{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T12:20:08Z","timestamp":1781526008682,"version":"3.54.1"},"reference-count":63,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2021,3,16]],"date-time":"2021-03-16T00:00:00Z","timestamp":1615852800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Associazione A.M.A.R. Down-Onlus","award":["DSB.AD006.203, DSB.AD006.245"],"award-info":[{"award-number":["DSB.AD006.203, DSB.AD006.245"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antioxidants"],"abstract":"<jats:p>Down syndrome (DS) is a major genetic cause of intellectual disability. DS pathogenesis has not been fully elucidated, and no specific pharmacological therapy is available. DYRK1A overexpression, oxidative stress and mitochondrial dysfunction were described in trisomy 21. Epigallocatechin-3-gallate (EGCG) is a multimodal nutraceutical with antioxidant properties. EGCG inhibits DYRK1A overexpression and corrects DS mitochondrial dysfunction in vitro. The present study explores safety profiles in DS children aged 1\u20138 years treated with EGCG (10 mg\/kg\/die, suspended in omega-3, per os, in fasting conditions, for 6 months) and EGCG efficacy in restoring mitochondrial complex I and F0F1-ATP synthase (complex V) deficiency, assessed on PBMCs. The Griffiths Mental Developmental Scales\u2014Extended Revised (GMDS-ER) was used for developmental profiling. Results show that decaffeinated EGCG (&gt;90%) plus omega-3 is safe in DS children and effective in reverting the deficit of mitochondrial complex I and V activities. Decline of plasma folates was observed in 21% of EGCG-treated patients and should be carefully monitored. GMDS-ER scores did not show differences between the treated group compared to the DS control group. In conclusion, EGCG plus omega-3 can be safely administered under medical supervision in DS children aged 1\u20138 years to normalize mitochondria respiratory chain complex activities, while results on the improvement of developmental performance are still inconclusive.<\/jats:p>","DOI":"10.3390\/antiox10030469","type":"journal-article","created":{"date-parts":[[2021,3,16]],"date-time":"2021-03-16T12:01:02Z","timestamp":1615896062000},"page":"469","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["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"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2725-437X","authenticated-orcid":false,"given":"Iris","family":"Scala","sequence":"first","affiliation":[{"name":"Department of Maternal and Child Health, Federico II University Hospital, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Valenti","sequence":"additional","affiliation":[{"name":"Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, National Council of Research, 70126 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Scotto D\u2019Aniello","sequence":"additional","affiliation":[{"name":"Department of Translational Medical Sciences, Section of Pediatrics, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Marino","sequence":"additional","affiliation":[{"name":"Department of Translational Medical Sciences, Section of Pediatrics, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9311-9099","authenticated-orcid":false,"given":"Maria Pia","family":"Riccio","sequence":"additional","affiliation":[{"name":"Department of Maternal and Child Health, Federico II University Hospital, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6025-2870","authenticated-orcid":false,"given":"Carmela","family":"Bravaccio","sequence":"additional","affiliation":[{"name":"Department of Maternal and Child Health, Federico II University Hospital, 80131 Naples, Italy"},{"name":"Department of Translational Medical Sciences, Section of Pediatrics, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2438-6449","authenticated-orcid":false,"given":"Rosa Anna","family":"Vacca","sequence":"additional","affiliation":[{"name":"Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, National Council of Research, 70126 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pietro","family":"Strisciuglio","sequence":"additional","affiliation":[{"name":"Department of Translational Medical Sciences, Section of Pediatrics, Federico II University, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,3,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1016\/j.neubiorev.2019.01.001","article-title":"Down syndrome: Neurobiological alterations and therapeutic targets","volume":"98","author":"Vacca","year":"2019","journal-title":"Neurosci. 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