Impact of Nutritional Counselling in Children With Autism

The Impact of Nutritional Counselling in Children With Autistic Spectrum Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Nutritional counseling

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food selectivity	Evaluation of Food Preferences Inventory score (cut off 47; <47 selective child)	change from baseline at 12 months
Change in eating habits	Evaluation of 3-day diary foods	change from baseline at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in auxological parameters	Evaluation of body growth, height	change from baseline at 12 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (ACTUAL): December 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 353/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No