An interventional study of Poly-unsaturated fatty acids supplementation and Neuropsychological intervention in Dyslexia, Developmental, sponsored by IRCCS Eugenio Medea. Recruiting at 2 sites in Italy. Open to participants aged 7 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Treatment
Poly-unsaturated fatty acids (PUFAs) represent a component of lipids that covers a relevant role in human diet and biological functions such as provision of energy, functionality of cell membranes and tissue metabolism. Fatty acids carbon chains can be saturated (with no presence of double bonds) or unsaturated (with one or more double bonds). PUFAs fall into the unsaturated group, and they can be divided into two classes: omega-3 (n-3) and omega-6 (n-6) fatty acids (FAs). PUFAs are relevant components of cellular membranes, phospholipids, and precursors of eicosanoids, which influence neuronal development and functioning, docosahexaenoic acid (DHA) and arachidonic acid (AA) in fact are involved in cell growth, neural signaling, and gene expression. The main natural dietary source for Eicosapentaenoic acid (EPA) and DHA is fish oil. It has also been shown how the Magnocellular system, which includes the retinal ganglion cells, the lateral geniculate nucleus (for the visual system, while the medial geniculate nucleus would be involved for the auditory system) of the thalamus, the posterior parietal cortex, various areas visual of the cortex and part of the cerebellum, is sensitive to the contribution of fatty acids through nutrition. A deficit related to the Magnocellular system, specialized in the processing of stimuli with high temporal frequencies and low spatial frequencies, in both the visual and auditory modalities, has been proposed as one of the causes of Developmental Dyslexia (DD). According to this hypothesis, an alteration at the magnocellular level would affect reading by hampering temporal processing of the visual signal and would reduce the quality of the phonological representations due to imperfect acoustic analysis of the incoming phonemes. It is therefore possible to hypothesize that supplementation of PUFA in dyslexic children would improve the functions of the M-system and thus create better conditions to the remediation of reading difficulties, especially through remediation programs specifically tapping visual attention and rapid processing of visual stimuli. The remediation program currently used at Scientific Institute (IRCCS) Medea, "Tachidino", based on tachistoscopic, hemisphere-specific stimulation and on training of selective visual-spatial attention, has exactly these characteristics.
Hence, the present study aims to test the efficacy of PUFA supplementation before and during treatment with Tachidino.
127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.
This study's planned enrollment of 125 is above the median of 71 across 106 interventional studies indexed under Dyslexia.
Browse Dyslexia studies →IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 51 are open to participants now.
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Inclusion criteria for control participants will be:
Exclusion Criteria:
Group 1 will be treated with the usual rehabilitation protocol adopted at IRCCS E. Medea (remote intervention delivered through the Tachidino platform). The program will be delivered during four weeks, starting two months after the pre-testing session. Additionally, the children will receive daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
Dietary Supplement: Poly-unsaturated fatty acids supplementation · Behavioral: Neuropsychological intervention
Group 2 will be treated with the usual rehabilitation protocol adopted at IRCCS E. Medea (remote intervention delivered through the Tachidino platform), delivered during four weeks, starting two months after the pre-testing session, exactly as Group 1. Additionally, the children will receive daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
Behavioral: Neuropsychological intervention · Dietary Supplement: Placebo
Groups 3 will receive only daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
Dietary Supplement: Poly-unsaturated fatty acids supplementation
Groups 4 will receive only daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
Dietary Supplement: Placebo
Typically Developing participants, as a comparison group for experimental tasks and for PUFA levels in the blood
Daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
Also known as: Equazen Eye Q chewable capsules
Rehabilitation protocol adopted at IRCCS "E. Medea" (remote intervention delivered through the Tachidino platform), delivered during four weeks, starting two months after the pre-testing session.
Also known as: Tachidino
Daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
Also known as: Equazen Eye Q red Placebo chewable capsules
PUFA supplementation effects on the results of neuropsychological intervention
Difference in treatment-related changes (post-test minus pre-test) observed in reading measures (speed and accuracy in word, nonword and text reading; average of the scores expressed as z-scores with respect to age norms) between the experimental group (Tachidino + PUFA supplementation) and the comparison group (Tachidino + placebo)
Time frame: 3 months
Changes in Rapid Automatized Naming (RAN) due to supplementation with PUFAs
Difference in change-scores (i.e. post-test minus pre-test) observed in Rapid Automatized Naming (z-scores with respect to age norms) in the experimental group versus placebo
Time frame: 3 months
Changes in visual search functions due to supplementation with PUFAs
Difference in change-scores (i.e. post-test minus pre-test) observed in Visual Search scores (z-scores with respect to age norms) in the experimental group versus placebo
Time frame: 3 months
Changes in Magnocellular functions due to supplementation with PUFAs
Difference in change-scores (i.e. post-test minus pre.test scores) observed in neuropsychological measures related to Magnocellular functions (Magnocellular tasks in the visual modality, efficiency expressed in msec) in the experimental group versus placebo
Time frame: 3 months
Correlations between blood levels of PUFA and reading performance
Pearson's correlation index between PUFA levels in the blood (Ratio omega-6/omega-3) and reading performance expressed in z-scores
Time frame: Baseline
Correlations between blood levels of PUFA and writing performance
Pearson's correlation index between PUFA levels in the blood (Ratio omega-6/omega-3) and writing performance expressed in z-scores
Time frame: Baseline
Change in blood levels of PUFAs in children with Dyslexia
Changes (post-test versus pre-test levels) in blood levels of PUFAs (Ratio omega-6/omega-3) for children with DD after 3 months supplementation
Time frame: 3 months
Changes in blood levels of PUFAs relate to changes in reading performance in children with Dyslexia
Pearson's correlation index between changes in PUFA levels (i.e. post-test minus pre-test levels) in the blood (Ratio omega-6/omega-3) and change-scores (i.e. post-test minus pre-test scores) in reading performance in children with DD (expressed in z-scores)
Time frame: 3 months
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