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Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging

Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05088863
Enrollment
384
Registered
2021-10-22
Start date
2022-03-03
Completion date
2025-11-30
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Claim Implementation

Keywords

health claim, flax

Brief summary

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).

Interventions

OTHERflaxseed

40g of flaxseed per day

Sponsors

Agriculture and Agri-Food Canada
CollaboratorOTHER_GOV
St. Boniface Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Man or woman, age ≥18 years; 2. Willing to provide informed consent; 3. Willing/able to comply with the requirements of the study; 4. 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.

Exclusion criteria

1. Allergy, aversion or unwillingness to eat whole ground flaxseed; 2. Consuming ≥40g whole ground flaxseed/day; 3. A family member within the same household is participating or has participated in this study; 4. Currently participating in a food trial or dietary program that does not allow change in food choice. 5. Pregnant or lactating

Design outcomes

Primary

MeasureTime frameDescription
3-day food record to assess food choices to achieve health claimTwo weeksA 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 claimFour weeks3 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 claim2 weeksQuestionnaire to identify barriers to implementation of health claim

Secondary

MeasureTime frameDescription
Barriers to implementation of dietary change2 weeksQuestionnaire to identify if price, availability, sensory aspects of food, ease of preparation are barriers to implementation of the health claim

Countries

Canada

Contacts

Primary ContactHeather Blewett, PhD
heather.blewett@agr.gc.ca204 237-2954
Backup ContactJo-Ann Stebbing, MSC
jstebbing@sbrc.ca204 258-1209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026