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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
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 • NCT0095681336%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Implementation of health claim
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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