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Impact of Nutritional Counselling in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04652388
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE December 3, 2020
Last Update Posted Date December 3, 2020
Actual Study Start Date  ICMJE September 1, 2020
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
  • Change in food selectivity [ Time Frame: change from baseline at 12 months ]
    Evaluation of Food Preferences Inventory score (cut off 47; <47 selective child)
  • Change in eating habits [ Time Frame: change from baseline at 12 months ]
    Evaluation of 3-day diary foods
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2020)
change in auxological parameters [ Time Frame: change from baseline at 12 months ]
Evaluation of body growth, height
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Impact of Nutritional Counselling in Children With Autism
Official Title  ICMJE The Impact of Nutritional Counselling in Children With Autistic Spectrum Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE Behavioral: Nutritional counseling
Nutritional counseling about mediterranean diet
Study Arms  ICMJE
  • Experimental: Nutritional counseling
    Children with autism spectrum disorders to whom administer nutritional counseling
    Intervention: Behavioral: Nutritional counseling
  • No Intervention: Controls
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Actual Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04652388
Other Study ID Numbers  ICMJE 353/20
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Roberto Berni Canani, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federico II University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP