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Recruiting

NCT Number: NCT05088863

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

A survey designed to examine how consumers adapt their diet in response to health claim messaging.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location status: Recruiting

Location contact

Heather J Blewett, PhD

CONTACT

[email protected]

204-237-2954

Heather J Blewett, PhD

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Flaxseed

Other

40g of flaxseed per day

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. Barriers to implementation of dietary change

    Time frame: 2 weeks

    Questionnaire to identify if price, availability, sensory aspects of food, ease of preparation are barriers to implementation of the health claim

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Blewett, PhD

CONTACT

[email protected]

204 237-2954

Jo-Ann Stebbing, MSC

CONTACT

[email protected]

204 258-1209

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • Agriculture and Agri-Food Canada

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.