Therapeutic Approaches to Nutrition in Ataxia-Telangiectasia: a Randomised Controlled Matched Cross-over Trial
A randomised controlled age-matched cross-over trial design in individuals diagnosed with Ataxia-telangiectasia to examine the efficacy of standard and therapeutic nutritional interventions to reduce inflammation and neurodegeneration
Royal Brisbane & Women's Hospital
20 participants
Mar 21, 2012
Interventional
Conditions
Summary
1. The overall aim is to provide nutritional intervention as part of the multi-disciplinary management of A-T patients attending the national clinic. 2. To evaluate the effectiveness of standard nutritional advice and standardised supplements for improving intakes and outcomes in A-T. 3. To implement a randomised controlled age-matched cross-over trial design to evaluate the efficacy of a conjunctive anti-oxidant therapy using whole food ingredients to limit or reduce oxidative stress and improve outcomes in A-T.
Eligibility
Inclusion Criteria1
- Ataxia-telangiectasia diagnosis and attending the National Ataxia Clinic at Royal Brisbane Hospital
Exclusion Criteria2
- those without support at home to enable them to follow specific dietary advice;
- those who are recieving most or all of their nutrition via PEG
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Interventions
Participants will be matched for age and randomised to Group A and Group B. All will be required to follow advice from the same dietitian during 2 x 12-week treatment periods: Treatment period 1 - Group A will receive i) standard nutritional advice (to meet individual energy/protein and recommended nutrient requirements including standard vitamin and mineral supplement) and Group B will receive ii) standard nutritional advice (to meet individual energy/protein and recommended nutrient requirements including standard vitamin and mineral supplement) PLUS therapeutic antioxidant-rich food-based advice (individuals provided with food-based ingredients and instructions for making into an anti-oxidant-rich drink). This will be followed by a 4-week washout period. Groups will then cross-over treatments. Treatment period 2 - Group A will receive ii) standard nutritional advice PLUS therapeutic antioxidant-rich food-based advice and Group A will receive i) standard nutritional advice. All participants will receive an initial 1 hour one-on-one session with the dietitian followed by weekly telephone calls from the dietitian allowing a half hour to answer questions and provide support.
Locations(1)
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ACTRN12612000207819