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Effect of a2 milk, biofortified or not, on the diet of children with Autism Spectrum Disorder

Effect of milk biofortified with selenium and vitamin e from cows with genotype a2a2 in the diet of children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-26b5dtq
Enrollment
Unknown
Registered
2023-08-31
Start date
2022-10-03
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Gastrointestinal disorders

Interventions

This is a randomized, simpels-blind clinical trial. Using 30 autistic children aged 3 to 10 years. The randomization process was performed in blocks with a computer-generated list used to distribute t
Experimental Group - 15 children consumption of A2 milk bioforitified with selenium and vitamin E (500 ml/ day) during the period of 84 days.
F.84
E02.642

Sponsors

Faculdade de Zootecnia e Engenharia de Alimentos da Universidade de São Paulo
Lead Sponsor
Fonterra Co-operative Group Ltd
Collaborator

Eligibility

Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: Child aged 3 to 10 years; male and female gender; diagnosis of Autism Spectrum Disorder (ASD) according to the evaluation criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); being classified into one of the three grades of autism

Exclusion criteria

Exclusion criteria: Positive diagnosis for cow’s milk protein allergy. Use of antibiotics or in the last 7 days prior to the study

Design outcomes

Primary

MeasureTime frame
Gastrointestinal discomfort. Oxidative stress. Serum levels of non-enzymatic (selenium, vitamin E) and enzymatic (glutathione peroxidase) antioxidants. Serum levels of immuno-inflammatory cytokines (IL-4, CRP). Serum levels of beta-casomorphin-7. IV dipeptidyl peptidase serum levels.;Milk A2 is expected to reduce gastrointestinal discomforts related to milk consumption—

Secondary

MeasureTime frame
It is expected to increase the levels of antioxidants, selenium and vitamin E, and consequently increase the levels of enzymatic antioxidants such as glutathione peroxidase, catalase and suporoxide dismutase—

Countries

Brazil

Contacts

Public ContactAna Maria Vidal

Universidade de São Paulo

anavidal@usp.br+55 019 3565-6841

Outcome results

None listed

Source: REBEC (via WHO ICTRP)