Autism Spectrum DisorderNCT06266377
AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder
A study testing Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder and Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder in people with Autism Spectrum Disorder, run by University of Pavia at 3 sites in Italy.
Trial summary
The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference… Read more about this study
- Who is it for?
- Ages 5 to 19 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder and Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Sep 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 5-19 years
- Diagnosis of autism spectrum disorder (grade 1-2 or grade 3)
- Informed consent signed by their caregivers
Who cannot join
- Subjects who are not autonomous in feeding themselves;
- Presence of neurodevelopmental disorders and/or pathological conditions that require the use of special diets;
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Milano Ristorazione S.p.A.
Milan, 20139
Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci".
Roma, 00178
Istituto Tecnico Agrario Statale "Giuseppe Garibaldi"
Roma, 00178
About this study
The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity.
Read the detailed description
The AUT MENU project is a multi-center interventional study conducted on children and adolescents with Autism Spectrum Disorder (ASD) in Milan and Rome.
The main objective of the AUT-MENU project is to improve the meal experience of individuals with Autism Spectrum Disorder (ASD) by developing and disseminating customized menus based on specific dietary recommendations, via collective catering services in schools. The dietary recommendations consider the nutritional and sensory food needs of this population (10.1007/s40519-023-01590-z).
As secondary objective the researchers will evaluate the effect of a nutrition education intervention to the caregivers of the individuals with ASD participating in the study, on reducing their food selectivity. The feasibility of the nutrition education intervention will also be evaluated.
The AUT MENU study deliverable are 1) the development of targeted canteen menus for adults with ASD, according to the nutritional and sensory needs; 2) the elaboration of dietary recommendations to customize canteen menus nutritional and sensory needs for individuals with ASD 3) the development of a nutrition education course aimed at caregivers of a subgroup of the participants.
A total of 16 meal evaluation forms for each participant will be collected on 2 non-consecutive weekly days (for a total of 8 weeks). Both the qualitative and quantitative forms will be filled out by qualified operators, previously trained who assist the participants on a daily basis during lunches eaten at school. For the quantitative evaluation of food consumption, a score will be assigned to the four possible amounts of dish consumed: zero consumption, ¼ of the plate, ½ of the plate, ¾ of the plate, the whole dish.
The nutrition education course aimed at caregivers will be developed in 6 modules. Before and after the course, caregivers will be asked to fill out:
- a questionnaire regarding their children's adherence to the Mediterranean diet
- a validated questionnaire to evaluate their children food selectivity
- a Nutrition Knowledge Questionnaire
- a Satisfaction Questionnaire (of the course)
- Conditions
- Autism Spectrum Disorder
- Being tested
- Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder, Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder
- Keywords
- Food selectivity, Nutrition, Autism spectrum disorder, Collective catering, Food acceptance, mealtime, sustainability
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum DisorderOther
The AUT-MENU intervention study will be structured in two phases: a preliminary observation phase (T0), which will assess and describe the acceptance of standard meals in the context of collective catering in primary and high schools by the subjects enrolled in the study; and an intervention phase (T1) in which the acceptance of menus targeted to the nutritional and sensory needs of the same subjects enrolled at T0 will be assessed.
The revision of the standard menus will be carried 1) balancing energy and macronutrient content, 2) promoting adequate weekly food frequencies consumption and portions, to provide an adequate and sustainable menus 3) adapting the sensory characteristics of the foods offered to the sensory needs of individuals with ASD.
The acceptance of the targeted menus by the enrolled population will be evaluated through meal evaluation forms. These results will be compared with the ones collected during the first observational phase (T0).
Nutrition education course aimed at caregivers of individuals with Autism Spectrum DisorderOther
A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Children afferent to the elementary school where Milano Ristorazione delivers meals and adolescents and young adults enrolled in the State Agricultural Technical Institute Giuseppe Garibaldi (Rome) and Institute I.P.S.E.O.A. "Tor Carbone - A. Narducci." Receives: Other: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder; Other: Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food acceptance of canteen menus by individuals enrolled in the study
Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)
Measured: 8 weeks (T0); 8 weeks (T1)
Secondary outcomes (1)
Reduction in food selectivity as a result of the targeted nutrition education course
Caregivers of a subgroup of the enrolled subjects will undergo a nutrition education course adapted to the needs of individuals with autism spectrum disorder. Caregivers will be asked to fill out questionnaires assessing food selectivity and adherence to the Mediterranean diet before and after the intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized multi-center intervention with a single arm. Study participants will receive new adapted canteen menus according to the nutritional and sensory needs of the target population.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA)
- Responsible party
- Sponsor
- Investigators
- Hellas Cena, MD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266377
- Sponsor's protocol ID
- 11122023
- Status last verified
- Dec 2023
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conti MV, Breda C, Basilico S, Luzzi A, Voto L, Santero S, De Filippo G, Cena H. Dietary recommendations to customize canteen menus according to the nutritional and sensory needs of individuals with autism spectrum disorder. Eat Weight Disord. 2023 Aug 1;28(1):66. doi: 10.1007/s40519-023-01590-z.
PubMed 37526770Conti MV, Breda C, Basilico S, Zambon I, Sofroniou A, Ruggeri S, Scalvedi ML, Cena H. Improving Meal Acceptance of Individuals With Autism Spectrum Disorder (AUT-MENU Project): Protocol for a Bicentric Intervention Study. JMIR Res Protoc. 2025 May 21;14:e57507. doi: 10.2196/57507.
PubMed 40397941
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06266377
- Acronym / sponsor ID
- 11122023
- Conditions
- Autism Spectrum Disorder
- Keywords
- Food selectivity, Nutrition, Autism spectrum disorder, Collective catering, Food acceptance, mealtime, sustainability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA)
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity.
Detailed description
The AUT MENU project is a multi-center interventional study conducted on children and adolescents with Autism Spectrum Disorder (ASD) in Milan and Rome.
The main objective of the AUT-MENU project is to improve the meal experience of individuals with Autism Spectrum Disorder (ASD) by developing and disseminating customized menus based on specific dietary recommendations, via collective catering services in schools. The dietary recommendations consider the nutritional and sensory food needs of this population (10.1007/s40519-023-01590-z).
As secondary objective the researchers will evaluate the effect of a nutrition education intervention to the caregivers of the individuals with ASD participating in the study, on reducing their food selectivity. The feasibility of the nutrition education intervention will also be evaluated.
The AUT MENU study deliverable are 1) the development of targeted canteen menus for adults with ASD, according to the nutritional and sensory needs; 2) the elaboration of dietary recommendations to customize canteen menus nutritional and sensory needs for individuals with ASD 3) the development of a nutrition education course aimed at caregivers of a subgroup of the participants.
A total of 16 meal evaluation forms for each participant will be collected on 2 non-consecutive weekly days (for a total of 8 weeks). Both the qualitative and quantitative forms will be filled out by qualified operators, previously trained who assist the participants on a daily basis during lunches eaten at school. For the quantitative evaluation of food consumption, a score will be assigned to the four possible amounts of dish consumed: zero consumption, ¼ of the plate, ½ of the plate, ¾ of the plate, the whole dish.
The nutrition education course aimed at caregivers will be developed in 6 modules. Before and after the course, caregivers will be asked to fill out:
- a questionnaire regarding their children's adherence to the Mediterranean diet
- a validated questionnaire to evaluate their children food selectivity
- a Nutrition Knowledge Questionnaire
- a Satisfaction Questionnaire (of the course)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized multi-center intervention with a single arm. Study participants will receive new adapted canteen menus according to the nutritional and sensory needs of the target population.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder, Other: Nutrition education course aimed at caregivers of individuals with Autism Spectrum DisorderChildren afferent to the elementary school where Milano Ristorazione delivers meals and adolescents and young adults enrolled in the State Agricultural Technical Institute Giuseppe Garibaldi (Rome) and Institute I.P.S.E.O.A. "Tor Carbone - A. Narducci." |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 5-19 years
- Diagnosis of autism spectrum disorder (grade 1-2 or grade 3)
- Informed consent signed by their caregivers
Key exclusion criteria (2 listed)
- Subjects who are not autonomous in feeding themselves;
- Presence of neurodevelopmental disorders and/or pathological conditions that require the use of special diets;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum DisorderThe AUT-MENU intervention study will be structured in two phases: a preliminary observation phase (T0), which will assess and describe the acceptance of standard meals in the context of collective catering in primary and high schools by the subjects enrolled in the study; and an intervention phase (T1) in which the acceptance of menus targeted to the nutritional and sensory needs of the same subjects enrolled at T0 will be assessed. The revision of the standard menus will be carried 1) balancing energy and macronutrient content, 2) promoting adequate weekly food frequencies consumption and portions, to provide an adequate and sustainable menus 3) adapting the sensory characteristics of the foods offered to the sensory needs of individuals with ASD. The acceptance of the targeted menus by the enrolled population will be evaluated through meal evaluation forms. These results will be compared with the ones collected during the first observational phase (T0). | Other | Intervention group |
| Nutrition education course aimed at caregivers of individuals with Autism Spectrum DisorderA population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity. | Other | Intervention group |
Primary outcome
Food acceptance of canteen menus by individuals enrolled in the study
Time frame: 8 weeks (T0); 8 weeks (T1)
Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)
1 secondary outcome
Reduction in food selectivity as a result of the targeted nutrition education course
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 37526770Conti MV, Breda C, Basilico S, Luzzi A, Voto L, Santero S, De Filippo G, Cena H. Dietary recommendations to customize canteen menus according to the nutritional and sensory needs of individuals with autism spectrum disorder. Eat Weight Disord. 2023 Aug 1;28(1):66. doi: 10.1007/s40519-023-01590-z.
- Derived from this study: PubMed 40397941Conti MV, Breda C, Basilico S, Zambon I, Sofroniou A, Ruggeri S, Scalvedi ML, Cena H. Improving Meal Acceptance of Individuals With Autism Spectrum Disorder (AUT-MENU Project): Protocol for a Bicentric Intervention Study. JMIR Res Protoc. 2025 May 21;14:e57507. doi: 10.2196/57507.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hellas Cena, MD principal investigator
University of Pavia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder and Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder in people with Autism Spectrum Disorder, run by University of Pavia at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Vittoria Conti, BSc (0382987536, mariavittoria.conti@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food acceptance of canteen menus by individuals enrolled in the study (time frame: 8 weeks (T0); 8 weeks (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266377, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.