Healthy IndividualsFIRE-Diet-PNCT06157398
Diet Intervention Pilot: Refining a Meal and Food Delivery Approach
A study testing Increased EPA, DHA, fruit, and vegetable intake in people with Healthy Individuals, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Increased EPA, DHA, fruit, and vegetable intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2024to 5 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy Individuals
- Being tested
- Increased EPA, DHA, fruit, and vegetable intake
- Keywords
- Diet Intervention, EPA, DHA, Omega-3 fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased EPA, DHA, fruit, and vegetable intakeOther
Participants will receive food deliveries for approximately 4-weeks via online ordering, meal delivery, and dietician counseling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Increased EPA, DHA, fruit, and vegetable intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion (approximately 5 weeks/participant)
Secondary outcomes (1)
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)
Measured: From initiation of diet intervention to study completion (approximately 4 weeks/participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start29 Jan 2024
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Brigham, University of British Columbia
- Investigators
- Emily Brigham, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157398
- Sponsor's protocol ID
- H22-02546
- Acronym
- FIRE-Diet-P
- Status last verified
- Jan 2024
- First submitted
- 11 Aug 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Intervention Pilot: Refining a Meal and Food Delivery Approach
- ClinicalTrials.gov ID
- NCT06157398
- Acronym / sponsor ID
- FIRE-Diet-P / H22-02546
- Conditions
- Healthy Individuals
- Keywords
- Diet Intervention, EPA, DHA, Omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet Intervention | Other | Other: Increased EPA, DHA, fruit, and vegetable intakeParticipants 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased EPA, DHA, fruit, and vegetable intakeParticipants will receive food deliveries for approximately 4-weeks via online ordering, meal delivery, and dietician counseling. | Other | Diet Intervention |
Primary outcome
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
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
1 secondary outcome
Feasibility: Protocol adherence (dietary change)
Time frame: From initiation of diet intervention to study completion (approximately 4 weeks/participant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Brigham, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased EPA, DHA, fruit, and vegetable intake in people with Healthy Individuals, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment success (time frame: Through study completion (approximately 5 weeks/participant)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.