Impact of Nutritional Counselling in Children With Autism

• ClinicalTrials.gov Identifier: NCT04652388
• Recruitment Status: Unknown
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Sponsor: Federico II University
• Information provided by (Responsible Party): Roberto Berni Canani, Federico II University

Study Description

Brief Summary:

Autism Spectrum Disorder (ASD) is a complex group of behavioral disorders characterized by defects in social interaction and communication associated with restricted and repetitive behaviors and activities. The prevalence in pediatric age is continuously increasing in Western countries (58-67 / 10,000). The Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) describes a worldwide population prevalence of approximately 1%. According to the latest data from the National Observatory for the monitoring of ASD, in Italy 1 child out of 77 (age 7-9 years) has the disease with a higher prevalence in males: males are affected 4.4 times more than females . The clinical manifestations of ASD are the result of complex interactions between genetic, epigenetic, environmental and microbiological factors. Alterations in nutritional status, eating habits and adverse reactions to food appear to be more frequent in children with ASD. It is estimated that 46-89% of children with ASD have feeding problems which can include unusual eating patterns, rituals and food selectivity. These types of eating behaviors can lead to severe alterations in nutritional status. Furthermore, the data present in the literature concerning the eating habits of children with ASD suggest a high consumption of "junk food" and foods rich in calories together with a refusal of fruit, vegetables or proteins. These data suggest that the dietary and behavioral problems frequently present in these children could favor a condition of obesity. Finally, a high percentage of children with ASD undergo elimination diets, characterized by exclusions of foods relevant to the diet of a child such as milk and gluten to alleviate the symptoms of the disease. Such elimination diets are only rarely supervised by a nutritionist with further consequences on nutritional status.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Behavioral: Nutritional counseling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Impact of Nutritional Counselling in Children With Autistic Spectrum Disorder
• Actual Study Start Date: September 1, 2020
• Actual Primary Completion Date: September 1, 2020
• Estimated Study Completion Date: September 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nutritional counseling; Children with autism spectrum disorders to whom administer nutritional counseling	Behavioral: Nutritional counseling; Nutritional counseling about mediterranean diet
No Intervention: Controls; No intervention

Outcome Measures

Primary Outcome Measures :

1. Adherence to Mediterranean Diet [ Time Frame: change from baseline at 12 months ]
   Evaluation of mediterranea diet through score aiming to assess the mediterranean diet adhesion (Kidmed score; minimum value 0-worse maximum value 12-better)

Secondary Outcome Measures :

1. Change in food selectivity [ Time Frame: change from baseline at 12 months ]
   Evaluation of Food Preferences Inventory score (cut off 47; <47 selective child)
2. Change in eating habits [ Time Frame: change from baseline at 12 months ]
   Evaluation of 3-day diary foods

Other Outcome Measures:

1. change in auxological parameters [ Time Frame: change from baseline at 12 months ]
   Evaluation of body growth, height

Eligibility Criteria

• Ages Eligible for Study: 24 Months to 48 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• diagnosis of autism spectrum disorders

Exclusion Criteria:

• Age at enrollment <24 or> 48 months.
• Concomitant presence of other chronic diseases
• epilepsy,
• neurological syndromes,
• immunodeficiencies,
• diabetes,
• congenital heart disease,
• autoimmune diseases,
• inborn errors of metabolism,
• tuberculosis,
• cystic fibrosis,
• chronic respiratory tract diseases,
• inflammatory bowel disease,
• celiac disease,
• eosinophilic pathologies of the gastrointestinal tract,
• functional gastrointestinal disorders,
• obesity,
• tumors,
• malnutrition • Major malformations or previous surgery of the gastrointestinal / urinary / respiratory tract.

Contacts and Locations

Locations

Italy

University of Naples Federico II; Recruiting

Naples, Italy, 80131

Contact: Roberto Berni Canani 0817462680 berni@unina.it

Sponsors and Collaborators

Federico II University

More Information

• Responsible Party: Roberto Berni Canani, Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies, Federico II University
• ClinicalTrials.gov Identifier: NCT04652388
• Other Study ID Numbers: 353/20
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders