Impact of Nutritional Counselling in Children With Autism
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nutritional counseling
Sponsored by
About this trial
This is an interventional other trial for Autism Spectrum Disorder
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.
Sites / Locations
- University of Naples Federico IIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional counseling
Controls
Arm Description
Children with autism spectrum disorders to whom administer nutritional counseling
No intervention
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change in food selectivity
Evaluation of Food Preferences Inventory score (cut off 47; <47 selective child)
Change in eating habits
Evaluation of 3-day diary foods
Full Information
NCT ID
NCT04652388
First Posted
November 23, 2020
Last Updated
December 2, 2020
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT04652388
Brief Title
Impact of Nutritional Counselling in Children With Autism
Official Title
The Impact of Nutritional Counselling in Children With Autistic Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutritional counseling
Arm Type
Experimental
Arm Description
Children with autism spectrum disorders to whom administer nutritional counseling
Arm Title
Controls
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
Nutritional counseling about mediterranean diet
Primary Outcome Measure Information:
Title
Adherence to Mediterranean Diet
Description
Evaluation of mediterranea diet through score aiming to assess the mediterranean diet adhesion (Kidmed score; minimum value 0-worse maximum value 12-better)
Time Frame
change from baseline at 12 months
Secondary Outcome Measure Information:
Title
Change in food selectivity
Description
Evaluation of Food Preferences Inventory score (cut off 47; <47 selective child)
Time Frame
change from baseline at 12 months
Title
Change in eating habits
Description
Evaluation of 3-day diary foods
Time Frame
change from baseline at 12 months
Other Pre-specified Outcome Measures:
Title
change in auxological parameters
Description
Evaluation of body growth, height
Time Frame
change from baseline at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
Phone
0817462680
Email
berni@unina.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of Nutritional Counselling in Children With Autism
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