Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: A randomized control trial

Jones, Mitchell L.; Martoni, Christopher; Pietro, Erminia Di; Simon, Ryan; Prakash, Satya

doi:10.1016/j.yrtph.2012.04.003

Cited by 56 publications

(48 citation statements)

References 21 publications

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“…Changes in body weight was not significant in 6 studies. [23][24][25]31,32,35 However, it reduced significantly in the intervention group in 1 study 30 and in both intervention and control groups in another study. 34 Nutrition intake was measured in 3 studies, 23,32,33 which showed no significant changes in intervention or control group.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 89%

“…24 Four studies reported that participants did not know the difference between intervention and control. 23,30,32,33 Six studies reported the similarity in intervention and placebo products, 24,25,[31][32][33][34] and 4 studies reported blinding of treatment allocation and measurements. 23,24,30,34 All included articles had a Rosendal score >50%, with the smallest score of 53% for the study by Kawase et al 35 and the highest score of 85% for the study by Jones et al 31 ( Table S1 in the online-only Data Supplement).…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…All studies reported changes in SBP and DBP, except for the study by Kawase et al, 35 which only reported changes in SBP (n=543 for SBP analysis; n= 522 for DBP analysis). Of the 9 studies, 3 included healthy participants, 30,32,33,35 2 included patients with hypercholesterolemia, 31 1 included patients with hypertension, 24 1 included overweight and obese subjects, 23 and 1 included patients with metabolic syndrome. 34 One study reported a significant reduction of body mass index (BMI) after consuming probiotics, 34 and another reported a significant increase in BMI.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

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Effect of Probiotics on Blood Pressure

et al. 2014

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Abstract-Previous human clinical trials have shown that probiotic consumption may improve blood pressure (BP) control.The aim of the present systematic review was to clarify the effects of probiotics on BP using a meta-analysis of randomized, controlled trials. PubMed, Scopus, Cochrane Library (Central), Physiotherapy Evidence Database, and Clinicaltrial.gov databases were searched until January 2014 to identify eligible articles. Meta-analysis using a random-effects model was chosen to analyze the impact of combined trials. Nine trials were included. Probiotic consumption significantly changed systolic BP by −3.56 mm Hg (95% confidence interval, −6.46 to −0.66) and diastolic BP by −2.38 mm Hg (95% confidence interval, −2.38 to −0.93) compared with control groups. A greater reduction was found with multiple as compared with single species of probiotics, for both systolic and diastolic BP. Subgroup analysis of trials with baseline BP ≥130/85 mm Hg compared with <130/85 mm Hg found a more significant improvement in diastolic BP. Duration of intervention <8 weeks did not result in a significant reduction in systolic or diastolic BP. Furthermore, subgroup analysis of trials with daily dose of probiotics <10 11 colony-forming units did not result in a significant meta-analysis effect. The present meta-analysis suggests that consuming probiotics may improve BP by a modest degree, with a potentially greater effect when baseline BP is elevated, multiple species of probiotics are consumed, the duration of intervention is ≥8 weeks, or daily consumption dose is ≥10 The online-only Data Supplement is available with this article at http://hyper.ahajournals.org/lookup/suppl

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Section: Characteristics Of Included Studiesmentioning

confidence: 89%

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

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Effect of Probiotics on Blood Pressure

et al. 2014

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“…Many studies have assessed the effect of probiotics on metabolic profiles in people [39], and several systematic reviews and meta-analyses have shown that probiotics had an effect on diabetes, but their pooled results showed a lack of accordance and their included studies were uncomprehensive, which could lead to a possibility of unreliable results and conclusions [27][28][29]. Thus, we performed this meta-analysis demonstrate the effects of probiotics for T2DM and other MS patients in reducing the level of fasting glucose, insulin and HbA 1c .…”

Section: Discussionmentioning

confidence: 99%

Multiple effects of probiotics on different types of diabetes: a systematic review and meta-analysis of randomized, placebo-controlled trials

Wang

Juan

et al. 2017

Journal of Pediatric Endocrinology and Metabolism

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Background: A systematic review and meta-analysis was designed to evaluate the effect of probiotics on diabetes and its associated risk factors. Methods: We systematically searched the Cochrane Library, PubMed, EMBASE and Web of Science to June 2016. We also hand-searched the citation lists of included studies and previously identified systematic reviews to identify further relevant trials. Our primary outcome variables included glucose, glycated hemoglobin (HbA 1c ) and insulin. The pooled standardized mean difference was used to compare the effect between the probiotics and controlled groups, and the pooled standardized mean difference effect size with a 95% confidence interval (CI) was estimated using a random-effect model. Heterogeneity was assessed with Cochran's Q and Higgins I 2 tests. Two reviewers assessed trial quality and extracted data independently. The analysis and bias for each included study was performed and assessed using Review Manager 5.2. Results: Eighteen randomized, placebo-controlled studies (n = 1056 participants, 527 consuming probiotics, 529 not consuming probiotics) were included for analysis. Comparing the probiotics groups with the control groups, there were statistically significant pooled standardized

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“…18 Furthermore, the clinical safety and tolerability of L. reuteri NCIMB 30242 has been confirmed in yogurt 27 and capsule formulations. 28 However, it was not known if similar efficacy would be seen with a capsule format, if additional efficacy would be seen over a longer interventional period, or if delivery of the BSH-active strain would result in increased circulating deconjugated bile acids or reduced absorption of non-cholesterol sterols. Accordingly, the main objective of the present study was to assess the cholesterol-lowering clinical efficacy and to investigate the mechanism of action of BSH-active L. reuteri NCIMB 30242 supplement capsules over a 9-week intervention period in a randomized controlled trial.…”

Section: Introductionmentioning

confidence: 99%

Cholesterol lowering and inhibition of sterol absorption by Lactobacillus reuteri NCIMB 30242: a randomized controlled trial

2012

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BACKGROUND/OBJECTIVES:The percentage of hypercholesterolemic individuals not reaching their LDL-cholesterol (LDL-C) goal remains high and additional therapeutic strategies should be evaluated. The objective of this study was to evaluate the cholesterollowering efficacy and mechanism of action of bile salt hydrolase-active Lactobacillus reuteri NCIMB 30242 capsules in hypercholesterolemic adults. SUBJECTS/METHODS: A total of 127 subjects completed a randomized, double-blind, placebo-controlled, parallel-arm, multicenter study. Subjects were randomized to consume L. reuteri NCIMB 30242 capsules or placebo capsules over a 9-week intervention period. The primary outcome was LDL-C relative to placebo at the study end point. RESULTS: L. reuteri NCIMB 30242 capsules reduced LDL-C by 11.64% (Po0.001), total cholesterol by 9.14%, (Po0.001), non-HDLcholesterol (non-HDL-C) by 11.30% (Po0.001) and apoB-100 by 8.41% (P ¼ 0.002) relative to placebo. The ratios of LDL-C/HDLcholesterol (HDL-C) and apoB-100/apoA-1 were reduced by 13.39% (P ¼ 0.006) and 9.00% (P ¼ 0.026), respectively, relative to placebo. Triglycerides and HDL-C were unchanged. High-sensitivity C-reactive protein and fibrinogen were reduced by 1.05 mg/l (P ¼ 0.005) and 14.25% (P ¼ 0.004) relative to placebo, respectively. Mean plasma deconjugated bile acids were increased by 1.00 mmol/l (P ¼ 0.025) relative to placebo, whereas plasma campesterol, sitosterol and stigmasterol were decreased by 41.5%, 34.2% and 40.7%, respectively. CONCLUSIONS: The present results suggest that the deconjugation of intraluminal bile acids results in reduced absorption of non-cholesterol sterols and indicate that L. reuteri NCIMB 30242 capsules may be useful as an adjunctive therapy for treating hypercholesterolemia.

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Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: A randomized control trial

Cited by 56 publications

References 21 publications

Effect of Probiotics on Blood Pressure

Effect of Probiotics on Blood Pressure

Multiple effects of probiotics on different types of diabetes: a systematic review and meta-analysis of randomized, placebo-controlled trials

Cholesterol lowering and inhibition of sterol absorption by Lactobacillus reuteri NCIMB 30242: a randomized controlled trial

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