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Completed

NCT Number: NCT06157398

Diet Intervention Pilot: Refining a Meal and Food Delivery Approach

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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Key information

Conditions

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

  • An average daily intake of over 850 mg of omega-3 fatty acids (specifically eicosapentaenoic acid and docosahexaenoic acid, also known as EPA and DHA) from fish.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy: defined as no significant respiratory, cardiac, or metabolic disorders (e.g. obesity, diabetes)
  • No dietary supplement use (vitamins, fish oil, etc.), or willing to stop the use of supplements for one month prior to study initiation and during the study period (if the supplement is prescribed or physician-recommended, the participant will be excluded from participation)
  • No use of medications known to interact with diet composition (e.g. Coumadin)
  • At the time of enrolment, consuming less than 250 mg EPA+DHA daily (<2 servings fish/week) and <5 servings of fruit/vegetables per day, assessed by dietary screeners
  • Not actively participating in other studies that would provide conflict with this or the alternate study protocol

Exclusion criteria

  • Pregnant or planning to become pregnant during the study period
  • Actively attempting to lose weight
  • Food allergies/intolerance or food aversion preventing adherence to the intervention diet, or unwillingness/medically unable to adjust diet in line with the intervention
  • Plans to move outside of British Columbia during the study period
  • Lack of access to adequate food storage or food preparation appliances

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.

Treatment and study plan

Increased EPA, DHA, fruit, and vegetable intake

Other

Participants will receive food deliveries for approximately 4-weeks via online ordering, meal delivery, and dietician counseling.

Primary outcomes

  1. Feasibility: Recruitment success

    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

  2. Feasibility: Protocol completion

    Time frame: Through study completion (approximately 5 weeks/participant)

    Measures of protocol completion informing feasibility will include:

    • participants completing visit 1
    • participants completing visit 2
    • participants completing visit 3

Secondary outcomes

  1. Feasibility: Protocol adherence (dietary change)

    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)

Other outcomes

  1. Acceptability of the Protocol

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: FIRE-Diet-P

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2023
Registry last updated
Nov 27, 2024

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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