Diet Intervention Pilot: Refining a Meal and Food Delivery Approach

NCT06157398 | Completed

• 1 other identifier: H22-02546
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Individuals

Keywords

Diet Intervention; EPA; DHA; Omega-3 fatty acids

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Through study completion (approximately 5 weeks/participant)

Secondary Outcomes (1)

• Feasibility: Protocol adherence (dietary change)

  From initiation of diet intervention to study completion (approximately 4 weeks/participant)

Other Outcomes (1)

• Acceptability of the Protocol

  Through study completion (approximately 5 weeks/participant)

Study Arms (1)

Diet Intervention

OTHER

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

Interventions

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.

Diet Intervention

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Emily Brigham, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 1. To inform feasibility and acceptability of the intervention for deployment in a future randomized control trial. 2. Optimization of the design and implementation of a dietary intervention aimed at increasing intake of fruits, vegetables, and Omega-3 fatty acids in fish.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: December 5, 2023
• Study Start: January 29, 2024
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-01

Locations

CA (1)