Skip to content

Study evaluating how an anti-inflammatory diet (Neurogutplus) can help children with autism spectrum disorder to improve inflammatory profile , neuropsychological profile and praxic development

Quasi-experimental study evaluating the effect of an anti-inflammatory diet (Neurogutplus) compared to usual diet on inflammatory profile, neuropsychological profile and praxic development in children with autism spectrum disorder in Manizales, Colombia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15439377
Enrollment
30
Registered
2025-09-24
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervention with anti-inflammatory diet in children with autism spectrum disorder to improve inflammatory profile, neuropsychological profile and praxic development. Mental and Behavioural Disorders

Interventions

A quasi-experimental study was conducted with a total sample of 30 children. Participants were recruited and assessed for eligibility and all were distributed into two groups: ASD (n =18) and NT (n =

Sponsors

Ministerio de Ciencia, Tecnología e Innovación
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactLiliana Giraldo
liliana.giraldo@ucaldas.edu.co+57 3205836977

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026