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Completed

NCT Number: NCT04652388

Impact of Nutritional Counselling in Children With Autism

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.

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Key information

Age range

24 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of autism spectrum disorders
  • presence of food selectivity

Exclusion criteria

  • Age at enrollment <24 or> 60 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.

Treatment and study plan

Nutritional counseling

Behavioral

Nutritional counseling about mediterranean diet

Primary outcomes

  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)

Secondary outcomes

  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)

  2. Change in eating habits

    Time frame: change from baseline at 12 months

    Evaluation of 3-day diary foods

Other outcomes

  1. change in auxological parameters

    Time frame: change from baseline at 12 months

    Evaluation of body growth, height

  2. Change in the quality of life of parents

    Time frame: change from baseline at 12 months

    Evaluation of the quality of life of parents through the questionnaire EUROHIS-QOL 8

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

The Impact of Nutritional Counselling in Children With Autistic Spectrum Disorder

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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