PMID- 30170781 OWN - NLM STAT- MEDLINE DCOM- 20200622 LR - 20200622 IS - 1532-1983 (Electronic) IS - 0261-5614 (Linking) VI - 38 IP - 4 DP - 2019 Aug TI - Effects of a 6-month multi-strain probiotics supplementation in endotoxemic, inflammatory and cardiometabolic status of T2DM patients: A randomized, double-blind, placebo-controlled trial. PG - 1561-1569 LID - S0261-5614(18)31351-7 [pii] LID - 10.1016/j.clnu.2018.08.009 [doi] AB - OBJECTIVE: The aim of this trial was to characterize the beneficial effects of probiotics on decreasing endotoxin levels and other cardiometabolic parameters in Arab patients with type 2 diabetes mellitus (T2DM). METHODS: Saudi adults with naive T2DM (n = 30; 12 males and 18 females) were randomly allocated to receive twice daily placebo or 2.5 x 10(9) cfu/g of Ecologic((R))Barrier (multi-strain probiotics; n = 31; 14 males and 17 females) in a double-blind manner over a 6 month period, respectively. Anthropometrics were measured and fasting blood samples were collected to analyze endotoxin, glycemic parameters [glucose, insulin, c-peptide and homeostasis model assessment for insulin resistance (HOMA-IR)], lipids [triglycerides, total cholesterol, low and high-density lipoprotein (LDL and HDL, respectively) cholesterol and total/HDL-cholesterol ratio], inflammatory markers [tumor-necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6) and C-reactive protein (CRP)] and adipocytokines [leptin, adiponectin and resistin] at baseline and after 3 and 6 months of intervention. RESULTS: Multi-strain probiotics supplementation for 6 months caused a significant decrease in circulating levels of endotoxin by almost 70% over 6 months, as well as glucose (38%), insulin (38%), HOMA-IR (64%), triglycerides (48%), total cholesterol (19%), total/HDL-cholesterol ratio (19%), TNF-alpha (67%), IL-6 (77%), CRP (53%), resistin (53%), and a significant increase in adiponectin (72%) as compared with baseline. Only HOMA-IR had a clinically significant reduction (-3.4, 64.2%) in the probiotics group as compared to placebo group at all time points. No other clinically significant changes were observed between the probiotic or placebo group at 3 and 6 months in other markers. CONCLUSION: Multi-strain probiotic supplementation over 6 months as a monotherapy significantly decreased HOMA-IR in T2DM patients, with the probiotic treatment group highlighting reduced inflammation and improved cardiometabolic profile. As such, multi-strain probiotics is a promising adjuvant anti-diabetes therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01765517. CI - Copyright (c) 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Sabico, Shaun AU - Sabico S AD - Warwick Medical School, Division of Biomedical Sciences, University of Warwick, UHCW Trust, Clifford Bridge Road, Walsgrave, Coventry, CV2 2DX, UK; Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. Electronic address: s.l.sabico@warwick.ac.uk. FAU - Al-Mashharawi, Ayah AU - Al-Mashharawi A AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - Al-Daghri, Nasser M AU - Al-Daghri NM AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - Wani, Kaiser AU - Wani K AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - Amer, Osama E AU - Amer OE AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - Hussain, Danish S AU - Hussain DS AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - Ahmed Ansari, Mohammed Ghouse AU - Ahmed Ansari MG AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - Masoud, Mohammad S AU - Masoud MS AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - Alokail, Majed S AU - Alokail MS AD - Prince Mutaib bin Abdullah Chair for Biomarkers of Osteoporosis, Biochemistry Department, College of Science, King Saud University, Riyadh, 11451, Saudi Arabia. FAU - McTernan, Philip G AU - McTernan PG AD - School of Science and Technology, Department of Biosciences, Nottingham Trent University, Nottingham, NG1 8NS, UK. Electronic address: philip.mcTernan@ntu.ac.uk. LA - eng SI - ClinicalTrials.gov/NCT01765517 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180817 PL - England TA - Clin Nutr JT - Clinical nutrition (Edinburgh, Scotland) JID - 8309603 RN - 0 (Adipokines) RN - 0 (Blood Glucose) RN - 0 (Endotoxins) RN - 0 (Insulin) RN - 0 (Lipids) RN - 0 (Placebos) SB - IM MH - Adipokines/blood MH - Blood Glucose/*drug effects MH - *Diabetes Mellitus, Type 2/diet therapy/metabolism MH - Double-Blind Method MH - Endotoxins/*blood MH - Female MH - Humans MH - Inflammation/*blood MH - Insulin/blood MH - Insulin Resistance/physiology MH - Lipids/blood MH - Male MH - Placebos MH - *Probiotics/administration & dosage/pharmacology/therapeutic use OTO - NOTNLM OT - Endotoxin OT - Probiotics OT - Type 2 diabetes mellitus EDAT- 2018/09/02 06:00 MHDA- 2020/06/23 06:00 CRDT- 2018/09/02 06:00 PHST- 2017/11/15 00:00 [received] PHST- 2018/08/08 00:00 [revised] PHST- 2018/08/10 00:00 [accepted] PHST- 2018/09/02 06:00 [pubmed] PHST- 2020/06/23 06:00 [medline] PHST- 2018/09/02 06:00 [entrez] AID - S0261-5614(18)31351-7 [pii] AID - 10.1016/j.clnu.2018.08.009 [doi] PST - ppublish SO - Clin Nutr. 2019 Aug;38(4):1561-1569. doi: 10.1016/j.clnu.2018.08.009. Epub 2018 Aug 17.