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Dietary Supplement

Flaxseed for High Blood Pressure

Phase 2 & 3
Waitlist Available
Led By Grant N Pierce, Ph.D.
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 baseline, 2, 4, and 6 months
Awards & highlights

Study Summary

The World Health Organization has deemed high blood pressure as a global crisis because it is the number one risk factor associated with most deaths worldwide. Therefore, the need for effective and desirable treatment options is vitally necessary. The purpose of the current investigation is to determine the efficacy of a new therapeutic strategy: flaxseed. The aim is to determine the efficacy of consuming milled flaxseed every day for 6 months on the reduction of blood pressure in individuals newly diagnosed with high blood pressure yet to receive any blood pressure lowering medications. Secondary objectives are to understand how flaxseed at the molecular level can reduce blood pressure. The study hypothesis is that the flaxseed group will exhibit significant reductions in blood pressure and therefore not require any blood pressure lowering medication. The aim is to provide knowledge on a new therapeutic strategy to help manage high blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2, 4, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2, 4, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
averaged automated blood pressure

Side effects data

From 2016 Phase 2 & 3 trial • 110 Patients • NCT00781950
12%
Increased Claudication
5%
Nausea
5%
Stroke
3%
Rest Pain in Limbs
2%
Myocardial Infarction
2%
Ulcerative Cellulitis
2%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Flaxseed

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FlaxseedExperimental Treatment1 Intervention
30 grams of milled flaxseed on its own or baked into food products (ie: bagels, muffins, and snack bars)
Group II: Wheat/Mixed Dietary OilsPlacebo Group1 Intervention
A combination of wheat, pecans, and/or mixed dietary oils on its own or baked into food products (ie: bagels, muffins, and snack bars)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flaxseed
2012
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

St. Boniface HospitalLead Sponsor
51 Previous Clinical Trials
11,559 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,351 Previous Clinical Trials
26,459,661 Total Patients Enrolled
Grant N Pierce, Ph.D.Principal InvestigatorSt. Boniface Hospital Research Centre
~5 spots leftby Jun 2025