- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711614
FIRE-Diet: Food as an Intervention to Reduce the Effects of Woodsmoke Exposure on Respiratory Health (FIRE-Diet-M)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Agnes Yuen
- Phone Number: 66455 604-875-4111
- Email: agnes.yuen@ubc.ca
Study Contact Backup
- Name: Agustin Bueso
- Phone Number: 21721 604-875-4111
- Email: agustin.bueso@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- University of British Columbia
-
Contact:
- Agustin Bueso, BSc
- Phone Number: 23177 604-875-4111
- Email: agustin.bueso@ubc.ca
-
Contact:
- Agnes CY Yuen, BSc
- Phone Number: 66455 604-875-4111
- Email: agnes.yuen@ubc.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy, and specifically with no respiratory disease
- Not taking any supplements, or willing to abstain from supplement use for 4-weeks prior to study start and the whole duration of the study,
- Must currently consume, on average, less than 2 servings of fish per week and fewer than 5 servings of fruits and vegetables per day based on screening questionnaires.
- Must have a null GSTM1 genotype determined at screening.
- Must be able to provide a sufficient sputum sample during the screening visit.
Exclusion Criteria:
- Pregnant or planning to become pregnant during the study period.
- Health conditions that would pose an unacceptable risk of dietary change, or conditions that are uncontrolled based on principal investigator's judgement.
- Actively attempting to lose weight.
- Frequent wood smoke exposure (e.g. at home or employment).
- Unable to store provided meals and food safely.
- Food allergies/intolerance or food aversion preventing adherence to the intervention diet, or unwillingness/medically unable to adjust diet in line with the intervention.
- Relocation during the study period to an area which will prevent food delivery.
- History of smoking tobacco, marijuana, or and other substance or vaping within the past 6 months, or having smoked the equivalent of 0.5 pack-years ever.
- Body mass index (BMI) <18.5, as determined during the in-person screening visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention Diet First, then Control Diet
Participants will complete ~4 weeks of the Intervention Diet, followed by a washout period of at least 4 weeks, then ~4 weeks of the Control Diet.
At the end of each Diet period, participants will undergo a 2 hour controlled wood smoke exposure, following which outcome measures will be assessed.
|
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.
|
|
Other: Control Diet First, then Intervention Diet
Participants will complete ~4 weeks of the Control Diet, followed by a washout period of at least 4 weeks, then ~4 weeks of the Intervention Diet.
At the end of each Diet period, participants will undergo a 2 hour controlled wood smoke exposure, following which outcome measures will be assessed.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Within-individual change in sputum neutrophil activation and function
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.
|
Across study duration, anticipated ~15 weeks
|
|
Within-individual change in sputum neutrophil %
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.
|
Across study duration, anticipated ~15 weeks.
|
|
Within-individual change in airway resistance
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.
|
Across study duration, anticipated ~15 weeks.
|
|
Within-individual change in sputum biomarkers of inflammation
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.
|
Across study duration, anticipated ~15 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Within-individual change in blood neutrophil activation and function
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.
|
Across study duration, anticipated ~15 weeks
|
|
Within-individual change in sputum biomarkers/arbiters of inflammation
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.
|
Across study duration, anticipated ~15 weeks.
|
|
Within-individual change in upper airway (nasal) markers of neutrophil activation and function
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.
|
Across study duration, anticipated ~15 weeks.
|
|
Within-individual change in upper airway (nasal) biomarkers/arbiters of inflammation
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.
|
Across study duration, anticipated ~15 weeks.
|
|
Within-individual change in blood neutrophil %
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.
|
Across study duration, anticipated ~15 weeks.
|
|
Within-individual change in spirometry
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.
|
Across study duration, anticipated ~15 weeks.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Within-individual change in systemic biomarkers/arbiters of inflammation and oxidative stress
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.
|
Across study duration, anticipated ~15 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily Brigham, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H23-03904
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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