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The effect of a food as medicine intervention to support mental health and wellbeing in autistic adults – A Pilot Randomised Controlled Trial

The effect of a food as medicine intervention to support mental health and wellbeing in autistic adults – A Pilot Randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000728437
Enrollment
25
Registered
2025-07-08
Start date
2025-07-14
Completion date
2026-06-15
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This project aims to examine the feasibility, efficacy, safety and acceptability of a Mediterranean diet intervention for improving mental wellbeing and quality of life in Autistic Adults living in Australia. It utilises a 6-week pilot randomised control trial design with a wait-list control group. While previous trials have shown a positive effect of dietary interventions for improving mental wellbeing in the general public, it is not known if these findings will translate to autistic adults. It is expected that a personalised approach to implementing a Mediterranean diet - which accommodates sensory/personal needs and preferences of autistic adults, will result in high feasibility and acceptability among participants.

Interventions

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 persona

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.

Sponsors

Southern Cross University
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026