Malnourishment Clinical Trial
Official title:
Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Adequate nutrition is one of the critical biological processes to learning and cognitive development of children. And is understandable that malnourishment affect these processes. Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in cognitive development and academic performance. However, studies have been limited. Therefore is of interest to know the effects that has supplement with Omega-3 for children 8-12 years with malnutrition in a randomized, blind, placebo-controlled.
Adequate nutrition is one of the most critical biological processes to learning and
cognitive development of children, and malnourishment is understandable these processes are
affected. Moreover, in recent decades is has been investigated the beneficial effects of
Omega-3 in cognitive development and academic performance. However, studies have been
limited. The present study will investigate the efficacy of omega-3 fatty acids supplement
on cognition and academic performance in children attending elementary school.
The study will follow a randomized, double-blind, placebo-controlled design in which
children aged 6-12 years will followed for a period of three months to assess cognitive
development, academic performance and nutritional status . Intervention will take place in
elementary schools, where children will receive two intervention products daily and one more
in their houses. The products will contain omega-3 fatty acids, placebo, or only
neuropsychological evaluation (control group with normal nutrition children). At baseline,
and 3months cognitive tests will be administered and assess nutritional status. Compliance
will be measured weekly.
We hypothesize that after 12 months of intervention, children consuming omega-3 fatty acids
will have statistically significant higher improvement in scores on cognitive tests, than
placebo and normal nutrition children.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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