Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000635460p
Ethics application status
Submitted, not yet approved
Date submitted
26/05/2025
Date registered
17/06/2025
Date last updated
17/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Bites Huntington's Disease: A Mediterranean meal box for families
Scientific title
Brain Bites HD: Feasibility and preliminary effects of a Mediterranean meal box for Huntington’s disease families.
Secondary ID [1] 314528 0
Not applicable
Universal Trial Number (UTN)
U1111-1323-3234
Trial acronym
Brain Bites HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 337629 0
Condition category
Condition code
Neurological 333956 333956 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Mediterranean meal box intervention will be provided over one-week to individuals with symptomatic Huntington’s disease. Meal boxes will be delivered on a Sunday by a commercial provider operating in Victoria and New South Wales. Each box will contain ingredients and recipes to prepare four main meals as well as kitchen safety tips and cooking strategies tailored to the needs of people living with Huntington’s disease. Participants will be asked to prepare the four meals during the working week using the provided ingredients and recipes. Throughout the intervention, participants will be asked to take photos of their ingredient set-up before cooking, the meal produced, the mess created during the cook and post eating and any food that was not eaten. They will also be asked to rate the difficulty of cooking and taste of the meal and provide any additional feedback they wish.

Examples of Meals and Ingredients
Participants will be presented with Mediterranean-style meals such as (only examples):

Grilled salmon with quinoa salad and roasted vegetables

Chickpea and vegetable stew with wholegrain bread

Chicken and lentil tagine with seasonal greens

Greek-style salad with feta and olives served alongside a vegetable omelette

Key ingredients include olive oil, fresh vegetables (capsicum, tomato, leafy greens), legumes (chickpeas, lentils), wholegrains (quinoa, brown rice), lean meats or fish, fresh herbs and citrus.

Anticipated Preparation and Cooking Time
Each meal is expected to take less than 30 minutes to prepare and cook, ensuring they are practical and accessible for people living with Parkinson’s disease and their families.

Batch Cooking
The meals provided in the meal box will not be batch-cooked. Instead, they will be designed for fresh preparation each day using pre-portioned ingredients. This approach supports flexibility in meal preparation and helps maintain food safety standards.

Advice for Remaining Main Meals
Participants will not receive specific guidance for the remaining meals outside of the provided meal box recipes. They will be able to choose what to cook or eat for their other main meals, whether that involves preparing different meals at home or eating out.

Preparation of Kitchen Safety Tips and Cooking Strategies
Kitchen safety tips and cooking strategies for the meal box will be developed by the occupational therapist on the research team. These resources will be tailored to the needs of people living with Parkinson’s disease, ensuring a safe and supportive cooking experience.
Intervention code [1] 331162 0
Lifestyle
Comparator / control treatment
No comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341608 0
Feasibility
Timepoint [1] 341608 0
Feasibility will be examined throughout the duration of the study. Participant recruitment rates will be determined at the end of the study/following recruitment of the final eligible participant. Adverse events will be calculated following the completion 0f the intervention period and semi-structured interview. Interviews will be completed within two weeks of completing the intervention period.
Secondary outcome [1] 448064 0
Cooking and eating behaviours evaluation
Timepoint [1] 448064 0
Cooking and eating behaviours will be evaluated before and after the intervention period utilising a semi-structured interview.
Secondary outcome [2] 448065 0
Quality of life
Timepoint [2] 448065 0
Quality of life will be evaluated before and after the intervention period with the EQ-5D-L.

Eligibility
Key inclusion criteria
Forty HD families will be identified through existing research databases, Huntington's Australia and local clinicians and will be screened for study eligibility. Families will be required to have at least one member of the household with a neurologist-confirmed diagnosis of HD and experiencing symptoms of the disease. The person living with HD must be prepared and have the physical and cognitive capacity (clinician supported) to undertake cooking independently or with support throughout the duration of the intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include lack of access to functional food storage and cooking facilities within the home, the requirement for texture-modified foods due to later-stage HD and restrictive food allergies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data analyses will be conducted using R software (version 4.3.0, 2023). Data normality will be assessed using the Shapiro–Wilks test, and parametric or nonparametric methods will be applied accordingly. Descriptive statistics, including percentages, means, and ranges, will summarise process, resource, and management feasibility outcomes. Safety, tolerability, and compliance measures will be evaluated throughout the study. Thematic analysis will be used to analyse data captured from semi-structured interviews.
Patient-reported QoL data will be analysed using the Friedman test. Significant differences will be further examined with post hoc pairwise comparisons using the Wilcoxon signed-rank test, with adjustments for multiple comparisons. Statistical significance will be set at p < .05. Qualitative data from semi-structured interviews will be analysed using thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/08/2025
Actual
Date of last participant enrolment
Anticipated
27/10/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 319079 0
Charities/Societies/Foundations
Name [1] 319079 0
Perpetual Limited
Country [1] 319079 0
Australia
Primary sponsor type
University
Name
Centre for Precision Health (Edith Cowan University)
Address
Country
Australia
Secondary sponsor category [1] 321541 0
None
Name [1] 321541 0
None
Address [1] 321541 0
Country [1] 321541 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317676 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 317676 0
Ethics committee country [1] 317676 0
Australia
Date submitted for ethics approval [1] 317676 0
23/05/2025
Approval date [1] 317676 0
Ethics approval number [1] 317676 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141782 0
Dr Travis Cruickshank
Address 141782 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 141782 0
Australia
Phone 141782 0
+61 08 6304 3416
Fax 141782 0
Email 141782 0
[email protected]
Contact person for public queries
Name 141783 0
Travis Cruickshank
Address 141783 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 141783 0
Australia
Phone 141783 0
+61 08 6304 3416
Fax 141783 0
Email 141783 0
[email protected]
Contact person for scientific queries
Name 141784 0
Travis Cruickshank
Address 141784 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia
Country 141784 0
Australia
Phone 141784 0
+61 08 6304 3416
Fax 141784 0
Email 141784 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The research is informing the development of a commercial product.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.