Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000728437p
Ethics application status
Submitted, not yet approved
Date submitted
15/04/2025
Date registered
8/07/2025
Date last updated
8/07/2025
Date data sharing statement initially provided
8/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a food as medicine intervention to support mental health and wellbeing in autistic adults – A Pilot Randomised Controlled Trial
Scientific title
The effect of a food as medicine intervention to support mental health and wellbeing in autistic adults – A Pilot Randomised Controlled Trial
Secondary ID [1] 314219 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 337122 0
Condition category
Condition code
Mental Health 333542 333542 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is a personalised Mediterranean Diet. This follows the standard guidelines and recommendations for the Mediteranean diet (A diet abundant in plant foods such as fruits, vegetables, whole grains, nuts, seeds and legumes. The principal source of dietary lipids is in the form of olive oil. It is low in processed foods and red meat. Dairy is consumed in low to moderate amounts and no more than 4 eggs are consumed per week). Diet suggestions and recommendations will be personalised to each participant to accommodate their sensory/personal needs and food preferences (For example, the participant may have food preferences regarding texture, colour, smell etc). The intervention will be delivered one-on-one with a qualified nutritionist, and will be delivered weekly with 1 hour telehealth appointments (online). Utilising a 6-week pilot randomised control trial design with a wait-list control group. Adherence to the dietary recommendation will be monitored with the MedQ-Sus (collected online fortnightly) as well as at weekly appointments with the nutritionist.
Intervention code [1] 330830 0
Treatment: Other
Comparator / control treatment
There is a wait-list control for this study. The participants allocated to this group will commence the 6 week diet intervention after the 6 week wait period
Control group
Active

Outcomes
Primary outcome [1] 341122 0
Feasibility (composite outcome)
Timepoint [1] 341122 0
Feasibility will be monitored through out the trial, However, recruitment feasibility will be assessed at the conclusion of the trial, once the target number has been reached. The Intervention feasibility and acceptability will be assessed at week 6, with resource allocation and challenges formally assessed at the trial conclusion.
Secondary outcome [1] 446362 0
Acceptability
Timepoint [1] 446362 0
Acceptability questions/surveys will be administered in week 2, 4 and 6
Secondary outcome [2] 446760 0
Quality of life
Timepoint [2] 446760 0
Measured at week 2, 4 and 6 of the intervention
Secondary outcome [3] 446363 0
Safety
Timepoint [3] 446363 0
Safety questions designed specifically for this study will be administered in Week 2, 4 and 6, adverse events logged and recorded as they occur on the adverse events log
Secondary outcome [4] 446758 0
Depression
Timepoint [4] 446758 0
Measured at week 2, 4 and 6 of the intervention
Secondary outcome [5] 446759 0
The degree to which individuals find unpredictable and negative events unacceptable
Timepoint [5] 446759 0
Measured at week 2, 4 and 6 of the intervention
Secondary outcome [6] 449439 0
Safety Parameters (composite secondary outcome): Monitoring for changes in clinical indicators that could suggest harm. Short-term safety of the dietary intervention in terms of physical health (e.g., any digestive or allergic reactions). Psychological safety to ensure the intervention doesn't cause negative effects on mental well-being (e.g., anxiety, irritability). - Overall health changes or no change (ensuring no negative impact on participants' physical or mental health).
Timepoint [6] 449439 0
week, 2, 4 and 6 of the intervention
Secondary outcome [7] 446364 0
Anxiety
Timepoint [7] 446364 0
Measured in week 2, 4 and 6 of the intervention

Eligibility
Key inclusion criteria
- Autism diagnosis or self-diagnosis
- Scored 9 or less on the MedQ-Sus
- Scored 10 or above on the PHQ 9
- Adults over 18 years of age
- Residing in Australia
- Access to the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Those unable to understand English
- Individuals not capable of understanding or consenting what is involved with this trial
- Individuals who are also diagnosed with any of the following mental health disorders: bipolar disorder, post-traumatic stress, personality disorders, eating disorders, psychotic disorders such as schizophrenia or a substance abuse disorder such as alcoholism.
- Individuals who are also diagnosed with gastrointestinal disorders such as Crohn's disease, ulcerative colitis, irritable bowel syndrome etc.
- Individuals with eating disorders
- Individuals who are unavailable to attend the scheduled appointments.
- Individuals who are unwilling to change their diet
- If the PHQ 9 indicates suicidal thoughts or ideations

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
15/06/2026
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318736 0
Charities/Societies/Foundations
Name [1] 318736 0
The Jacka Foundation
Country [1] 318736 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Country
Australia
Secondary sponsor category [1] 321172 0
Charities/Societies/Foundations
Name [1] 321172 0
The Jacka Foundation
Address [1] 321172 0
Country [1] 321172 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317349 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 317349 0
Ethics committee country [1] 317349 0
Australia
Date submitted for ethics approval [1] 317349 0
06/05/2025
Approval date [1] 317349 0
Ethics approval number [1] 317349 0

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

Contacts
Principal investigator
Name 140762 0
Dr Jessica Bayes
Address 140762 0
SCU, Military Rd, East Lismore, NSW, 2480
Country 140762 0
Australia
Phone 140762 0
+61 401962947
Fax 140762 0
Email 140762 0
[email protected]
Contact person for public queries
Name 140763 0
Jessica Bayes
Address 140763 0
SCU, Military Rd, East Lismore, NSW, 2480
Country 140763 0
Australia
Phone 140763 0
+61 401962947
Fax 140763 0
Email 140763 0
[email protected]
Contact person for scientific queries
Name 140764 0
Jessica Bayes
Address 140764 0
SCU, Military Rd, East Lismore, NSW, 2480
Country 140764 0
Australia
Phone 140764 0
+61 401962947
Fax 140764 0
Email 140764 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.