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Nutrient supplementation to improve the behavior of children with Autism Spectrum Disorder

Probiotic and micronutrient supplementation to improve neurobehavior in children with Autism Spectrum Disorder: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5hs6ry4
Enrollment
Unknown
Registered
2023-05-18
Start date
2022-05-01
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

Autism Spectrum Disorder

Interventions

This is a randomized, two-arm, blinded clinical trial. Participants in each group will be blinded and randomly selected for composition in each group at the time of inclusion in the study. Thirty chil
Both groups will receive daily, for a period of 6 months, magnesium and vitamin B6 supplementation at a concentration of 6 mg/Kg and 0.6 mg/Kg of Mg-L-threonate and vitamin B6, respectively, in the fo
The amount to be administered will be calculated by a nutritionist (research participant) and guided to the responsible family member. For the intervention group, a sachet will be offered (colorless a
F02.463.551
E05.318.308.980

Sponsors

Universidade Federal de Santa Maria
Lead Sponsor
Universidade de Brasília - UnB
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Adults without depression diagnose or neurological disorders; age between 18 and 50 years

Exclusion criteria

Exclusion criteria: Beck Depression Inventory (BDI-II) baseline score of 12 or higher; use of drugs that interfere with cognition; mental health diagnose

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in the ability to recover autobiographical memories, evaluated by Autobiographical Memory Test (TMA). Data collected one week before the intervention and in the last week of the intervention.

Secondary

MeasureTime frame
It is expected to find, in Phase 2 of the study, a greater specificity of autobiographical memories recovered by the group that underwent the mindfulness program and the neutral mood induction procedure, compared to the others. As for the group that underwent the mindfulness program and underwent negative mood induction procedure, it is expected that there will be greater recovery of specific autobiographical memories than the group that also underwent negative mood induction procedure but did not practice mindfulness. In the other interactions, no significant differences are expected.

Countries

Brazil

Contacts

Public ContactJade de Araújo

Universidade de Brasília - UnB

jade.araujo@gmail.com+55-61-3107-6959

Outcome results

None listed

Source: REBEC (via WHO ICTRP)