Abstract
BackgroundThere is evidence that renal transplant recipients have accelerated atherosclerosis manifest by increased cardiovascular morbidity and mortality. The high incidence of atherosclerosis is, in part, related to increased arterial stiffness, vascular dysfunction, elevated oxidative stress and inflammation associated with immunosuppressive therapy. The dietary supplement astaxanthin has shown promise as an antioxidant and anti-inflammatory therapeutic agent in cardiovascular disease. The aim of this trial is to investigate the effects of astaxanthin supplementation on arterial stiffness, oxidative stress and inflammation in renal transplant patients.Method and DesignThis is a randomised, placebo controlled clinical trial. A total of 66 renal transplant recipients will be enrolled and allocated to receive either 12 mg/day of astaxanthin or an identical placebo for one-year. Patients will be stratified into four groups according to the type of immunosuppressant therapy they receive: 1) cyclosporine, 2) sirolimus, 3) tacrolimus or 4) prednisolone+/-azathioprine, mycophenolate mofetil or mycophenolate sodium. Primary outcome measures will be changes in 1) arterial stiffness measured by aortic pulse wave velocity (PWV), 2) oxidative stress assessed by plasma isoprostanes and 3) inflammation by plasma pentraxin 3. Secondary outcomes will include changes in vascular function assessed using the brachial artery reactivity (BAR) technique, carotid artery intimal medial thickness (CIMT), augmentation index (AIx), left ventricular afterload and additional measures of oxidative stress and inflammation. Patients will undergo these measures at baseline, six and 12 months.DiscussionThe results of this study will help determine the efficacy of astaxanthin on vascular structure, oxidative stress and inflammation in renal transplant patients. This may lead to a larger intervention trial assessing cardiovascular morbidity and mortality.Trial RegistrationACTRN12608000159358
Highlights
There is evidence that renal transplant recipients have accelerated atherosclerosis manifest by increased cardiovascular morbidity and mortality
Numerous studies have reported elevated levels of oxidative stress and inflammation in this population [3,4,5,6,7] and this has been associated with arterial stiffness [8]
Our research group has shown that cyclosporine, a commonly used immunosuppressant taken by renal transplant recipients, increases markers of oxidative stress [9,10] and decreases vascular function [11]
Summary
Vascular disease is the leading cause of morbidity and mortality in renal transplant recipients [1]. Measures of blood pressure and blood chemistry conducted at four and eight weeks, revealed no significant differences between the treatment and placebo group and the authors concluded that 6 mg of astaxanthin per day from a Haematococcus pluvialis algal extract can be safely consumed by healthy adults. At this stage, little is known regarding the effectiveness of antioxidant supplementation on vascular disease in renal transplant patients. The purpose of this study is to assess the effect of antioxidant supplementation with astaxanthin on arterial stiffness, oxidative stress and inflammation in renal transplant patients
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