Intervention with anti-inflammatory diet in children with autism spectrum disorder to improve inflammatory profile, neuropsychological profile and praxic development. Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion (Autism spectrum disorder groups): 1. Children aged 6-17 years with confirmed diagnosis of level I ASD (APA, 2013). 2. Any gender. 3. Caregiver agreement to participate and follow dietary guidelines. 4. Active affiliation with the Colombian General Social Security System. Inclusion (Neurotypical groups): 1. Children aged 6-17 years and could not have a diagnosis of autism or any other developmental disorder. 2. Any gender. 3. Caregiver agreement to participate and follow dietary guidelines. 4. Active affiliation with the Colombian General Social Security System
Exclusion criteria
Exclusion criteria: Exclusion (Autism spectrum disorder groups): 1. Children with food intolerance or history of milk protein allergy 2. Children with neuromuscular, systemic inflammatory, metabolic, musculoskeletal, or immune disorders 3. Children with a nutritional diet at the time of the study. Exclusion (Neurotypical groups): 1. Children with food intolerance or history of milk protein allergy 2. Children with autism spectrum disorder, neuromuscular, systemic inflammatory, metabolic, musculoskeletal, or immune disorders 3. Children with a nutritional diet at the time of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma concentrations of TGF-ß1, IFN-?, IL-8, and MIP-1ß measured using ProcartaPlex™ Human Th1/Th2 & Chemokine Panel 20-plex (Luminex xMAP® technology) at baseline (week 0) and after 12 weeks of dietary intervention. 2. Neuropsychological profile measured using Wechsler Intelligence Scale for Children-IV (Fourth edition) and child neuropsychological assessment (ENI 2) at baseline and after 12 weeks. 3. Praxic development and psychomotor profile measured using Batería Psicomotora Da Fonseca (BPM) at baseline and after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MCP-1, Eotaxin, IP-10, GRO-a, RANTES, SDF-1a, IL-18, and MIP-1a measured using ProcartaPlex™ 20-plex panel at baseline (week 0) and after 12 weeks. 2. PBMC gene expression profile measured using single-cell RNA sequencing (scRNA-seq) at baseline and after 12 weeks. 3. Nutritional status and body composition (BMI-for-age, height-for-age, weight-for-age z-scores) measured measured using anthropometric techniques (skinfolds, circumferences) at baseline and after 12 weeks. 4. Dietary adherence measured using weekly caregiver food logs, interviews, verification of unused food packages at throughout the 12-week intervention. 5. Psychomotor factors of tonicity, balance, body awareness, spatial-temporal structuring, laterality, global praxia, and fine praxia measured using Batería Psicomotora Da Fonseca (BPM) at baseline and after 12 weeks. 6. Immune-behavioral network reorganization measured using PCA and network analysis at baseline and after 12 weeks. | — |
Countries
Colombia