Endocrine Abstracts

Background: Probiotics and omega-3 polyunsaturated fatty acids supplementation (PUFA) have beneficial effect on obesity related disorders in animal models. We have previously shown, on rats with monosodium glutamate-induced obesity, that in take of the combination based on live probiotics and omega-3 PUFA is accompanied by the preventive effect concerning experimental obesity development, lead toinsulin resistance (IR) improvement and more obvious decrease of he paticsteatosis as well as lipid accumulation as compared to probiotic alone. Despite of animal data, randomized placebo-controlled trials (RCT) are still lacking or inconsistent.

In respect to our experimental data, we aimed to carry out place bo-controlled RCT for the efficiency of acombination of multi probiotics with omega-3 PUFA as anadjunction to the standardanti-diabetictherapy on the main metabolic parameters in T2D patients.

Methods: A total of 54 patients met the criteria and were included in double-blind single center RCT, to receive ‘Symbiter-Omega’ (biomass of 14 probiotic bacteria genera Bifidobacterium, Lactobacillus, Lactococcus, Propionibacterium withomega-3 PUFA as single formulation) or placebo for 8-weeks administered as a sachet formulation. The primary main outcome was the change HOMA2-IR (homeostasis model assessment-estimated insulin resistance). This model canbe calculated using the software available at http://www.dtu.ox.ac.uk/homacalculator/index.php. Secondary outcomes were the changes in glycemic control-related parameters, β-cells functionalactivity, anthropomorphic variables and markers of a chronic systemic inflammatory response.

Results: Combineduse of the probiotic mixture with omega-3 PUFA leadstoa significant reduction of HOMA2-IR (P = 0.018) and improvement of insulin sensitivity (% S) (P = 0.010) after 8 weeks of treatment period. Simultaneously were detected lowering of HbA1c from 8.26 ± 0.82 to 7.80 ± 0.86% (P = 0.006). In patients that received placebo insignificant difference for both primary outcomes was found. Additionally, assecondaryoutcomesthefunctionalactivityofβ-cells (% B) was assessed. The intragroup analysis showed a trend to reduce the % B, which was more expressed in the placebo group. In secondary outcome analysis slight significant decrease of bodyweight and BMI as compared to placebo were found. Treatment with omega-3-enrichedprobiotics was accompanied by significant reduction of pro-inflammatorycytokines within intragroupcomparis on during the treatment, namely IL-1β (P = 0.015), TNF-α (P = 0.002), IL-6 (P = 0.001) and IL-8 (P = 0.033) correspondingly.

Conclusion: Probiotic combination with omega-3 PUFA modestly improved insulin resistance and obesity related parameters in patients with type 2 diabetes.