University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
NCT Number: NCT06157398
A diet with a higher intake of fish and fruits, and vegetables, has shown promise in reducing inflammation and oxidative stress in the body. Intake of a diet with these components has been linked to fewer respiratory symptoms and lower rates of lung disease in multiple studies. In addition, emerging research suggests that a diet with these components may have the power to protect the body against some of the effects of exposure to air pollution.
In this study, participants will receive food, meals, and counseling designed to increase their dietary intake of fish, fruits, and vegetables. The research team will test the change in diet and learn ways to optimize the participants' experience.
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Notify Me19 year–40 year
All sexes
Interventional
Not applicable
Vancouver, British Columbia, V5Z 1M9, Canada
This study is anticipated to enroll up to 30 participants, who will be asked to complete a total of 3 visits to Vancouver General Hospital. The study will take at least 5 weeks to complete, and participants will be asked to dedicate about 11.5 hours of their time for the entire study, including 4 phone calls. The principal investigator may request to access their health records for medication or past medical history to ensure their safe participation in the study.
Participants will receive at least weekly home delivery of foods and meals to meet the nutritional goals of the dietary intervention, which include:
To meet this goal, a study dietician will call participants weekly to assist in ordering fruits and vegetables of their choice that meet the needs of the study and assist them in some aspects of meal planning related to these orders. These fruits and vegetables will arrive by commercially-available grocery delivery.
To meet these goals, the study dietician will also assist participants in ordering weekly, prepared, microwaveable meals from a meal delivery service. Participants will receive four fish meals per week, which will meet the requirements of this average daily intake; participants are not required to (nor is it necessary to) eat fish every day.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
These inclusion and exclusion criteria align with the anticipated inclusion criteria for an upcoming diet and air pollution exposure study for which this pilot is informing the dietary intervention.
Participants will receive food deliveries for approximately 4-weeks via online ordering, meal delivery, and dietician counseling.
Time frame: Through study completion (approximately 5 weeks/participant)
Measures of recruitment success informing feasibility will include:
Ratio of # in-person screens/# telephone pre-screening Ratio of # participants enrolled/# telephone pre-screening Ratio of # participants enrolled/# in-person screens
Time frame: Through study completion (approximately 5 weeks/participant)
Measures of protocol completion informing feasibility will include:
Time frame: From initiation of diet intervention to study completion (approximately 4 weeks/participant)
Protocol adherence informing measurable change will be evaluated as follows:
% completion of 24-hour recalls (6 planned per participant) Change in within-individual reported servings of fruit and vegetables across 4-week intervention (Wilcoxon matched pairs signed rank test) Change in within-individual reported servings of fish across 4-week intervention (Wilcoxon matched pairs signed rank test) Change in within-individual reported grams of omega-3 intake across initial 2 weeks and full 4-weeks of intervention (paired sample t-test) Change in blood biomarker (omega-3, carotenoid, LDL, HDL, total cholesterol) levels across initial 2 weeks and full 4-weeks of intervention (paired sample t-test)
Time frame: Through study completion (approximately 5 weeks/participant)
Feedback provided at in-person visits 2 and 3 will be reviewed and described via qualitative interview. No formal statistical analysis is planned, and these results will be published.
University of British Columbia
Other
Acronym: FIRE-Diet-P
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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