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

Year: 2018

Journal: Clinical Nutrition

Authors: Shaun Sabico Ayah Al-Mashharawi Nasser M Al-Daghri Kaiser Wani Osama E. Amer Danish S. Hussain Mohammed Ghouse Ahmed Ansari Mohammad S. Masoud Majed S. Alokail Philip G. McTernan


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 naïve T2DM (n ¼ 30; 12 males and 18 females) were randomly allocated to receive twice daily placebo or 2.5  109 cfu/g of Ecologic®Barrier (multi-strain probiotics; n ¼ 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-a), 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-a (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.

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Clinical Nutrition