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Impact of Nutritional Counselling in Children With Autism

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

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

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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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652388

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University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani    0817462680    berni@unina.it   
Sponsors and Collaborators
Federico II University
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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    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders