RecruitingACTRN12612000207819

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

Sponsor

Royal Brisbane & Women's Hospital

Enrollment

20 participants

Start Date

Mar 21, 2012

Study Type

Interventional

Conditions

Ataxia-telangiectasia

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

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is testing two types of dietary support for patients with Ataxia-Telangiectasia (A-T), a rare genetic condition that affects movement, coordination, and the immune system. Researchers will test whether standard nutritional advice and supplements, or an antioxidant-rich whole food therapy, can reduce the effects of oxidative stress and improve health outcomes in people with A-T. This study is open to patients attending the National Ataxia Clinic at the Royal Brisbane Hospital. You may be eligible if: - You have been diagnosed with Ataxia-Telangiectasia - You attend the National Ataxia Clinic at Royal Brisbane Hospital You may NOT be eligible if: - You do not have adequate support at home to follow specific dietary advice - You receive most or all of your nutrition through a feeding tube (PEG) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Australia

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ACTRN12612000207819