FIRE-Diet: Food as an Intervention to Reduce the Effects of Woodsmoke Exposure on Respiratory Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-40
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Intervention Diet

    Other intervention

    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.

  • Control Diet

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Intervention Diet First, then Control DietOther 2 interventions
Group B: Control Diet First, then Intervention DietOther 2 interventions

Trial outcomes

Primary outcomes

1

Within-individual change in sputum neutrophil %

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.
2

Within-individual change in sputum neutrophil activation and function

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
3

Within-individual change in airway resistance

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.
4

Within-individual change in sputum biomarkers of inflammation

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.

Secondary outcomes

1

Within-individual change in sputum biomarkers/arbiters of inflammation

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.
2

Within-individual change in upper airway (nasal) markers of neutrophil activation and function

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.
3

Within-individual change in upper airway (nasal) biomarkers/arbiters of inflammation

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.
4

Within-individual change in blood neutrophil %

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.

Other outcomes

1

Within-individual change in systemic biomarkers/arbiters of inflammation and oxidative stress

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.

Time frame
Across study duration, anticipated ~15 weeks.

Sponsors and contacts

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