Can Astaxanthin Help Manage Asthma in POlluted Areas?

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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
• Пищевая добавка Matched Placebo (Capsules)
  Matched placebo capsules administered orally once daily as three capsules with the participant's largest meal for 4 weeks.

Первичные конечные точки

• Change in Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Measured at period-specific baseline and end of each 4-week treatment period]

Вторичные конечные точки (7)

• Change in Impulse Oscillometry Resistance at 5 Hz (R5) [Срок оценки: Baseline, end of phase 1, post washout and end of phase 2]
• Change in Impulse Oscillometry Area of Reactance (AX) [Срок оценки: Baseline, end of phase 1, post washout and end of phase 2]
• Change in Asthma Control Questionnaire-6 (ACQ-6) Total Score [Срок оценки: Weekly during the 11- to 12-week study period]
• Change in Asthma Quality of Life Questionnaire (AQLQ) Total Score [Срок оценки: Participant-reported asthma-related quality of life measured using the AQLQ.]
• Change in Peak Expiratory Flow Amplitude Percent Mean (PEF APM) [Срок оценки: Twice daily during each treatment period and washout, up to 11 to 12 weeks]
• Change in Sputum Eosinophil Percentage [Срок оценки: Induced sputum cellular differential measured after hypertonic saline challenge.]
• Change in Sputum Interleukin-8 (IL-8) Concentration [Срок оценки: IL-8 measured in processed induced sputum.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Middlesex University — London

Идентификаторы

NCT: NCT07507682 · Ethics application ETH2425-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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