Autism Spectrum DisorderNCT05978895
FOOD-AUT Pilot Study Canteen Menus for Adults With Autism Spectrum Disorder
A study testing Targeted canteen menus in people with Autism Spectrum Disorder, run by University of Pavia at 1 site in Italy.
Trial summary
The FOOD-AUT pilot study aimed to improve the health status of adults with Autism Spectrum Disorder (ASD) through a nutritional intervention at canteen service. The researchers adapted the canteen menus to the nutritional and sensory needs of this vulnerable population, reducing their food selectivity and improving… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Targeted canteen menus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2022to 30 Mar 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Diagnosis of autism spectrum disorder (grade 1-2 or grade 3)
- Admission to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy)
- Informed consent signed by their caregivers
Who cannot join
- Age < 18 years old
- Not diagnosed with autism spectrum disorder (grade 1-2 or grade 3)
- Not admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy)
- Informed consent not signed by their caregivers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FOOD-AUT Pilot Study Developing Canteen Menus Targeted to Nutritional and Sensory Needs of Adults With Autism Spectrum Disorder
The FOOD-AUT pilot study aimed to improve the health status of adults with Autism Spectrum Disorder (ASD) through a nutritional intervention at canteen service. The researchers adapted the canteen menus to the nutritional and sensory needs of this vulnerable population, reducing their food selectivity and improving their dietary diversity with a positive impact on their health.
This project consisted of two phases: first an observational phase (Work Package 1, WP1) and secondarily an interventional phase (Work Package 2, WP2).
Read the detailed description
The FOOD-AUT project was a pilot study conducted at the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) on adults with Autism Spectrum Disorder (ASD). The project lasted 12 months.
The main objective of the FOOD-AUT pilot study was to positively impact on the health condition of adults with ASD, improving food acceptability and increasing dietary diversity through the development of canteen service menus adapted to their nutritional and sensory needs.
The main outcome was the improvement of food acceptance of the canteen menus by the adults with ASD.
The FOOD-AUT pilot study deliverable were 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.
Participants of this study were adults (≥ 18 years old) diagnosed with an autism spectrum disorder (grade 1-2 or 3), admitted to the day care center for disabled persons (CDD) at Sacra Famiglia Fondazione Onlus (Cesano Boscone, Milan, Italy).
Based on the results of WP1, new canteen menus were drafted by qualified dietitians according to the nutritional and sensory needs of the targeted population. The new formulated menus 1) provided adequate caloric and macronutrient content, and 2) proposed with greater frequency foods having more accepted textures, colors, smells and temperatures.
A total of 12 meal evaluation forms for each participant were collected on 3 non-consecutive weekly days (for a total of 4 weeks). Both the qualitative and quantitative forms were filled out by qualified operators, previously trained, of the Sacra Famiglia Onlus Foundation, who assist the participants on a daily basis during lunches eaten at the facility. For the quantitative evaluation of food consumption, a score was 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Targeted canteen menus
- Keywords
- autism spectrum disorder, canteen menus, nutrition, food acceptance, sensory, color, texture, smell, sustainability, mealtime
- Medical subject headings
- Autism Spectrum Disorder, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted canteen menusOther
The nutritional intervention consisted in the development of targeted menus aiming at the needs of individuals with ASD and in assessing their acceptance of the targeted menus.
The revision of the standard menus was carried 1) balancing energy and macronutrient content, according to LARN 2014; 2) promoting adequate weekly food frequencies consumption and portions, to provide an adequate and sustainable menus according to CREA 2018; 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 was evaluated through meal evaluation forms. These results were compared with the ones collected during the first observational phase (WP1). In fact, referring to the results of WP1, new canteen menus were drafted according to the nutritional and sensory needs of the population.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 22 adults with autism spectrum disorder (grade 1-2 or 3), admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) Receives: Other: Targeted canteen menus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food acceptance of canteen menus by adults with Autism Spectrum Disorder
Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)
Measured: 4 weeks (WP1); 4 weeks (WP2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start30 Mar 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
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 intervention with a single arm. Study participants received new adapted canteen menus according to the nutritional and sensory needs of the target population.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hellas Cena, MD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978895
- Sponsor's protocol ID
- 30062023
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 21 Sep 2023
- Results posted
- 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, Santero S, Breda C, Basilico S, de Filippo G, Luzzi A, Voto L, Cavagnola R, Tomasinelli CE, Cena H. Autism Spectrum Disorder and collective catering service: results of the pilot study FOOD-AUT. Front Nutr. 2024 Jan 10;10:1298469. doi: 10.3389/fnut.2023.1298469. eCollection 2023.
PubMed 38268678
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOOD-AUT Pilot Study Developing Canteen Menus Targeted to Nutritional and Sensory Needs of Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05978895
- Acronym / sponsor ID
- 30062023
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, canteen menus, nutrition, food acceptance, sensory, color, texture, smell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 7 Aug 2023 (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 FOOD-AUT pilot study aimed to improve the health status of adults with Autism Spectrum Disorder (ASD) through a nutritional intervention at canteen service. The researchers adapted the canteen menus to the nutritional and sensory needs of this vulnerable population, reducing their food selectivity and improving their dietary diversity with a positive impact on their health.
This project consisted of two phases: first an observational phase (Work Package 1, WP1) and secondarily an interventional phase (Work Package 2, WP2).
Detailed description
The FOOD-AUT project was a pilot study conducted at the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) on adults with Autism Spectrum Disorder (ASD). The project lasted 12 months.
The main objective of the FOOD-AUT pilot study was to positively impact on the health condition of adults with ASD, improving food acceptability and increasing dietary diversity through the development of canteen service menus adapted to their nutritional and sensory needs.
The main outcome was the improvement of food acceptance of the canteen menus by the adults with ASD.
The FOOD-AUT pilot study deliverable were 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.
Participants of this study were adults (≥ 18 years old) diagnosed with an autism spectrum disorder (grade 1-2 or 3), admitted to the day care center for disabled persons (CDD) at Sacra Famiglia Fondazione Onlus (Cesano Boscone, Milan, Italy).
Based on the results of WP1, new canteen menus were drafted by qualified dietitians according to the nutritional and sensory needs of the targeted population. The new formulated menus 1) provided adequate caloric and macronutrient content, and 2) proposed with greater frequency foods having more accepted textures, colors, smells and temperatures.
A total of 12 meal evaluation forms for each participant were collected on 3 non-consecutive weekly days (for a total of 4 weeks). Both the qualitative and quantitative forms were filled out by qualified operators, previously trained, of the Sacra Famiglia Onlus Foundation, who assist the participants on a daily basis during lunches eaten at the facility. For the quantitative evaluation of food consumption, a score was 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.
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 intervention with a single arm. Study participants received new adapted canteen menus according to the nutritional and sensory needs of the target population.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Targeted canteen menus22 adults with autism spectrum disorder (grade 1-2 or 3), admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Diagnosis of autism spectrum disorder (grade 1-2 or grade 3)
- Admission to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy)
- Informed consent signed by their caregivers
Key exclusion criteria (4 listed)
- Age < 18 years old
- Not diagnosed with autism spectrum disorder (grade 1-2 or grade 3)
- Not admitted to the daycare service of Sacra Famiglia Onlus Foundation in Cesano Boscone (Milan, Italy)
- Informed consent not signed by their caregivers
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 |
|---|---|---|
| Targeted canteen menusThe nutritional intervention consisted in the development of targeted menus aiming at the needs of individuals with ASD and in assessing their acceptance of the targeted menus. The revision of the standard menus was carried 1) balancing energy and macronutrient content, according to LARN 2014; 2) promoting adequate weekly food frequencies consumption and portions, to provide an adequate and sustainable menus according to CREA 2018; 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 was evaluated through meal evaluation forms. These results were compared with the ones collected during the first observational phase (WP1). In fact, referring to the results of WP1, new canteen menus were drafted according to the nutritional and sensory needs of the population. | Other | Intervention group |
Primary outcome
Food acceptance of canteen menus by adults with Autism Spectrum Disorder
Time frame: 4 weeks (WP1); 4 weeks (WP2)
Meal evaluation forms (score range for each item: 0-1; the score number is directly proportional to the amount of the dish consumed)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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 38268678Conti MV, Santero S, Breda C, Basilico S, de Filippo G, Luzzi A, Voto L, Cavagnola R, Tomasinelli CE, Cena H. Autism Spectrum Disorder and collective catering service: results of the pilot study FOOD-AUT. Front Nutr. 2024 Jan 10;10:1298469. doi: 10.3389/fnut.2023.1298469. eCollection 2023.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted canteen menus in people with Autism Spectrum Disorder, run by University of Pavia at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food acceptance of canteen menus by adults with Autism Spectrum Disorder (time frame: 4 weeks (WP1); 4 weeks (WP2)). 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 NCT05978895, 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 21 Sep 2023.