An interventional study of Increased EPA, DHA, fruit, and vegetable intake in Healthy Individuals, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by University of British Columbia · Not applicable, Interventional, and Other
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.
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:
An average daily intake of 8-10 servings of fruits and vegetables high in antioxidants.
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.
University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 be provided with a diet that has an increased intake of fish high in Omega-3 fatty acids as well as fruits and vegetables in comparison to their baseline intakes as assessed by the study dietician.
Other: Increased EPA, DHA, fruit, and vegetable intake
Participants will receive food deliveries for approximately 4-weeks via online ordering, meal delivery, and dietician counseling.
Feasibility: Recruitment success
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)
Feasibility: Protocol completion
Measures of protocol completion informing feasibility will include: * participants completing visit 1 * participants completing visit 2 * participants completing visit 3
Time frame: Through study completion (approximately 5 weeks/participant)
Feasibility: Protocol adherence (dietary change)
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: From initiation of diet intervention to study completion (approximately 4 weeks/participant)
Acceptability of the Protocol
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.
Time frame: Through study completion (approximately 5 weeks/participant)
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of British Columbia