Health Claim ImplementationNCT05088863
Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging
A study testing flaxseed in people with Health Claim Implementation, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
A survey designed to examine how consumers adapt their diet in response to health claim messaging. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Claim Implementation
- What is being tested?
- flaxseed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteCanada
- Study dates
- 3 Mar 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman, age ≥18 years;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study;
- Have a mailing address in the Winnipeg census metropolitan area (City of Winnipeg and the municipalities of West St. Paul, East St. Paul, Headingley, Macdonald, Richot, Tache, Springfield, Rosser, St. Francois Xavier and St. Clements)4.
Who cannot join
- Allergy, aversion or unwillingness to eat whole ground flaxseed;
- Consuming ≥40g whole ground flaxseed/day;
- A family member within the same household is participating or has participated in this study;
- Currently participating in a food trial or dietary program that does not allow change in food choice.
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
I. H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
Heather J Blewett, PhD, 204-237-2954, hblewett@sbrc.ca
Heather J Blewett, PhD
About this study
A survey designed to examine how consumers adapt their diet in response to health claim messaging.
Read the detailed description
384 participants will be recruited to participate (n=32/group) ensuring equal numbers based on gender (men and women), income (low and medium-high), and age (18-35, 36-55, >56 years). Participants will be asked to prepare a 3-day food record representative of their current dietary intake. Participants will then be told, "Health Canada has approved the following health claim: 40g of ground flaxseed per day has been shown to help lower cholesterol, which is a risk factor for heart disease." Without any further guidance, participants will then be asked to modify their diet to achieve 40g per day of flaxseeds for the following 2 weeks. They will be asked to prepare another 3-day food record so we can see if/how their diet changed. At the end of the 2-week period, participants will be asked if they were successful with the changes and what barriers they faced in implementing these changes. This survey will be accomplished remotely with informed consent and communication with participants happening over the phone or videoconference. Participants will mail the food records to clinical trial staff. Analysis of food records will identify the food choices used to achieve dietary change, if these changes altered nutrient intake compared to their usual diet and if they were able to achieve the target laid out (ie. 40g flaxseed per day). A questionnaire will be used to identify barriers to implementation of dietary change (ie. price, availability, sensory aspects of food, ease of preparation).
- Conditions
- Health Claim Implementation
- Being tested
- flaxseed
- Keywords
- health claim, flax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flaxseedOther
40g of flaxseed per day
| Study group | Role | What they receive |
|---|---|---|
| Implementation of health claim | Other | Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet Receives: Other: flaxseed |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-day food record to assess food choices to achieve health claim
A list of flax containing foods from the 3-day food record will be created and the frequency with which each food item was selected will be recorded.
Measured: Two weeks
Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim
3 day food records before and after change in diet to address health claim will be entered into nutrition analysis software to calculate nutrient intake
Measured: Four weeks
Were they able to achieve the target laid out in the health claim
Questionnaire to identify barriers to implementation of health claim
Measured: 2 weeks
Secondary outcomes (1)
Barriers to implementation of dietary change
Questionnaire to identify if price, availability, sensory aspects of food, ease of preparation are barriers to implementation of the health claim
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start3 Mar 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Claim ImplementationStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dr. Heather Blewett, St. Boniface Hospital
- Investigators
- Heather Blewett, PhD, Principal investigator, Agriculture and Agri-Food Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088863
- Sponsor's protocol ID
- HS25165 (B2021:102)
- Other IDs
- HS25165 (B2021:102)
- Status last verified
- Nov 2024
- First submitted
- 6 Oct 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Kaur A, Scarborough P, Rayner M. A systematic review, and meta-analyses, of the impact of health-related claims on dietary choices. Int J Behav Nutr Phys Act. 2017 Jul 11;14(1):93. doi: 10.1186/s12966-017-0548-1.
PubMed 28697787
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging
- ClinicalTrials.gov ID
- NCT05088863
- Acronym / sponsor ID
- HS25165 (B2021:102)
- Conditions
- Health Claim Implementation
- Keywords
- health claim, flax
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Oct 2021 (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 survey designed to examine how consumers adapt their diet in response to health claim messaging.
Detailed description
384 participants will be recruited to participate (n=32/group) ensuring equal numbers based on gender (men and women), income (low and medium-high), and age (18-35, 36-55, >56 years). Participants will be asked to prepare a 3-day food record representative of their current dietary intake. Participants will then be told, "Health Canada has approved the following health claim: 40g of ground flaxseed per day has been shown to help lower cholesterol, which is a risk factor for heart disease." Without any further guidance, participants will then be asked to modify their diet to achieve 40g per day of flaxseeds for the following 2 weeks. They will be asked to prepare another 3-day food record so we can see if/how their diet changed. At the end of the 2-week period, participants will be asked if they were successful with the changes and what barriers they faced in implementing these changes. This survey will be accomplished remotely with informed consent and communication with participants happening over the phone or videoconference. Participants will mail the food records to clinical trial staff. Analysis of food records will identify the food choices used to achieve dietary change, if these changes altered nutrient intake compared to their usual diet and if they were able to achieve the target laid out (ie. 40g flaxseed per day). A questionnaire will be used to identify barriers to implementation of dietary change (ie. price, availability, sensory aspects of food, ease of preparation).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation of health claim | Other | Other: flaxseedParticipants will have 2 weeks to incorporate 40g of flaxseed per day into their diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or woman, age ≥18 years;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study;
- Have a mailing address in the Winnipeg census metropolitan area (City of Winnipeg and the municipalities of West St. Paul, East St. Paul, Headingley, Macdonald, Richot, Tache, Springfield, Rosser, St. Francois Xavier and St. Clements)4.
Key exclusion criteria (5 listed)
- Allergy, aversion or unwillingness to eat whole ground flaxseed;
- Consuming ≥40g whole ground flaxseed/day;
- A family member within the same household is participating or has participated in this study;
- Currently participating in a food trial or dietary program that does not allow change in food choice.
- Pregnant or lactating
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 |
|---|---|---|
| flaxseed40g of flaxseed per day | Other | Implementation of health claim |
Primary outcome
3-day food record to assess food choices to achieve health claim
Time frame: Two weeks
A list of flax containing foods from the 3-day food record will be created and the frequency with which each food item was selected will be recorded.
Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim
Time frame: Four weeks
3 day food records before and after change in diet to address health claim will be entered into nutrition analysis software to calculate nutrient intake
Were they able to achieve the target laid out in the health claim
Time frame: 2 weeks
Questionnaire to identify barriers to implementation of health claim
1 secondary outcome
Barriers to implementation of dietary change
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 28697787Kaur A, Scarborough P, Rayner M. A systematic review, and meta-analyses, of the impact of health-related claims on dietary choices. Int J Behav Nutr Phys Act. 2017 Jul 11;14(1):93. doi: 10.1186/s12966-017-0548-1.
- City of Winnipeg. Population of Winnipeg. April 2021:Link provided by the sponsor.
- Statistics Canada. Table 11-10-0241-01 Low income cut-offs (LICOs) before and after tax by community size and family size, in current dollars DOI:Link provided by the sponsor.
- 5\. Statistics Canada. Question #17 on the 2016 Census of Population 2A-L questionnaire:Link provided by the sponsor.
- 2\. Summary of Health Canada's Assessment of a Health Claim about Ground Whole Flaxseed and Blood Cholesterol LoweringLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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.
Heather Blewett, PhD principal investigator
Agriculture and Agri-Food Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flaxseed in people with Health Claim Implementation, run by St. Boniface Hospital 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Blewett, PhD (204 237-2954, heather.blewett@agr.gc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-day food record to assess food choices to achieve health claim (time frame: Two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088863, which also lists 1 linked publication.
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 29 Nov 2024.