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Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naive T2DM patients: a randomized clinical trial.

ABSTRACT: The present randomized clinical trial characterized the beneficial effects of a multi-strain probiotics supplementation on improving circulating endotoxin levels (primary endpoint) and other cardiometabolic biomarkers (secondary endpoint) in patients with T2DM.A total of 78 adult Saudi T2DM patients (naïve and without co-morbidities) participated in this clinical trial and were randomized to receive twice daily placebo or probiotics [(2.5 × 109 cfu/g) containing the following bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 (Ecologic®Barrier)] in a double-blind manner for 12 weeks. Anthropometrics and cardiometabolic profiles were obtained at baseline and after 12/13 weeks of treatment.After 12/13 weeks of intervention and using intention-to-treat analysis, no difference was noted in endotoxin levels between groups [Placebo - 9.5% vs. Probiotics - 52.2%; (CI - 0.05 to 0.36; p = 0.15)]. Compared with the placebo group however, participants in the probiotics groups had a significant but modest improvement in WHR [Placebo 0.0% vs. Probiotics 1.11%; (CI - 0.12 to - 0.01; p = 0.02)] as well as a clinically significant improvement in HOMA-IR [Placebo - 12.2% vs. Probiotics - 60.4%; (CI - 0.34 to - 0.01; p = 0.04)].Using a multi-strain probiotic supplement daily for 12/13 weeks significantly improved HOMA-IR and modestly reduced abdominal adiposity among medication naïve T2DM patients.ClinicalTrials.gov Identifier: NCT01765517 , Registered January 10, 2013.

SUBMITTER: Sabico S

PROVIDER: S-EPMC5725828 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naïve T2DM patients: a randomized clinical trial.

Sabico Shaun S Al-Mashharawi Ayah A Al-Daghri Nasser M NM Yakout Sobhy S Alnaami Abdullah M AM Alokail Majed S MS McTernan Philip G PG

Journal of translational medicine 20171211 1

<h4>Background</h4>The present randomized clinical trial characterized the beneficial effects of a multi-strain probiotics supplementation on improving circulating endotoxin levels (primary endpoint) and other cardiometabolic biomarkers (secondary endpoint) in patients with T2DM.<h4>Methods</h4>A total of 78 adult Saudi T2DM patients (naïve and without co-morbidities) participated in this clinical trial and were randomized to receive twice daily placebo or probiotics [(2.5 × 10<sup>9</sup> cfu/g ...[more]

PMID: 29228964

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Project description:BackgroundGrowing evidence has shown that obesity is associated with poor neurocognitive outcomes. Bariatric surgery has been shown to be an effective intervention for morbid obesity and can result in improvement of many co-morbid medical conditions that are associated with cognitive dysfunction. The effects of bariatric surgery on cognition are unknown.MethodsWe performed a prospective study total of 150 subjects (109 bariatric surgery patients enrolled in the Longitudinal Assessment of Bariatric Surgery project and 41 obese control subjects who had not undergone bariatric surgery). These 150 subjects completed a cognitive evaluation at baseline and at 12 weeks of follow-up. The demographic, medical, and psychosocial information was also collected to elucidate the possible mechanisms of change.ResultsMany bariatric surgery patients exhibited impaired performance on cognitive testing at baseline (range 4.6-23.9%). However, the surgery patients were no more likely to exhibit a decline on ?2 cognitive tests at 12 weeks of follow-up than were the obese controls [12.84% versus 23.26%; chi-square (1) = 2.51, P = .11]. Group comparisons using repeated measures multivariate analysis of variance showed that the surgery patients had improved memory performance at 12 weeks of follow-up [? = .86, F(4, 147) = 5.88, P <.001]; however, the memory performance of the obese controls had actually declined. Regression analyses showed that the surgery patients without hypertension had better short delay recall at 12 weeks than those with hypertension [? = .31, P = .005], although the other demographic and medical variables were largely unrelated to the test performance.ConclusionThe present results suggest that cognitive impairment is common in bariatric surgery patients, although these deficits might be at least partly reversible. Future studies are needed to clarify the underlying mechanisms, in particular, longitudinal studies using neuroimaging and blood markers.

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Dataset Information

Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naive T2DM patients: a randomized clinical trial.

Publications

Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naïve T2DM patients: a randomized clinical trial.

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