Data from a study with type-2 diabetics revealed that six months of supplementation with the multi-strain formulation also led to significant reductions in markers of inflammation like C-reactive Protein (CRP), while circulating levels of endotoxin, a measure of gut barrier function, were reduced by an impressive 70%.
The study was performed in Saudi Arabia and is said to be the first clinical trial to study probiotics in diabetics in their region. “The present study is also one of the longest randomized controlled trials to demonstrate the beneficial effects of a multi-strain probiotic supplementation in improving the [insulin resistance] of [type 2 diabetes mellitus] patients,” wrote the researchers in Clinical Nutrition.
“Findings from the study offer important information that will expand our current understanding on how multi-strain probiotic supplements work in the diabetic population arising from a relatively homogenous and understudied ethnic population,” wrote researchers, from the University of Warwick (UK), King Saud University (Saudi Arabia), and Nottingham Trent University (UK).
“The findings also shed light on the challenges of conducting randomized clinical trials in this area of the world where such studies that offer high level of evidence are still evolving and would require greater input and participation from the general population. This study nonetheless recommends the use of multiple-strain probiotics as a supplemental therapy in subjects with T2DM [type 2 diabetes mellitus].”
Commenting independently on the study’s findings, the IPA scientific committee told NutraIngredients-USA that the study fits in a growing body of documentation that indicates that selected probiotic strains and combinations of strains may beneficially influence factors collectively forming metabolic syndrome.
“The study is, with 96 participants, one of the larger studies in this area; this despite the fact that, as the authors acknowledge, there was a higher dropout rate than anticipated,” stated the IPA committee. “Also the differences between the groups at base line, are unfortunate, but cannot always be avoided.
“It is unfortunate that the product is not fully specified. The strains and dose are mentioned. However, the authors, and in fact the manufacturer, fail to mention their ratio. With eight strains in the product, this is relevant to know. Nevertheless, this does not change anything to the results.
“The results remain very encouraging,” concluded the IPA scientific committee.
The randomized, double-blind, placebo-controlled trial included 30 diabetics who were randomly assigned to receive either placebo or the multi-strain probiotic (total daily dose of five billion CFUs) for six month. The study used Winclove’s Ecologic Barrier product, which contains Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and L. lactis W58.
Results showed that, compared to baseline, the probiotic group experienced significant reductions in glucose (38%), insulin (38%), and insulin resistance (the homeostasis model assessment for insulin resistance (HOMA-IR), 64%).
Blood lipids were also improved, with triglycerides and total cholesterol decreasing by 48% and 19%, respectively. The ratio of total to HDL-cholesterol ratio also decreased over six months by 19%.
Reductions in markers of inflammation were found for TNF-alpha (67%), interleukin-6 (77%), and C-reactive protein (53%).
Finally, levels of adipocytokines were also impacted. Resistin decreased by 53%, while adiponectin increased by 72%.
Despite all of these improvements compared to baseline, the only statistical significant reduction compared to placebo was for HOMA-IR, which decreased by a “clinically significant” 64.2%.
“As HOMA-IR is intricately linked to most of the cardiometabolic indices measured, the clinically significant improvement suggests that probiotics supplementation do confer beneficial effects when consumed by the T2DM population,” wrote the researchers.
“Clinical trials on probiotic supplementation in the Arabic T2DM population has never been performed previously. This is important since the gut microbiome is highly affected not only by the health status of the individual, but more so by geography and ethnicity. Findings of the present study therefore add value to the current literature in terms of ethnic-specific effects of probiotics supplementation among patients with T2DM,” they added.
Source: Clinical Nutrition
Published online ahead of print, doi: 10.1016/j.clnu.2018.08.009
“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”
Authors: S. Sabico et al.