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      Effect of Nigella Sativa Oil on Oxidative Stress, Inflammatory, and Glycemic Control Indices in Diabetic Hemodialysis Patients: A Randomized Double-Blind, Controlled Trial

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          Abstract

          Background and Aims

          Diabetes is a leading cause of renal failure. High levels of oxidative stress and inflammation in patients with renal diabetes lead to various disorders and mortality. This study was performed to determine the effect of Nigella sativa (NS) supplementation on superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP), glycosylated hemoglobin (HbA1c), fasting blood sugar (FBS), and insulin (INS) in patients with diabetes mellitus undergoing hemodialysis (HD).

          Methods

          In this randomized, double-blind, placebo-controlled clinical trial, a total of 46 diabetic HD patients were randomly divided into NS ( n = 23) and placebo ( n = 23) groups. NS group received 2 g/day of NS oil, and the placebo group received paraffin oil for 12 weeks. Serum levels of SOD, MDA, TAC, hs-CRP, HbA1C, FBS, and INS were measured before and after the study.

          Results

          Compared to baseline values, SOD, TAC, and INS levels increased, whereas MDA, hs-CRP, HbA1c, and FBS significantly decreased. After adjusting for covariates using the ANCOVA test, changes in the concentrations of SOD ( p = .040), MDA ( p = .025), TAC ( p=<.001), hs-CRP ( p = .017), HbA1c ( p = .014), and FBS ( p = .027) were statistically significant compared to the placebo group. Intergroup changes in INS were not significant. Additionally, there were no notable side effects during the research.

          Conclusions

          This study found that NS supplementation significantly enhanced the levels of SOD, MDA, TAC, hs-CRP, HbA1c, and FBS in diabetic HD patients.

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          Most cited references55

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          Type 2 diabetes mellitus, oxidative stress and inflammation: examining the links.

          Oluwafemi Oguntibeju (2019)
          Diabetes mellitus has been recognised as one of the four major non-communicable diseases that demands urgent attention from all key shareholders globally in an effort to address its prevalence and associated complications. It is considered as a top 10 cause of death globally, killing about 1.6 million people worldwide and is seen as the third highest risk factor for worldwide premature mortality due to hyperglycaemia and hyperglycaemic-induced oxidative stress and inflammation. There is a strong link between hyperglycaemia, hyperglycaemic-induced oxidative stress, inflammation and the development and progression of type 2 diabetes mellitus. Various reports have shown that chronic low-grade inflammation is associated with the risk of developing type 2 diabetes and that sub-clinical inflammation contributes to insulin resistance and is linked to the characteristics of metabolic syndrome which include hyperglycaemia. Oxidative stress stimulates the generation of inflammatory mediators and inflammation in turn enhances the production of reactive oxygen species. This interaction between diabetes, oxidative stress and inflammation is the primary motivation for the compilation of this review. Based on previous studies, the review examines the interaction between diabetes, oxidative stress and inflammation, factors promoting prevalence of diabetes mellitus, mechanisms involved in hyperglycaemia-induced oxidative stress with particular focus on type 2 diabetes and selected diabetic complications.
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            Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis.

            Goran Bjelakovic, Dimitrinka Nikolova, Lise Lotte Gluud … (2007)
            Antioxidant supplements are used for prevention of several diseases. To assess the effect of antioxidant supplements on mortality in randomized primary and secondary prevention trials. DATA SOURCES AND TRIAL SELECTION: We searched electronic databases and bibliographies published by October 2005. All randomized trials involving adults comparing beta carotene, vitamin A, vitamin C (ascorbic acid), vitamin E, and selenium either singly or combined vs placebo or vs no intervention were included in our analysis. Randomization, blinding, and follow-up were considered markers of bias in the included trials. The effect of antioxidant supplements on all-cause mortality was analyzed with random-effects meta-analyses and reported as relative risk (RR) with 95% confidence intervals (CIs). Meta-regression was used to assess the effect of covariates across the trials. We included 68 randomized trials with 232 606 participants (385 publications). When all low- and high-bias risk trials of antioxidant supplements were pooled together there was no significant effect on mortality (RR, 1.02; 95% CI, 0.98-1.06). Multivariate meta-regression analyses showed that low-bias risk trials (RR, 1.16; 95% CI, 1.04[corrected]-1.29) and selenium (RR, 0.998; 95% CI, 0.997-0.9995) were significantly associated with mortality. In 47 low-bias trials with 180 938 participants, the antioxidant supplements significantly increased mortality (RR, 1.05; 95% CI, 1.02-1.08). In low-bias risk trials, after exclusion of selenium trials, beta carotene (RR, 1.07; 95% CI, 1.02-1.11), vitamin A (RR, 1.16; 95% CI, 1.10-1.24), and vitamin E (RR, 1.04; 95% CI, 1.01-1.07), singly or combined, significantly increased mortality. Vitamin C and selenium had no significant effect on mortality. Treatment with beta carotene, vitamin A, and vitamin E may increase mortality. The potential roles of vitamin C and selenium on mortality need further study.
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              Mechanism of Generation of Oxidative Stress and Pathophysiology of Type 2 Diabetes Mellitus: How Are They Interlinked?

              Kanwal Rehman, Muhammad Akash (2017)
              Oxidative stress has been considered as a major hallmark for the pathogenesis and development of type 2 diabetes mellitus (T2DM), but still it is debatable whether it is a mere aggregation of inflammatory-induced responses or clinical entity that underlies with various pathophysiological factors. In this regard, the latest studies have shown the increasing trends for the involvement of reactive oxygen species (ROS) and oxidative stress in the pathogenesis and development of T2DM. ROS are highly reactive species and almost all cellular components are chemically changed due to the influence of ROS that ultimately results in the production of lipid peroxidation. Lipid peroxidation is a major causative factor for the development of oxidative stress that leads to overt T2DM and its associated micro- and macro-vascular complications. In this article, we have briefly described the role of various causative factors, transcriptional and metabolic pathways which are responsible to increase the production of oxidative stress, a most pivotal factor for the pathogenesis and development of T2DM. Therefore, we conclude that measurement of oxidative stress biomarkers may be one of the optional tool for the diagnosis and prediction of T2DM. Moreover, the key findings described in this article also provides a new conceptual framework for forthcoming investigations on the role of oxidative stress in pathogenesis of T2DM and drug discovery. J. Cell. Biochem. 118: 3577-3585, 2017. © 2017 Wiley Periodicals, Inc.
              Article 0 comments Cited 158 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Ali Tarighat-Esfanjani:
                ORCID: https://orcid.org/0000-0003-0481-3685
                Journal
                Journal ID (nlm-ta): Evid Based Complement Alternat Med
                Journal ID (iso-abbrev): Evid Based Complement Alternat Med
                Journal ID (publisher-id): ECAM
                Title: Evidence-based Complementary and Alternative Medicine : eCAM
                Publisher: Hindawi
                ISSN (Print): 1741-427X
                ISSN (Electronic): 1741-4288
                Publication date Collection: 2022
                Publication date (Electronic): 15 April 2022
                Publication date PMC-release: 15 April 2022
                Volume: 2022
                Electronic Location Identifier: 2753294
                Affiliations
                1Student Research Committee, Student Research Center, Tabriz University of Medical Sciences, Tabriz, IR, Iran
                2Department of Internal Medicine, School of Medicine, Imam Reza Medical Research and Training Hospital, Tabriz University of Medical Sciences, Tabriz, IR, Iran
                3Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran
                4Department of Nutrition Sciences, Varastegan Institute for Medical Sciences, Mashhad, IR, Iran
                5Nutrition Research Center, Clinical Nutrition Department, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran
                Author notes

                Academic Editor: Wen yi Kang

                Author information
                https://orcid.org/0000-0003-3177-6381
                https://orcid.org/0000-0002-8476-0482
                https://orcid.org/0000-0001-9239-768X
                https://orcid.org/0000-0003-0481-3685
                Article
                DOI: 10.1155/2022/2753294
                PMC ID: 9033343
                PubMed ID: 35463059
                SO-VID: 774f4612-473f-404d-af51-6c12b3471c1a
                Copyright © Copyright © 2022 Alireza Rahmani et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 12 January 2022
                Date accepted : 18 March 2022
                Funding
                Funded by: Tabriz University of Medical Sciences
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Complementary & Alternative medicine
                Data availability:
                ScienceOpen disciplines: Complementary & Alternative medicine

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