NUTRARET: Effect of 2-Year Nutraceutical Supplementation on Redox Status and Visual Function of Patients With Retinitis Pigmentosa: A Randomized, Double-Blind, Placebo-Controlled Trial
Por:
L. OLIVARES-GONZALEZ, D. SALOM, E. GONZALEZ-GARCIA, D. HERVAS, N. MEJIA-CHIQUI, M. MELERO, S. VELASCO, B. MURESAN, I. CAMPILLO, N. VILA-CLERIGUES, E. LOPEZ-BRIZ, J. MERINO-TORRES, J. MILLAN, J. DEL CASTILLO and R. RODRIGO
Publicada:
21 mar 2022
Resumen:
Oxidative stress plays a major role in the pathogenesis of retinitis pigmentosa (RP). The main goal of this study was to evaluate the effect of 2-year nutritional intervention with antioxidant nutraceuticals on the visual function of RP patients. Secondly, we assessed how nutritional intervention affected ocular and systemic redox status. We carried out a randomized, double-blind, placebo-controlled study. Thirty-one patients with RP participated in the study. RP patients randomly received either a mixture of nutraceuticals (NUT) containing folic acid, vitamin B6, vitamin A, zinc, copper, selenium, lutein, and zeaxanthin or placebo daily for 2 years. At baseline and after 2-year of the nutritional supplementation, visual function, dietetic-nutritional evaluations, serum concentration of nutraceuticals, plasma and aqueous humor concentration of several markers of redox status and inflammation were assessed. Retinal function and structure were assessed by multifocal electroretinogram (mfERG), spectral domain-optical coherence tomography (SD-OCT) and automated visual field (VF) tests. Nutritional status was estimated with validated questionnaires. Total antioxidant capacity, extracellular superoxide dismutase (SOD3), catalase (CAT), and glutathione peroxidase (GPx) activities, protein carbonyl adducts (CAR) content, thiobarbituric acid reactive substances (TBARS) formation (as indicator of lipid peroxidation), metabolites of the nitric oxide (NOX) and cytokine (interleukin 6 and tumor necrosis factor alpha) concentrations were assessed by biochemical and immunological techniques in aqueous humor or/and blood. Bayesian approach was performed to determine the probability of an effect. Region of practical equivalence (ROPE) was used. At baseline, Bayesian analysis revealed a high probability of an altered ocular redox status and to a lesser extent systemic redox status in RP patients compared to controls. Twenty-five patients (10 in the treated arm and 15 in the placebo arm) completed the nutritional intervention. After 2 years of supplementation, patients who received NUT presented better retinal responses (mfERG responses) compared to patients who received placebo. Besides, patients who received NUT showed better ocular antioxidant response (SOD3 activity) and lower oxidative damage (CAR) than those who received placebo. This study suggested that long-term NUT supplementation could slow down visual impairment and ameliorate ocular oxidative stress.
Filiaciones:
:
Principe Felipe Res Ctr CIPF, Pathophysiol & Therapies Vis Disorders, Valencia, Spain
Joint Res Unit Rare Dis CIPF Hlth Res Inst Hosp L, Valencia, Spain
D. SALOM:
Manises Hosp, Dept Ophthalmol, Manises, Spain
Ctr Biomed Network Res Rare Dis CIBERER, Madrid, Spain
E. GONZALEZ-GARCIA:
Manises Hosp, Dept Neurosci, Manises, Spain
D. HERVAS:
Univ Politecn Valencia, Dept Appl Stat Operat Res & Qual, Valencia, Spain
N. MEJIA-CHIQUI:
Principe Felipe Res Ctr CIPF, Pathophysiol & Therapies Vis Disorders, Valencia, Spain
M. MELERO:
La Fe Univ Polytech Hosp, Serv Pharm, Valencia, Spain
:
Principe Felipe Res Ctr CIPF, Pathophysiol & Therapies Vis Disorders, Valencia, Spain
B. MURESAN:
Univ Gen Hosp, Serv Endocrinol & Nutr, Valencia, Spain
I. CAMPILLO:
Principe Felipe Res Ctr CIPF, Pathophysiol & Therapies Vis Disorders, Valencia, Spain
N. VILA-CLERIGUES:
La Fe Univ Polytech Hosp, Serv Pharm, Valencia, Spain
E. LOPEZ-BRIZ:
La Fe Univ Polytech Hosp, Serv Pharm, Valencia, Spain
J. MERINO-TORRES:
La Fe Univ & Polytech Hosp Spain, Serv Endocrinol & Nutr, Valencia, Spain
Joint Res Unit Endocrinol Nutr & Clin Dietet UV I, Valencia, Spain
:
Joint Res Unit Rare Dis CIPF Hlth Res Inst Hosp L, Valencia, Spain
Ctr Biomed Network Res Rare Dis CIBERER, Madrid, Spain
IIS La Fe Spain, Mol Cellular & Genom Biomed, Valencia, Spain
J. DEL CASTILLO:
Joint Res Unit Endocrinol Nutr & Clin Dietet UV I, Valencia, Spain
Univ Valencia UV, Inst Mat Sci, Food & Hlth Lab, Valencia, Spain
:
Principe Felipe Res Ctr CIPF, Pathophysiol & Therapies Vis Disorders, Valencia, Spain
Joint Res Unit Rare Dis CIPF Hlth Res Inst Hosp L, Valencia, Spain
Ctr Biomed Network Res Rare Dis CIBERER, Madrid, Spain
Joint Res Unit Endocrinol Nutr & Clin Dietet UV I, Valencia, Spain
Univ Valencia UV, Dept Physiol, Valencia, Spain
Green Published, gold
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