Limits...
Astaxanthin vs placebo on arterial stiffness, oxidative stress and inflammation in renal transplant patients (Xanthin): a randomised controlled trial.

Fassett RG, Healy H, Driver R, Robertson IK, Geraghty DP, Sharman JE, Coombes JS - BMC Nephrol (2008)

Bottom Line: The dietary supplement astaxanthin has shown promise as an antioxidant and anti-inflammatory therapeutic agent in cardiovascular disease.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Renal Research, Royal Brisbane and Women's Hospital, Herston, Brisbane, Queensland, Australia. rfassett@mac.com

ABSTRACT

Background: There 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 design: This 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.

Discussion: The 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 registration: ACTRN12608000159358.

Show MeSH

Related in: MedlinePlus

Flow chart of Xanthin trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC2666668&req=5

Figure 1: Flow chart of Xanthin trial.

Mentions: The Xanthin study flow is summarized in Figure 1 and the study evaluations are outlined in Table 2. After obtaining informed consent patients will be contacted by telephone by the trial coordinator at which a date and time is agreed for subject to attend an appointment for baseline trial measures. A letter of confirmation of this appointment and a Xanthin Trial pathology request form will be posted. Patients will be asked to attend the pathology laboratory at least seven days before their first trial visit to have a fasting blood sample collected. At the first trial visit, additional data will be obtained from the medical records (medical history, medications) and measures of height, weight and blood pressure will be recorded. PWV, PWA, CIMT and BAR measures will then be made. At the completion of baseline data acquisition, the trial coordinator explains and asks the subject to take home two questionnaires (SF 36 and items from Active Australia) and a four-day diet diary for completion. The subject is supplied with a self-addressed express post envelope. Subjects are asked to complete and post these tasks within the following two weeks. Subjects are informed that visit two will be approximately six months after visit one. At the completion of visit one, the clinical trial coordinator will provide patients with a three months supply of trial medication as described in the section on randomization. Subjects will be instructed to take three tablets each day preferably with food. The same instructions are provided on the medication container. Finally, participants are provided with a pathology request form for collection of immunosuppressant levels post one-week initial consumption of trial medication (to assess if there is any change to the plasma immunosuppressive levels). Data obtained at the scheduled study visits and are transcribed onto case record forms for entry into a specifically designed Xanthin trial database. Subjects are contacted by telephone ten weeks after visit one, to ascertain their progress with trial medication adherence. The next three months of trial medications will be supplied to them by post. Subjects are then reminded that they will be contacted by telephone in two months time to confirm an appointment date and time for visit two.


Astaxanthin vs placebo on arterial stiffness, oxidative stress and inflammation in renal transplant patients (Xanthin): a randomised controlled trial.

Fassett RG, Healy H, Driver R, Robertson IK, Geraghty DP, Sharman JE, Coombes JS - BMC Nephrol (2008)

Flow chart of Xanthin trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2666668&req=5

Figure 1: Flow chart of Xanthin trial.
Mentions: The Xanthin study flow is summarized in Figure 1 and the study evaluations are outlined in Table 2. After obtaining informed consent patients will be contacted by telephone by the trial coordinator at which a date and time is agreed for subject to attend an appointment for baseline trial measures. A letter of confirmation of this appointment and a Xanthin Trial pathology request form will be posted. Patients will be asked to attend the pathology laboratory at least seven days before their first trial visit to have a fasting blood sample collected. At the first trial visit, additional data will be obtained from the medical records (medical history, medications) and measures of height, weight and blood pressure will be recorded. PWV, PWA, CIMT and BAR measures will then be made. At the completion of baseline data acquisition, the trial coordinator explains and asks the subject to take home two questionnaires (SF 36 and items from Active Australia) and a four-day diet diary for completion. The subject is supplied with a self-addressed express post envelope. Subjects are asked to complete and post these tasks within the following two weeks. Subjects are informed that visit two will be approximately six months after visit one. At the completion of visit one, the clinical trial coordinator will provide patients with a three months supply of trial medication as described in the section on randomization. Subjects will be instructed to take three tablets each day preferably with food. The same instructions are provided on the medication container. Finally, participants are provided with a pathology request form for collection of immunosuppressant levels post one-week initial consumption of trial medication (to assess if there is any change to the plasma immunosuppressive levels). Data obtained at the scheduled study visits and are transcribed onto case record forms for entry into a specifically designed Xanthin trial database. Subjects are contacted by telephone ten weeks after visit one, to ascertain their progress with trial medication adherence. The next three months of trial medications will be supplied to them by post. Subjects are then reminded that they will be contacted by telephone in two months time to confirm an appointment date and time for visit two.

Bottom Line: The dietary supplement astaxanthin has shown promise as an antioxidant and anti-inflammatory therapeutic agent in cardiovascular disease.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Renal Research, Royal Brisbane and Women's Hospital, Herston, Brisbane, Queensland, Australia. rfassett@mac.com

ABSTRACT

Background: There 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 design: This 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.

Discussion: The 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 registration: ACTRN12608000159358.

Show MeSH
Related in: MedlinePlus