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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000207819
Acronym
Nutrition in A-T
Enrollment
20
Registered
2012-02-20
Start date
2012-03-21
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 requiremen

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.

Sponsors

Royal Brisbane & Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Ataxia-telangiectasia diagnosis and attending the National Ataxia Clinic at Royal Brisbane Hospital

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026