Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Milan | OTHER |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tachidino + PUFA supplementation | Experimental | 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. |
|
| Tachidino + Placebo | Active Comparator | 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. |
|
| PUFA supplementation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-unsaturated fatty acids supplementation | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Changes in visual search functions due to supplementation with PUFAs |
Not provided
Inclusion Criteria for DD participants will be:
Inclusion criteria for control participants will be:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Luisa Lorusso, PhD | Contact | 031877919 | 0039 | marialuisa.lorusso@lanostrafamiglia.it |
| Francesca Borasio, PhD | Contact | 031877919 | 0039 | francesca.borasio@lanostrafamiglia.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Luisa Lorusso, PhD | IRCCS Eugenio Medea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS "E. Medea" - La Nostra Famiglia | Recruiting | Bosisio Parini | (LC) | 23842 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35203933 | Background | Borasio F, Syren ML, Turolo S, Agostoni C, Molteni M, Antonietti A, Lorusso ML. Direct and Indirect Effects of Blood Levels of Omega-3 and Omega-6 Fatty Acids on Reading and Writing (Dis)Abilities. Brain Sci. 2022 Jan 27;12(2):169. doi: 10.3390/brainsci12020169. | |
| 36830737 | Background | Borasio F, De Cosmi V, D'Oria V, Scaglioni S, Syren ME, Turolo S, Agostoni C, Coniglio M, Molteni M, Antonietti A, Lorusso ML. Associations between Dietary Intake, Blood Levels of Omega-3 and Omega-6 Fatty Acids and Reading Abilities in Children. Biomolecules. 2023 Feb 15;13(2):368. doi: 10.3390/biom13020368. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004410 | Dyslexia |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Placebo Comparator | 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. |
|
| Control group | No Intervention | Typically Developing participants, as a comparison group for experimental tasks and for PUFA levels in the blood |
|
|
| Neuropsychological intervention | Behavioral | 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. |
|
|
| Placebo | Dietary Supplement | 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. |
|
|
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 |
| 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 | 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 | 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 | 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 | 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) | 3 months |
| IRCCS E.Medea, polo di Conegliano | Recruiting | Conegliano | TV | Italy |
|
| D009422 | Nervous System Diseases |
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |