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      Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial

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          Abstract

          Background

          The dramatic increase in the prevalence of type 2 diabetes mellitus (T2DM) is a global major challenge to health. Circulating microRNAs have been suggested as promising biomarkers for different disorders such as diabetes. Imbalances in the gut microbiome have been revealed to contribute to the progression of multiple diseases including T2DM. Recently, the consumption of probiotics and synbiotics in the treatment of various diseases has shown a substantial growth. The anti-diabetes and anti-inflammatory effects of synbiotics have been indicated, which may be due to their beneficial effects on the gut microbiome. However, further research is needed to assess the effects of synbiotics on the microbiota and their impacts on expression of microRNAs relating to T2DM. Thus, we will aim to assess the effects of synbiotics on microbiota, serum level of tumor necrosis factor-α (TNF-α), and expression of microRNA-126 and microRNA-146a in patients with T2DM.

          Methods

          Seventy-two patients with T2DM will be recruited in this double-blind randomized parallel placebo-controlled clinical trial. After block matching based on age and sex, participants will be randomly assigned to receive 1000 mg/day synbiotic (Familact) or placebo for 12 weeks. The microRNA-126 and microRNA-146a expression levels will be measured by real-time polymerase chain reaction and serum TNF-α level will be assessed by enzyme-linked immunosorbent assay kit at the beginning and at the end of the study. Determination of the gut microbiota will be done by quantitative polymerase chain reaction methods at baseline and at the end of the trial. Biochemical assessments (glycemic and lipid profiles) will also be conducted at onset and end of the study.

          Discussion

          This is the first randomized controlled trial that will determine the effect of synbiotic supplementation on the gut microbiota and its probable impacts on serum levels of TNF-α and expression of related microRNAs in patients with T2DM.

          Trial registration

          Iranian Registry of Clinical Trials: IRCT20180624040228N2. Registered on 27 March 2019. http://www.irct.ir/trial/38371.

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          Most cited references24

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          Inflammation: the link between insulin resistance, obesity and diabetes.

          Paresh Dandona, Ahmad Aljada, Arindam Bandyopadhyay (2004)
          Recent data have revealed that the plasma concentration of inflammatory mediators, such as tumour necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6), is increased in the insulin resistant states of obesity and type 2 diabetes, raising questions about the mechanisms underlying inflammation in these two conditions. It is also intriguing that an increase in inflammatory mediators or indices predicts the future development of obesity and diabetes. Two mechanisms might be involved in the pathogenesis of inflammation. Firstly, glucose and macronutrient intake causes oxidative stress and inflammatory changes. Chronic overnutrition (obesity) might thus be a proinflammatory state with oxidative stress. Secondly, the increased concentrations of TNF-alpha and IL-6, associated with obesity and type 2 diabetes, might interfere with insulin action by suppressing insulin signal transduction. This might interfere with the anti-inflammatory effect of insulin, which in turn might promote inflammation.
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            Alterations in fecal microbiota composition by probiotic supplementation in healthy adults: a systematic review of randomized controlled trials

            Nadja Kristensen, Thomas Bryrup, Kristine Allin … (2016)
            Background The effects of probiotic supplementation on fecal microbiota composition in healthy adults have not been well established. We aimed to provide a systematic review of the potential evidence for an effect of probiotic supplementation on the composition of human fecal microbiota as assessed by high-throughput molecular approaches in randomized controlled trials (RCTs) of healthy adults. Methods The survey of peer-reviewed papers was performed on 17 August 2015 by a literature search through PubMed, SCOPUS, and ISI Web of Science. Additional papers were identified by checking references of relevant papers. Search terms included healthy adult, probiotic, bifidobacterium, lactobacillus, gut microbiota, fecal microbiota, intestinal microbiota, intervention, and (clinical) trial. RCTs of solely probiotic supplementation and placebo in healthy adults that examined alteration in composition of overall fecal microbiota structure assessed by shotgun metagenomic sequencing, 16S ribosomal RNA sequencing, or phylogenetic microarray methods were included. Independent collection and quality assessment of studies were performed by two authors using predefined criteria including methodological quality assessment of reports of the clinical trials based on revised tools from PRISMA/Cochrane and by the Jadad score. Results Seven RCTs investigating the effect of probiotic supplementation on fecal microbiota in healthy adults were identified and included in the present systematic review. The quality of the studies was assessed as medium to high. Still, no effects were observed on the fecal microbiota composition in terms of α-diversity, richness, or evenness in any of the included studies when compared to placebo. Only one study found that probiotic supplementation significantly modified the overall structure of the fecal bacterial community in terms of β-diversity when compared to placebo. Conclusions This systematic review of the pertinent literature demonstrates a lack of evidence for an impact of probiotics on fecal microbiota composition in healthy adults. Future studies would benefit from pre-specifying the primary outcome and transparently reporting the results including effect sizes, confidence intervals, and P values as well as providing a clear distinction of between-group and within-group comparisons.
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              Modulation of K-Ras-dependent lung tumorigenesis by MicroRNA-21.

              Mark E Hatley, David Patrick, Matthew R. Garcia … (2010)
              Lung cancer is the leading cause of cancer-related deaths in the world, and non-small-cell lung cancer (NSCLC) accounts for 80% of cases. MicroRNA-21 (miR-21) expression is increased and predicts poor survival in NSCLC. Although miR-21 function has been studied in vitro with cancer cell lines, the role of miR-21 in tumor development in vivo is unknown. We utilize transgenic mice with loss-of-function and gain-of-function miR-21 alleles combined with a model of NSCLC to determine the role of miR-21 in lung cancer. We show that overexpression of miR-21 enhances tumorigenesis and that genetic deletion of miR-21 partially protects against tumor formation. MiR-21 drives tumorigenesis through inhibition of negative regulators of the Ras/MEK/ERK pathway and inhibition of apoptosis. Copyright © 2010 Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Fahime Zeinali: fghzeinaly@yahoo.com
                Seyed Mohsen Aghaei Zarch: mosenaghaei123@gmail.com
                Mohammad Yahya Vahidi Mehrjardi: mmvahidi@gmail.com
                Seyed Mehdi Kalantar: smkyzd@gmail.com
                Alireza Jahan-mihan: alireza.jahan-mihan@unf.edu
                Elham Karimi-Nazari: elham939k@gmail.com
                Hossein Fallahzadeh: fallahzadeh.ho@gmail.com
                Mahdieh Hosseinzadeh-Shamsi-Anar: hoseinzade.mahdie@gmail.com
                Masoud Rahmanian: drmasoudrahmanian@yahoo.com
                Mohammad Reza Fazeli: fazelimo@sina.tums.ac.ir
                Hassan Mozaffari-Khosravi: mozaffari.kh@gmail.com
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1745-6215
                Publication date (Electronic): 14 April 2020
                Publication date PMC-release: 14 April 2020
                Publication date Collection: 2020
                Volume: 21
                Electronic Location Identifier: 324
                Affiliations
                [1 ]GRID grid.412505.7, ISNI 0000 0004 0612 5912, Department of Nutrition, School of Public Health, , Shahid Sadoughi University of Medical Sciences, ; Yazd, Iran
                [2 ]GRID grid.412505.7, ISNI 0000 0004 0612 5912, Nutrition and Food Security Research Center, , Shahid Sadoughi University of Medical Sciences, ; Yazd, Iran
                [3 ]GRID grid.412505.7, ISNI 0000 0004 0612 5912, Department of Genetics, Faculty of Medicine, , Shahid Sadoughi University of Medical Sciences, ; Yazd, Iran
                [4 ]GRID grid.412505.7, ISNI 0000 0004 0612 5912, Yazd Diabetic Research Center, , Shahid Sadoughi University of Medical Sciences, ; Yazd, Iran
                [5 ]GRID grid.412505.7, ISNI 0000 0004 0612 5912, Yazd Clinical and Research Center of infertility, , Shahid Sadoughi University of Medical Sciences, ; Yazd, Iran
                [6 ]GRID grid.266865.9, ISNI 0000 0001 2109 4358, Department of Nutrition and Dietetics, , University of North Florida, ; Jacksonville, FL USA
                [7 ]GRID grid.412505.7, ISNI 0000 0004 0612 5912, Department of Biostatistics and Epidemiology, Research Center of Prevention and Epidemiology of Non-Communicable Disease, School of Health, , Shahid Sadoughi University of Medical Sciences, ; Yazd, Iran
                [8 ]GRID grid.411705.6, ISNI 0000 0001 0166 0922, Department of Drug and Food Control, Faculty of Pharmacy, , Tehran University of Medical Sciences, ; Tehran, Iran
                Article
                Publisher ID: 4236
                DOI: 10.1186/s13063-020-04236-y
                PMC ID: 7158024
                PubMed ID: 32290852
                SO-VID: 0d700d27-659c-44ad-a54c-f0a852190a9b
                Copyright © © The Author(s) 2020
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 12 October 2019
                Date accepted : 9 March 2020
                Funding
                Funded by: shahid sadoughi university of medical sciences
                Award ID: 961024
                Funded by: yazd diabetes research center, shahid sadoughi university of medical sciences
                Award ID: 6420
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2020

                ScienceOpen disciplines: Medicine
                Keywords: type 2 diabetes mellitus,synbiotic,gut microbiome,tumor necrosis factor-α ,microrna
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: type 2 diabetes mellitus, synbiotic, gut microbiome, tumor necrosis factor-α , microrna

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