Epigallocatechin-3-Gallate Plus Omega-3 Restores the Mitochondrial Complex I and F0F1-ATP Synthase Activities in PBMCs of Young Children with Down Syndrome: A Pilot Study of Safety and Efficacy.

摘要: Down syndrome (DS) is a major genetic cause of intellectual disability. DS pathogenesis has not been fully elucidated, and no specific pharmacological therapy available. DYRK1A overexpression, oxidative stress mitochondrial dysfunction were described in trisomy 21. Epigallocatechin-3-gallate (EGCG) multimodal nutraceutical with antioxidant properties. EGCG inhibits overexpression corrects vitro. The present study explores safety profiles children aged 1–8 years treated (10 mg/kg/die, suspended omega-3, per os, fasting conditions, for 6 months) efficacy restoring complex I F0F1-ATP synthase (complex V) deficiency, assessed on PBMCs. Griffiths Mental Developmental Scales—Extended Revised (GMDS-ER) was used developmental profiling. Results show that decaffeinated (>90%) plus omega-3 safe effective reverting the deficit V activities. Decline plasma folates observed 21% EGCG-treated patients should be carefully monitored. GMDS-ER scores did differences between group compared to control group. In conclusion, can safely administered under medical supervision normalize mitochondria respiratory chain activities, while results improvement performance are still inconclusive.