University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
Location status: Recruiting
Location contact
Agnes CY Yuen, BSc
CONTACT
604-875-4111 ext. 66455
Agustin Bueso, BSc
CONTACT
604-875-4111 ext. 23177
NCT Number: NCT06711614
Research suggests that consuming more fatty fish, fruits, and vegetables could potentially shield the lungs from the negative impacts of air pollution. The research team will look at whether a dietary intervention aimed at increasing intake of these foods can protect the lungs from woodsmoke as the air pollutant and look into how this works.
Interested in participating?
Request Info19 year–40 year
All sexes
Interventional
Not applicable
Vancouver, British Columbia, V5Z 1M9, Canada
Location status: Recruiting
Agnes CY Yuen, BSc
CONTACT
604-875-4111 ext. 66455
Agustin Bueso, BSc
CONTACT
604-875-4111 ext. 23177
This study aims to recruit 48 healthy adult volunteer participants (24 male and 24 female biologic sex assigned at birth) with no known respiratory diseases (as assessed by the study physician) who will breathe in woodsmoke while they are supported to eat a diet higher in fatty fish, fruits, and vegetables (the intervention diet), or not (the control diet).
All participants will undergo a screening visit to assess eligibility for the study. Once deemed eligible, they will experience three exposure visits: one fresh air (filtered air - FA) exposure and two woodsmoke (WS) exposures. The study will span a minimum duration of 15 weeks with 10 in-person visits to the site at Vancouver General Hospital, totaling approximately 34.5 hours. During these visits, participants will complete a series of questionnaires, sample collections (blood, urine, sputum (clumps of mucus that are coughed up from the lungs)), and lung function tests, in addition to the exposures mentioned above.
Off-site commitments will require participants to follow the recommended diet assigned at the time, complete some electronic questionnaires and breathing tests at home after exposures, and complete telephone calls with the study dietician (approximately 30-minute calls, weekly).
Participants will be provided with meal and grocery deliveries to meet intake goals specified by the study or a subsidized amount of groceries per week depending on the diet intervention assigned at that time.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Designed to increase Omega-3 Fatty Acids (Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)), fruit, and vegetable intake, participants will receive grocery and meal deliveries for approximately 4-weeks via online ordering with dietician counselling.
Participants will receive weekly food subsidies for their groceries for 4-weeks (~equivalent to the subsidies to provide groceries in the Intervention arm) but are free to purchase whatever they wish. The participants will continue to have dietician counseling during this time.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in sputum neutrophil %, compared across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks
Within-individual change in sputum neutrophil activation (expression of neutrophil activation cell surface markers, release of neutrophil elastase and myeloperoxidase), and neutrophil function (phagocytosis, intracellular oxidative burst, and extracellular trap formation) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in airway resistance, as measured by impulse oscillometry (resonant frequency (Fres) and peripheral airway resistance (R5-R20)) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in sputum biomarkers of inflammation (IL-6, IL-8, and TNF-alpha in sputum as well as fractional exhaled nitric oxide) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in sputum biomarkers of inflammation (MCP-1, IL-4, IL-5, IL-13, protectins, maresins, resolvins) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in biomarkers of neutrophil activation (myeloperoxidase, neutrophil elastase in nasal epithelial lining fluid) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in biomarkers of inflammation (including IL-6, IL-8, TNF-alpha, MCP-1, IL-4, IL-5, IL-13, protectins, resolvins, maresins in nasal epithelial lining fluid) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in blood neutrophil %, compared across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks
Within-individual change in blood neutrophil activation (expression of neutrophil activation cell surface markers, release of neutrophil elastase and myeloperoxidase), and neutrophil function (phagocytosis, intracellular oxidative burst, and extracellular trap formation) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in spirometry, as measured by (Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and FEV1/FVC) across Intervention and Control Diet periods post wood smoke exposures.
Time frame: Across study duration, anticipated ~15 weeks.
Within-individual change in systemic biomarkers/arbiters of inflammation (including IL-6, IL-8, TNF-alpha, MCP-1, IL-4, IL-5, IL-13, resolvins, maresins, protectins in blood) and oxidative stress (including urinary leukotrienes) across Intervention and Control Diet periods post wood smoke exposures.
Contact information is provided by the study sponsor or research team.
University of British Columbia
Other
Acronym: FIRE-Diet-M
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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