Impact of Nutritional Counselling in Children With Autism

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

Tracking Information

• First Submitted Date: November 23, 2020
• First Posted Date: December 3, 2020
• Last Update Posted Date: December 3, 2020
• Actual Study Start Date: September 1, 2020
• Actual Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: 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: Impact of Nutritional Counselling in Children With Autism
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Autism Spectrum Disorder

Intervention

Behavioral: Nutritional counseling

Nutritional counseling about mediterranean diet

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 2, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2022
• Actual Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 24 Months to 48 Months (Child)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04652388
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Roberto Berni Canani, Federico II University
• Study Sponsor: Federico II University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Federico II University
• Verification Date: December 2020