Impact of Nutritional Counselling in Children With Autism

NCT04652388 | Unknown

• 1 other identifier: 353/20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in food selectivity

  change from baseline at 12 months

• Change in eating habits

  change from baseline at 12 months

Other Outcomes (1)

• change in auxological parameters

  change from baseline at 12 months

Study Arms (2)

Nutritional counseling

EXPERIMENTAL

Children with autism spectrum disorders to whom administer nutritional counseling

Behavioral: Nutritional counseling

Controls

NO INTERVENTION

No intervention

Interventions

Nutritional counseling BEHAVIORAL

Nutritional counseling about mediterranean diet

Nutritional counseling

Eligibility Criteria

• Age: 24 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of autism spectrum disorders

You may not qualify if:

• 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,

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 3, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

IT (1)