Key result
Randomized crossover trial evaluates Lactobacillus reuteri V3401 for lowering plasma LPS in metabolic syndrome.
RCT
Randomized crossover
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BACKGROUND: Obesity is characterized by increased fat mass and is associated with the development of insulin resistance syndrome (IRS), usually known as metabolic syndrome. The alteration of the intestinal microbiota composition has a role in the development of IRS associated with obesity, and probiotics, which are live microorganisms that confer a health benefit to the host, contribute to restore intestinal microbiota homeostasis and lower peripheral tissue insulin resistance. We aim to evaluate the effects of the probiotic strain Lactobacillus reuteri (L. reuteri) V3401 on the composition of intestinal microbiota, markers of insulin resistance and biomarkers of inflammation, cardiovascular risk, and hepatic steatosis in patients with overweight and obesity exhibiting IRS. METHODS/DESIGN: colony-forming units of L. reuteri V3401. The study will consist of two intervention periods of 12 weeks separated by a washout period of 6 weeks and preceded by another washout period of 2 weeks. The primary outcome will be the change in plasma lipopolysaccharide (LPS) levels at 12 weeks. Secondary outcomes will include anthropometric parameters, lipid profile, glucose metabolism, microbiota composition, hepatic steatosis, and inflammatory and cardiovascular biomarkers. Blood and stool samples will be collected at baseline, at the midpoint (only stool samples) and immediately after each intervention period. Luminex technology will be used to measure interleukins. For statistical analysis, a mixed ANOVA model will be employed to calculate changes in the outcome variables. DISCUSSION: This is the first time that L. reuteri V3401 will be evaluated in patients with IRS. Therefore, this study will provide valuable scientific information about the effects of this strain in metabolic syndrome patients. TRIAL REGISTRATION: The trial has been retrospectively registered in ClinicalTrials.gov on the 23rd November 2016 (ID: NCT02972567 ), during the recruitment phase.
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Tenorio-Jiménez et al. (2018) conducted an RCT in Overweight and obesity with metabolic syndrome (insulin resistance syndrome). Lactobacillus reuteri V3401 was evaluated on Change in plasma lipopolysaccharide (LPS) levels at 12 weeks. Lactobacillus reuteri V3401 is being evaluated in a crossover trial of two 12-week periods for its effect on plasma LPS levels in obese adults with metabolic syndrome (protocol, no results reported).
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