Recruiting

Observational Study

Sponsor:

St. Boniface Hospital

Code:

NCT05088863

Conditions

Health Claim Implementation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

flaxseed

Study Details

Brief summary:

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

Conditions

Health Claim Implementation

Study ID

NCT05088863

Start date

Mar 3, 2022

Status verified date

Nov, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

384 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Implementation of health claim

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

Interventions

flaxseed

40g of flaxseed per day

Primary outcome measure

  • 3-day food record to assess food choices to achieve health claim [ Time Frame: Two weeks ]
  • Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim [ Time Frame: Four weeks ]
  • Were they able to achieve the target laid out in the health claim [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

I. H. Asper Clinical Research Institute

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Heather J Blewett, PhD

204-237-2954hblewett@sbrc.ca

More Information

Sponsor

St. Boniface Hospital

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Keywords

  • health claim
  • flax

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Boniface Hospital on 2024-11-29.