An interventional study of flaxseed in Health Claim Implementation, sponsored by St. Boniface Hospital. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by St. Boniface Hospital · Not applicable, Interventional, and Other
A survey designed to examine how consumers adapt their diet in response to health claim messaging.
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).
St. Boniface Hospital is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet
Other: flaxseed
40g of flaxseed per day
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.
Time frame: 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
Time frame: Four weeks
Were they able to achieve the target laid out in the health claim
Questionnaire to identify barriers to implementation of health claim
Time frame: 2 weeks
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
Time frame: 2 weeks
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: From the time the data is collected until the manuscript is accepted for publication
Started Mar 2022 (actual). Primary completion is estimated for Nov 2025, 44 months after the start.
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St. Boniface Hospital