingdom
    • Barnet
      • London, Barnet, United Kingdom, NW4 4BT
        • Recruiting
        • Middlesex University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence A: Astaxanthin Then Placebo
Participants receive astaxanthin 12 mg/day orally for 4 weeks, followed by a 3-week washout, then matched placebo orally for 4 weeks.
Dietary supplement: Astaxanthin Oral Capsule
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
Dietary supplement: Matched Placebo (Capsules)
Matched placebo capsules administered orally once daily as three capsules with the participant's largest meal for 4 weeks.
Experimental: Sequence B: Placebo Then Astaxanthin
Participants receive matched placebo orally for 4 weeks, followed by a 3-week washout, then astaxanthin 12 mg/day orally for 4 weeks.
Dietary supplement: Astaxanthin Oral Capsule
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
Dietary supplement: Matched Placebo (Capsules)
Matched placebo capsules administered orally once daily as three capsules with the participant's largest meal for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period
FEV1 measured by spirometry using a calibrated Medisoft BodyBox system. Comparison is within-participant change after astaxanthin versus placebo.
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)
Time Frame: Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period
FeNO measured in parts per billion using the NIOX VERO analyser. Comparison is within-participant change after astaxanthin versus placebo.
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
Time Frame: Measured at period-specific baseline and end of each 4-week treatment period
Hypertonic saline challenge response quantified using the dose response slope
Measured at period-specific baseline and end of each 4-week treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Impulse Oscillometry Resistance at 5 Hz (R5)
Time Frame: Baseline, end of phase 1, post washout and end of phase 2
R5 measured during tidal breathing using the PulmoScan system
Baseline, end of phase 1, post washout and end of phase 2
Change in Impulse Oscillometry Area of Reactance (AX)
Time Frame: Baseline, end of phase 1, post washout and end of phase 2
AX measured using the PulmoScan system as an index of peripheral airway involvement.
Baseline, end of phase 1, post washout and end of phase 2
Change in Asthma Control Questionnaire-6 (ACQ-6) Total Score
Time Frame: Weekly during the 11- to 12-week study period
Participant-reported asthma control measured using the ACQ-6.
Weekly during the 11- to 12-week study period
Change in Asthma Quality of Life Questionnaire (AQLQ) Total Score
Time Frame: Participant-reported asthma-related quality of life measured using the AQLQ.
Every 2 weeks during the 11- to 12-week study period
Participant-reported asthma-related quality of life measured using the AQLQ.
Change in Peak Expiratory Flow Amplitude Percent Mean (PEF APM)
Time Frame: Twice daily during each treatment period and washout, up to 11 to 12 weeks
Diurnal variability in peak expiratory flow derived from home morning and evening PEF
Twice daily during each treatment period and washout, up to 11 to 12 weeks
Change in Sputum Eosinophil Percentage
Time Frame: Induced sputum cellular differential measured after hypertonic saline challenge.
Baseline, end of phase 1, post washout period and end of phase 2
Induced sputum cellular differential measured after hypertonic saline challenge.
Change in Sputum Interleukin-8 (IL-8) Concentration
Time Frame: IL-8 measured in processed induced sputum.
Baseline, end of phase 1, post washout and end of phase 2
IL-8 measured in processed induced sputum.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Thoracic Bioelectrical Impedance Spectroscopy Phase Angle
Time Frame: Baseline, end of phase 1, post washout and end of phase 2. And supplementary changes during hypertonic saline challenge testing
Exploratory TBIS measure obtained using the BodyStat Multiscan 500 to assess feasibility and physiological coherence relative to standard respiratory measures
Baseline, end of phase 1, post washout and end of phase 2. And supplementary changes during hypertonic saline challenge testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Middlesex University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstaReal
BodyStat Ltd.
British Pest Control Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lygeri Dimitriou, Middlesex University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ethics application ETH2425-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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