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Abstract
Objectives: Previously, oxidative damage has been associated with severity of clinical symptoms and supplementation with antioxidants and essential polyunsaturated fatty acids (EPUFAs) was proposed to have beneficial effects in schizophrenia. We evaluated the effects of supplementation with EPUFAs and vitamin E in patients treated with haloperidol depot injection.
Design: This was a double-blind randomized placebo-controlled study with four arms (Placebo, vitamin E, EPUFAs, and vitamin E + EPUFAs). Biomarkers of oxidative stress, neurochemistry, psychopathology, and extrapyramidal symptoms were assessed at baseline and after 4 months.
Results: In EPUFAs group of patients, reduced glutathione concentration was increased compared to placebo. Concentration of oxidized glutathione was decreased in patients receiving vitamin E. In addition, compared to placebo a non-significant trend of increased activity of catalase and superoxide dismutase was observed in all three treatment groups. Patients receiving vitamin E experienced less motor retardation. No difference in extrapyramidal symptoms was found.
Discussion: Our study indicates that supplementation with vitamin E and EPUFAs may improve the antioxidative defense, especially glutathione system, while there is no major effect on symptoms severity. Supplemental treatment with EPUFAs and vitamin E in schizophrenia patients treated with haloperidol is potentially beneficial and a larger independent study appears warranted.
Acknowledgement
The authors acknowledge the contribution from Apomedica Pharmazeutische Produkte GmBH, Graz, Austria for providing vitamin E and EPUFAs capsules. Apomedica, however, had no role in the study design, analysis, interpretation, and reporting of the study.
Disclaimer statements
Contributors M.B., T.V., B.K.P., and I.G. conceived and designed the study. J.K. and B.K.P. evaluated psychopathology and extrapyramidal symptoms. M.B. and T.V. performed the biochemical analyses. M.B. and I.G. analyzed the data. M.B., T.V., and I.G. drafted the first manuscript. J.K. and B.K.P. provided scientific supervision. All authors reviewed and approved the final manuscript.
Funding This study was financially supported by the Slovenian Research Agency (ARRS Grant P1-0189).
Conflicts of interest None.
Ethics approval The study was approved by the National Medical Ethics Committee of the Republic of Slovenia (Ref. No. 147/05/08) and was performed in accordance with the ethical standards set by Declaration of Helsinki. The study was registered in EU Clinical Trials Register (EudraCT number: 2009-018054-33).