Poly-unsaturated Fatty Acids and Developmental Dyslexia

NCT04287530 | Recruiting

• 1 other identifier: 677
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dyslexia, Developmental

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Changes in Rapid Automatized Naming (RAN) due to supplementation with PUFAs

  3 months

• Changes in visual search functions due to supplementation with PUFAs

  3 months

• Changes in Magnocellular functions due to supplementation with PUFAs

  3 months

• Correlations between blood levels of PUFA and reading performance

  Baseline

• Correlations between blood levels of PUFA and writing performance

  Baseline

Study Arms (5)

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.

Dietary Supplement: Poly-unsaturated fatty acids supplementation; Behavioral: Neuropsychological intervention

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.

Behavioral: Neuropsychological intervention; Dietary Supplement: Placebo

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.

Dietary Supplement: Poly-unsaturated fatty acids supplementation

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.

Dietary Supplement: Placebo

Control group

NO INTERVENTION

Typically Developing participants, as a comparison group for experimental tasks and for PUFA levels in the blood

Interventions

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.

Also known as: Equazen Eye Q chewable capsules

PUFA supplementation; Tachidino + PUFA supplementation

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.

Also known as: Tachidino

Tachidino + PUFA supplementation; Tachidino + Placebo

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.

Also known as: Equazen Eye Q red Placebo chewable capsules

Placebo; Tachidino + Placebo

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A formal diagnosis of Developmental Dyslexia, Specific Reading Disorders or Mixed Learning Disorders
• Age between 7 and 15
• Attending at least the third class of primary school
• Monolingual speakers or bilingual speakers with perfect mastery of the Italian language (equivalent to monolinguals)
• Intelligence Quotient (IQ) \>= 80
• At least one z-score below -2 Standard Deviations from age mean in at least one of the following tests: text reading, word reading, nonword reading (Dyslexia and Dysorthography (DDE-2) battery, Memory Training (MT) tests)
• Not having received any specific rehabilitation treatment for dyslexia before
• Age between 7 and 15
• Attending at least the third class of primary school
• Monolingual speakers or bilingual speakers with perfect mastery of the Italian language (equivalent to monolinguals)
• no reported record of difficulties with reading nor specific learning disorders
• Intelligence Quotient (IQ) \>= 80
• No z-score below -1,5 Standard Deviations from age mean in any of the following tests: text reading, word reading, nonword reading ("DDE-2" battery, "MT" tests)

You may not qualify if:

• Intellectual disability
• Attention Deficit with Hyperactivity (ADHD)
• Neurological disorders
• Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.
• Allergy to fish and shellfish
• Absorption Disorders (malabsorption)
• Children already (or recently) on a diet with PUFA supplementation
• Children on a therapy with psychoactive medications (anti-depressant, anxiety-control etc.) or with supplements who have not reached a stable administration schedule.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• University of Milan: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (2)

IRCCS "E. Medea" - La Nostra Famiglia

Bosisio Parini, (LC), 23842, Italy

RECRUITING

IRCCS E.Medea, polo di Conegliano

Conegliano, TV, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 35203933 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.

  PMID: 36830737 BACKGROUND

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maria Luisa Lorusso, PhD

  IRCCS Eugenio Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Luisa Lorusso, PhD

CONTACT

031877919; marialuisa.lorusso@lanostrafamiglia.it

Francesca Borasio, PhD

CONTACT

031877919; francesca.borasio@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 27, 2020
• Study Start: May 2, 2020
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

IT (2)