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      Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study

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          Abstract

          Background

          Role of multi-strain probiotic formulations in the management of type 2 diabetes mellitus (T2DM) has rarely been reported. In the present study, the effects of the probiotic formulation, UB0316 ( L. salivarius UBLS22, L. casei UBLC42, L. plantarum UBLP40, L. acidophilus UBLA34, B. breve UBBr01, B. coagulans Unique IS2, 5 billion CFU each and fructo-oligosaccharides, 100 mg) in patients with T2DM were assessed.

          Methods

          A total of 79 eligible subjects (18–65 years, on stable metformin therapy) were randomly assigned to receive UB0316 or placebo, twice-a-day for 12 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c), secondary were assessment of blood glucose levels, HOMA-IR (homeostatic model assessment of insulin resistance), insulin, body weight, and blood lipids. Quality of life, vital signs, physical investigations, safety and Physician/Subject’s Global assessment were also evaluated.

          Results

          Twelve week multi-strain probiotic (UB0316) supplementation significantly reduced HbA1c (7.70 ± 0.79%; p = 0.0023) and weight (67.00 ± 8.82 kg; p < 0.001) as compared to placebo (HbA1c: 8.30 ± 1.35%; weight: 67.60 ± 9.46 kg). The changes recorded in fasting blood glucose (FBG), HOMA-IR, insulin, TC, TG, HDL, and LDL levels were however not significantly altered as compared to placebo. No severe adverse events, abnormal vital and physical signs were reported. The quality of life of T2DM was significantly improved.

          Conclusions

          UB0316 significantly improved glycemic control as indicated by the decrease in HbA1c levels. There was also a significant decrease in weight in the probiotic treated subjects as compared to placebo.

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          Most cited references23

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          Metabolic effects of Lactobacillus reuteri DSM 17938 in people with type 2 diabetes: A randomized controlled trial.

          To investigate the metabolic effects of 12-week oral supplementation with Lactobacillus reuteri DSM 17938 in patients with type 2 diabetes on insulin therapy.
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            The importance of weight management in type 2 diabetes mellitus

            Background The obesity epidemic is driving the increased prevalence of type 2 diabetes mellitus (T2DM), and the vast majority of patients with T2DM are overweight or obese. Excess body weight is associated with the risk of cardiometabolic complications, which are major causes of morbidity and mortality in T2DM. Aims To review evidence about effects of weight loss in pre-diabetes and established T2DM. Results In prediabetes, weight loss has been shown to delay the onset or decrease the risk of T2DM, while in established T2DM weight loss has been shown to improve glycaemic control, with severe calorie restriction even reversing the progression of T2DM. Observational studies support the reduction in cardiovascular risk factors following weight loss in patients with T2DM. However, data from the randomised Look AHEAD trial revealed intensive weight loss interventions did not reduce the rate of cardiovascular events in overweight or obese adults with T2DM, and secondary analyses of other large cardiovascular outcomes trials have also been inconclusive. However, besides cardiovascular risk, other documented benefits of weight loss in T2DM include improvements in quality of life, mobility, and physical and sexual function. Conclusions Physicians should encourage weight loss in all overweight patients with or at risk of T2DM, and should consider the impact on weight when choosing the most appropriate glucose-lowering therapies for these patients.
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              Dietary Alteration of the Gut Microbiome and Its Impact on Weight and Fat Mass: A Systematic Review and Meta-Analysis

              Dietary alteration of the gut microbiome is an important target in the treatment of obesity. Animal and human studies have shown bidirectional weight modulation based on the probiotic formulation used. In this study, we systematically reviewed the literature and performed a meta-analysis to assess the impact of prebiotics, probiotics and synbiotics on body weight, body mass index (BMI) and fat mass in adult human subjects. We searched Medline (PubMed), Embase, the Cochrane Library and the Web of Science to identify 4721 articles, of which 41 were subjected to full-text screening, yielding 21 included studies with 33 study arms. Probiotic use was associated with significant decreases in BMI, weight and fat mass. Studies of subjects consuming prebiotics demonstrated a significant reduction in body weight, whereas synbiotics did not show an effect. Overall, when the utilization of gut microbiome-modulating dietary agents (prebiotic/probiotic/synbiotic) was compared to placebo, there were significant decreases in BMI, weight and fat mass. In summary, dietary agents for the modulation of the gut microbiome are essential tools in the treatment of obesity and can lead to significant decreases in BMI, weight and fat mass. Further studies are needed to identify the ideal dose and duration of supplementation and to assess the durability of this effect.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Project administrationRole: Writing – review & editing
                Role: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Project administrationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                13 November 2019
                2019
                : 14
                : 11
                : e0225168
                Affiliations
                [1 ] Centre for Research & Development, Unique Biotech Ltd., Alexandria Knowledge Park, Hyderabad, Telangana, India
                [2 ] Life Veda Treatment and Research Centre, Worli, Mumbai, India
                [3 ] Nanal Clinic, Anand Bhuvan, Gore wadi, Mahim (W), Mumbai, India
                Universidad Miguel Hernandez de Elche, SPAIN
                Author notes

                Competing Interests: RSM, JJA and JN are employed by Unique Biotech Limited, India, which is a manufacturer of probiotics and AT and SN are from Life Veda Treatment and Research Centre and Nanal Clinic, Mumbai, India. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0003-1819-722X
                http://orcid.org/0000-0002-1142-8630
                Article
                PONE-D-19-07135
                10.1371/journal.pone.0225168
                6853318
                31721790
                c0b2ec00-9529-4aa7-96d3-b3d22aa04c6f
                © 2019 Madempudi et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 20 April 2019
                : 29 October 2019
                Page count
                Figures: 3, Tables: 3, Pages: 16
                Funding
                This work was funded by Unique Biotech Limited, Hyderabad, India. The funder provided support in the form of salaries [RSM, JJA and JN] and compensation [AT and SN] for authors, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’.
                Categories
                Research Article
                Biology and Life Sciences
                Microbiology
                Probiotics
                Medicine and health sciences
                Diagnostic medicine
                Diabetes diagnosis and management
                HbA1c
                Biology and life sciences
                Biochemistry
                Proteins
                Hemoglobin
                HbA1c
                Medicine and Health Sciences
                Endocrinology
                Diabetic Endocrinology
                Insulin
                Biology and Life Sciences
                Biochemistry
                Hormones
                Insulin
                Biology and Life Sciences
                Anatomy
                Body Fluids
                Blood
                Blood Sugar
                Medicine and Health Sciences
                Anatomy
                Body Fluids
                Blood
                Blood Sugar
                Biology and Life Sciences
                Physiology
                Body Fluids
                Blood
                Blood Sugar
                Medicine and Health Sciences
                Physiology
                Body Fluids
                Blood
                Blood Sugar
                Medicine and Health Sciences
                Health Care
                Quality of Life
                Medicine and Health Sciences
                Endocrinology
                Endocrine Disorders
                Diabetes Mellitus
                Type 2 Diabetes
                Medicine and Health Sciences
                Metabolic Disorders
                Diabetes Mellitus
                Type 2 Diabetes
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Biology and Life Sciences
                Biochemistry
                Proteins
                Lipoproteins
                Custom metadata
                All relevant data are within the manuscript and its Supporting Information files.

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