NCT01952340

The Efficacy of Dietary Flaxseed for the Reduction of Blood Pressure in Newly Diagnosed Hypertensive Individuals

A Phase II/III, Randomized, Double-Blinded, Controlled Clinical Trial to Investigate the Efficacy of Dietary Flaxseed for the Reduction of Blood Pressure in Newly Diagnosed Hypertensive Individuals

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: St. Boniface Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is a phase II/III, randomized, double-blinded, controlled clinical trial to determine the efficacy of dietary flaxseed as a therapeutic strategy to reduce blood pressure in newly diagnosed hypertensive individuals. The aim of the trial is to recruit 100 participants that have been clinically diagnosed with hypertension within 6 months and yet to receive any anti-hypertensive medication. The control and flax groups will be provided food products to consume on a daily basis for 6 months. Assessment parameters such as averaged automated blood pressure, anthropometrics, 24-food recall, physical activity questionnaire, and blood and urine analysis will be conducted at baseline, 2, 4, and 6 months.

Conditions

• Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Flaxseed	Milled flaxseed
DIETARY_SUPPLEMENT	Placebo	Wheat germ/wheat bran and mixed dietary oils

Timeline

• Start date: 2014-07-01
• Primary completion: 2020-12-05
• Completion: 2020-12-05
• First posted: 2013-09-27
• Last updated: 2022-05-06

Locations

3 sites across 1 country: Canada