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

NCT05088863 | Recruiting

• 1 other identifier: HS25165 (B2021:102)
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Health Claim Implementation

Keywords

health claim; flax

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  Four weeks

• Were they able to achieve the target laid out in the health claim

  Questionnaire to identify barriers to implementation of health claim

  2 weeks

Secondary Outcomes (1)

• Barriers to implementation of dietary change

  2 weeks

Study Arms (1)

Implementation of health claim

OTHER

Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet

Other: flaxseed

Interventions

flaxseed OTHER

40g of flaxseed per day

Implementation of health claim

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender identity fits into one of two categories, man or woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Boniface Hospital: lead
• Agriculture and Agri-Food Canada: collaborator

Study Sites (1)

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 28697787 BACKGROUND

Related Links

• City of Winnipeg. Population of Winnipeg. April 2021:
• 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:
• 5\. Statistics Canada. Question #17 on the 2016 Census of Population 2A-L questionnaire:
• 2\. Summary of Health Canada's Assessment of a Health Claim about Ground Whole Flaxseed and Blood Cholesterol Lowering

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Heather Blewett, PhD

  Agriculture and Agri-Food Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Blewett, PhD

CONTACT

204 237-2954; heather.blewett@agr.gc.ca

Jo-Ann Stebbing, MSC

CONTACT

204 258-1209; jstebbing@sbrc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 22, 2021
• Study Start: March 3, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the time the data is collected until the manuscript is accepted for publication

Locations

CA (1)