None listed
Conditions
Brief summary
The study is a randomised controlled trial investigating the effect of 6 weeks of immuno-nutrition supplementation on post-procedure vascular complications and hospital length of stay in patients with peripheral arterial disease scheduled for revascularisation procedure. It is hypothesized that supplementation with an immuno-nutrient containing supplement will lead to improved clinical outcomes in patients with peripheral arterial disease through the attenuation of the inflammatory process component of atherosclerosis. Intervention participants will receive individualised supplementation for 2 weeks prior to the revascularisation procedure and 4-weeks post -procedure under the direction of an Accredited Practicing Dietitian. Control participants will receive usual clinical care where no immune-nutrition supplementation is provided. All participants will be followed up at 1-, 3-, 6- and 12-months post-procedure as apart of usual clinical care.
Interventions
- Ensure Plus Strength, a pre-packaged oral liquid supplement will be administered for 6 weeks.
- Dosage will be individualised based on food frequency questionnaire and assessment of dietary intake of immune-modulating nutrients, in particular vitamins and minerals by an Accredited Practising Dietitian. The target is to achieve the Recommended Daily Intake (RDI) or Adequate Intake (AI) as per the Australian and New Zealand Nutrient Reference Values (NRVs). The dosage will be 1 or 2 x 220ml b
- Ensure Plus Strength, a pre-packaged oral liquid supplement will be administered for 6 weeks. - Dosage will be individualised based on food frequency questionnaire and assessment of dietary intake of immune-modulating nutrients, in particular vitamins and minerals by an Accredited Practising Dietitian. The target is to achieve the Recommended Daily Intake (RDI) or Adequate Intake (AI) as per the Australian and New Zealand Nutrient Reference Values (NRVs). The dosage will be 1 or 2 x 220ml bottles of the supplement each day. - Adherence to the intervention will be monitored using a participant diary to record the prescribed amount of supplement and the amount actually consumed. The diary will also be used to monitor for any side effects.
Sponsors
Abbott Medical Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inpatients and outpatients at Flinders Medical Centre who are scheduled to undergo open or endovascular revascularisation for PAD.
Exclusion criteria
Patients will be excluded if they are: 1) <18 years old; 2) have been diagnosed with a terminal illness; 3) are unable to communicate effectively to provide informed consent such as those with cognitive impairment; 4) have a diagnosis of galactosemia (a contra-indication to immuno-nutrition supplement) or 5) have a fluid restriction.
Outcome results
None listed