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Dietary Changes Due to Health Claims Messaging

N/A
Recruiting
Led By Heather Blewett, PhD
Research Sponsored by St. Boniface Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial looks at how people change their diets when they see health claims on food packaging.

Who is the study for?
This survey is for men and women over 18 living in the Winnipeg area who are willing to change their diet based on health messages. They must not eat more than 40g of flaxseed daily, be part of another food trial, or have a household member in this study. Pregnant/lactating individuals or those allergic to flaxseed can't join.Check my eligibility
What is being tested?
The survey investigates how people might alter their eating habits when they receive messages about the health benefits of including flaxseed in their diets.See study design
What are the potential side effects?
Since this is a dietary survey rather than a drug trial, it does not directly test side effects; however, consuming flaxseed may cause mild digestive changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3-day food record to assess food choices to achieve health claim
Comparison of 3-day food records to assess change in nutrient intake from usual diet to diet addressing health claim
Were they able to achieve the target laid out in the health claim
Secondary outcome measures
Barriers to implementation of dietary change

Side effects data

From 2013 Phase 3 trial • 210 Patients • NCT00956813
36%
Flatulence
14%
Abdominal distension
8%
Diarrhea
7%
Nausea
4%
Vomiting
3%
Pruritus
1%
Anorexia
1%
Fatigue
1%
Dizziness
1%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Optional Continuation Period
Flaxseed
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Implementation of health claimExperimental Treatment1 Intervention
Participants will have 2 weeks to incorporate 40g of flaxseed per day into their diet

Find a Location

Who is running the clinical trial?

St. Boniface HospitalLead Sponsor
51 Previous Clinical Trials
11,225 Total Patients Enrolled
Agriculture and Agri-Food CanadaOTHER_GOV
33 Previous Clinical Trials
1,921 Total Patients Enrolled
Heather Blewett, PhDPrincipal InvestigatorAgriculture and Agri-Food Canada
6 Previous Clinical Trials
363 Total Patients Enrolled

Media Library

Implementation of health claim Clinical Trial Eligibility Overview. Trial Name: NCT05088863 — N/A
Health Claim Implementation Research Study Groups: Implementation of health claim
Health Claim Implementation Clinical Trial 2023: Implementation of health claim Highlights & Side Effects. Trial Name: NCT05088863 — N/A
Implementation of health claim 2023 Treatment Timeline for Medical Study. Trial Name: NCT05088863 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants for this research project?

"Affirmative. Data from clinicaltrials.gov shows that this trial is still open to applicants and was initially posted in March 3rd 2022 with the last amendment being applied on the 18th of March. Currently, 384 volunteers are needed for testing at one location."

Answered by AI

Are applications currently accepted for this clinical investigation?

"Affirmative. Per the clinicaltrials.gov listings, this medical trial is currently searching for 384 participants at a single site. This research project was originally published on March 3rd 2022 and has undergone its most recent update on 18th of March 2022."

Answered by AI
~170 spots leftby Nov 2025