The HYPERFlax trial for determining the anti HYPERtensive effects of dietary flaxseed in newly diagnosed stage 1 hypertensive patients: study protocol for a randomized, double blinded, controlled clinical trial

January 1, 2014 Human Health and Nutrition Data 0 Comments

The HYPERFlax trial for determining the anti HYPERtensive effects of dietary flaxseed in newly diagnosed stage 1 hypertensive patients: study protocol for a randomized, double blinded, controlled clinical trial

Year: 2014
Authors: Caligiuri, S.P. Penner, B. Pierce, G.N.
Publication Name: Trials
Publication Details: Volume 18; Issue 15; Page 232

Abstract:

Background In 2013 the World Health Organization deemed hypertension as a global crisis as it is the leading risk factor attributed to global mortality. Therefore, there is a great need for effective alternative treatment strategies to combat a condition that affects 40 percent of adults worldwide. Recently, the FlaxPAD Trial observed a significant reduction in systolic and diastolic blood pressure in hypertensive patients with peripheral arterial disease that consumed 30 g of milled flaxseed per day for one year. However, these patients were already on anti hypertensive medication. Therefore, there is a need to assess if dietary flaxseed can effectively reduce blood pressure in the absence of peripheral arterial disease and anti-hypertensive medication in newly diagnosed hypertensive patients. Methods Design The HYPERFlax Trial is a parallel, superiority, phase II and III, randomized, double blinded, controlled clinical trial. St. Boniface Hospital and the Health Sciences Centre of Winnipeg, Canada, will recruit 100 participants newly diagnosed with stage 1 hypertension who have yet to be administered anti hypertensive medication. Participants will be randomly allocated with a 1 to 1 ratio into a flaxseed or control group and provided food products to consume daily for six months. At baseline, two, four, and six months, participant assessments will include the primary outcome measure, averaged automated blood pressure, and secondary measures of 24 hour food recall, international physical activity questionnaire, anthropometrics, and blood and urine sampling for biochemical analysis.  Plasma will be assessed for lipids, metabolomics profiling, and molecules that regulate vascular tone. Urine will be collected for metabolomics profiling. With an estimated dropout rate of 20 per cent, the trial will have a power of 0.80 to detect differences between groups and across time, out of an effect size of 0.7 (SD) at an alpha level of 0.05. Discussion This trial will determine if dietary flaxseed is efficacious over six months as an anti hypertensive therapy in subjects newly diagnosed with hypertension. If flaxseed can effectively reduce blood pressure as a monotherapy, then flaxseed will provide individuals on a global basis with a cost effective food based strategy to control hypertension. (Authors abstract)

In 2013 the World Health Organization highlighted that high blood pressure is a global crisis. Hypertension was identified as the number one risk factor attributable to most deaths worldwide and accounted for 16.5 per cent  of deaths. Globally, in 2008, 40 per cent  of adults aged 25 years or older had hypertension.  Flaxseed is one dietary intervention that has been used recently to reduce the risk of cardiovascular disease. Flaxseed has exhibited cardioprotective effects in animal models predisposed to cardiovascular disease by reducing atherogenicity, plasma cholesterol, plasma glucose, plasma trans fats, and blood pressure.  In humans, patients with peripheral arterial disease (75 per cent  hypertensive) were administered 30 g of milled flaxseed per day for six months. Flaxseed consumption resulted in a large decrease in systolic (10 mmHg) and diastolic blood pressure (7 mmHg) that was statistically different from the control group. Blood pressure was inversely associated with plasma concentrations of two flaxseed bioactives, alpha linolenic acid (ALA), and enterolignans. The hypothesis to be tested in the present study is dietary flaxseed will reduce blood pressure in patients with newly diagnosed hypertension and will reduce the need for anti hypertensive medication. In order to test these hypotheses, a phase II, randomized, double blinded, controlled clinical trial called HYPERFlax has been designed.  The acronym for the HYPERFlax trial stands for the anti HYPERtensive effects of dietary Flaxseed. Parameters such as blood pressure, plasma and urine metabolomics, plasma lipid profiling, and plasma vascular tone regulators will be analyzed to assess the efficacy and mechanisms of action of dietary flaxseed in hypertension management. The aims of the HYPERFlax trial are to determine if consuming 30 g of milled flaxseed daily can effectively reduce blood pressure over six months in newly diagnosed stage 1 primary hypertensive participants; determine if dietary flaxseed is efficacious as a monotherapy; determine if flaxseed can reduce the need for antihypertensive medication; and identify the mechanisms of action responsible for the potential anti-hypertensive effects of flaxseed. The HyperFlax trial will be the first study to investigate flaxseed as a therapeutic strategy for the reduction and management of blood pressure in patients newly diagnosed with hypertension who are yet to receive antihypertensive medication. Dietary flaxseed can reduce blood pressure in peripheral arterial disease patients already taking anti hypertensive medication. Therefore, the next logical step is to evaluate flaxseed as a monotherapy rather than in combination with antihypertensive medication, and without the added complication of peripheral arterial disease. The need for therapeutic strategies to reduce the prevalence and incidence of hypertension is necessary. Therefore, this investigation aims to provide essential knowledge on an alternative treatment strategy for hypertension management. (Editors comments)



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