Can Astaxanthin Help Manage Asthma in POlluted Areas?

NCT07507682 | Recruiting

• 1 other identifier: Ethics application ETH2425-008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma (Diagnosis); Airway Inflammation; Airway Hyperresponsiveness

Keywords

Astaxanthin; Mild-to-Moderate Asthma; Air Pollution; FeNO; Hypertonic Saline Challenge; Impulse Oscillometry; Thoracic Bioelectrical Impedance Spectroscopy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

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

Secondary Outcomes (7)

• Change in Impulse Oscillometry Resistance at 5 Hz (R5)

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

• Change in Impulse Oscillometry Area of Reactance (AX)

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

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

  Weekly during the 11- to 12-week study period

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

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

• Change in Peak Expiratory Flow Amplitude Percent Mean (PEF APM)

  Twice daily during each treatment period and washout, up to 11 to 12 weeks

Other Outcomes (1)

• Change in Thoracic Bioelectrical Impedance Spectroscopy Phase Angle

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

Study Arms (2)

Sequence A: Astaxanthin Then Placebo

EXPERIMENTAL

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; Dietary Supplement: Matched Placebo (Capsules)

Sequence B: Placebo Then Astaxanthin

EXPERIMENTAL

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; Dietary Supplement: Matched Placebo (Capsules)

Interventions

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

Sequence A: Astaxanthin Then Placebo; Sequence B: Placebo Then Astaxanthin

Matched Placebo (Capsules) DIETARY_SUPPLEMENT

Matched placebo capsules administered orally once daily as three capsules with the participant's largest meal for 4 weeks.

Sequence A: Astaxanthin Then Placebo; Sequence B: Placebo Then Astaxanthin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Middlesex University: lead
• AstaReal: collaborator
• BodyStat Ltd.: collaborator
• British Pest Control Association: collaborator

Study Sites (1)

Middlesex University

London, Barnet, NW4 4BT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma; Disease; Respiratory Hypersensitivity

Interventions

astaxanthine; Capsules

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Lygeri Dimitriou

  Middlesex University

  STUDY DIRECTOR

Central Study Contacts

Ahmet Celen, PhD in Biomedical Science

CONTACT

+447840475597; AC1534@live.mdx.ac.uk

Dr Lygeri Dimitriou

CONTACT

+44 7813 356883

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Model Details: Two-sequence, two-period crossover design. Participants are randomized 1:1 to Sequence A (astaxanthin then placebo) or Sequence B (placebo then astaxanthin). Each treatment period lasts 4 weeks and is separated by a 3-week washout period.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

GB (1)