Published data in animal models from this group have shown ﬂax seed provides a potent anti-arrhythmic action during ischemia/reperfusion challenge, signiﬁcant anti-atherogenic effects and improves vascular contractile function in atherosclerotic conditions. Supplementing the diets of healthy volunteers with ﬂax seed induces modest reductions in TC and LDL-C and has also been reported to modulate blood glucose levels. Prior to this study, there have been no investigations on the efﬁcacy on primary cardiovascular endpoints in humans. The FLAX-PAD study has been designed to investigate a number of CVD parameters following the long term ingestion of flaxseed.
Flaxseed is an important source of alpha-linolenic acid an essential omega-3 fatty acid. The possibility that a supplementation of the diet with foods rich in alpha-linolenic acid, antioxidants and fiber (like flaxseed) has not been investigated. The primary objective is to determine whether consumption of a diet rich in flaxseed over a one year period has any beneﬁcial cardiovascular effects in patients with Peripheral Arterial Disease (FLAX-PAD study). This is a single center, prospective, double blinded, randomized controlled clinical trial aimed at in 110 patients over 40 years old and with peripheral arterial disease. Patients will receive 30 g of milled ﬂaxseed (or placebo) per day. Primary endpoints are incidence of myocardial infarction and stroke. Secondary measures include: requirement for surgical interventions, exercise and cardiopulmonary performance, cardiac arrhythmias, serum lipid proﬁle, arterial sufﬁciency, blood pressure, inﬂammatory proﬁle, platelet function, changes in drug dosage levels, as well as nutrigenomic and biomarker proﬁles in the blood. Recruitment and baseline examinations started in October 2008. Baseline data of the 110 patients is shown. FLAX-PAD will generate data on the safety, tolerability, cardiovascular efficacy and genomic response to a diet rich in flaxseed. It will determine the effects on primary and secondary events (stroke, myocardial infarctions, angina pectoris, cardiac arrhythmias) as well as in secondary endpoints (exercise performance, blood pressure and circulating lipid levels) in patients with PAD. (Author’s abstract)Link to Full Text