The effect of Bacillus coagulans Unique IS-2 supplementation on plasma amino acid levels and muscle strength in resistance trained males consuming whey protein: a double-blind, placebo-controlled study

Tarik, Mohamad; Bhatia, Nidhi; Goswami, Ravindra; Kandasamy, Devasenathipathy; Roy, A; Chandran, Dinu S; Singh, Archna; Upadhyay, Ashish Datt; Kalaivani, Mani; Neelamraju, Jayanthi; Madempudi, Ratna Sudha; Rajan, Reena

doi:10.1007/s00394-022-02844-9

Cited by 14 publications

(42 citation statements)

References 44 publications

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“…In addition to work utilizing in silico and in vitro studies, several animal toxicity studies have demonstrated the safety of B. subtilis for human use [ 15 , 16 , 17 , 18 , 19 , 20 ]. Clinical trials of B. subtilis and W. coagulans (formally Bacillus coagulans ) strain supplementations have also shown safety and tolerance in humans, as well as digestive and GI health benefits in subjects with inflammatory bowel syndrome [ 21 , 22 , 23 , 24 , 25 ], dyspepsia [ 26 , 27 ], as well as individuals with or without mild symptoms of GI distress [ 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 ]. For example, the B. subtilis strain MB40 has been shown to be safe and support GI health in a randomized, double-blind, placebo-controlled trial of 100 healthy adults [ 17 , 35 ].…”

Section: Introductionmentioning

confidence: 99%

Preclinical Safety Assessment of Bacillus subtilis BS50 for Probiotic and Food Applications

Brutscher¹,

Borgmeier

Garvey³

et al. 2022

Microorganisms

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Despite the commercial rise of probiotics containing Bacillaceae spp., it remains important to assess the safety of each strain before clinical testing. Herein, we performed preclinical analyses to address the safety of Bacillus subtilis BS50. Using in silico analyses, we screened the 4.15 Mbp BS50 genome for genes encoding known Bacillus toxins, secondary metabolites, virulence factors, and antibiotic resistance. We also assessed the effects of BS50 lysates on the viability and permeability of cultured human intestinal epithelial cells (Caco-2). We found that the BS50 genome does not encode any known Bacillus toxins. The BS50 genome contains several gene clusters involved in the biosynthesis of secondary metabolites, but many of these antimicrobial metabolites (e.g., fengycin) are common to Bacillus spp. and may even confer health benefits related to gut microbiota health. BS50 was susceptible to seven of eight commonly prescribed antibiotics, and no antibiotic resistance genes were flanked by the complete mobile genetic elements that could enable a horizontal transfer. In cell culture, BS50 cell lysates did not diminish either Caco-2 viability or monolayer permeability. Altogether, BS50 exhibits a robust preclinical safety profile commensurate with commercial probiotic strains and likely poses no significant health risk to humans.

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Section: Introductionmentioning

confidence: 99%

Preclinical Safety Assessment of Bacillus subtilis BS50 for Probiotic and Food Applications

Brutscher¹,

Borgmeier

Garvey³

et al. 2022

Microorganisms

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“…37,39,40,42,[44][45][46][51][52][53]55,56 Eight studies were conducted in adults with overweight and/or obesity, [42][43][44][45][46]49,50,56 seven in untrained and non-athletic healthy populations, 37,40,41,51,54,55,59 one in resistance-trained individuals, 53 one in individuals with metabolic syndrome and type 2 diabetes 48 or hypertension, 60 one in people with frailty, 38 one in people with low bone mineral density, 58 one in patients with chronic heart failure, 57 one in participants with non-displaced distal radius fracture, 47 one in triathletes 39 and one in volleyball and soccer players. 52 Eleven studies had a treatment duration of 12 weeks, [41][42][43][44][45][46]49,50,54,55,57 three of ...…”

Section: Resultsmentioning

confidence: 99%

“…60 Nine studies assessed muscle mass 37,39,40,42,43,48,54,59,60 and one study assessed appendicular lean mass, 57 and 12 studies assessed total lean mass. 38,41,[44][45][46][49][50][51][52][53]56,58 Body composition assessment was performed via bioelectrical impedance (BIA) in 12 studies 37,[40][41][42][43][48][49][50]52,57,59,60 and dual energy X-ray absorptiometry (DXA) in eight studies, 38,39,[44][45][46]51,53,58 whereas two studies did not report details. 54,56 Three studies assessed handgrip strength, 38,47,57 two bench press 52,…”

Section: Resultsmentioning

confidence: 99%

“…54,56 Three studies assessed handgrip strength, 38,47,57 two bench press 52,53 and deadlift one repetition maximum (1RM) strength, 52,53 one squat 52 and leg press 1RM 53 and one knee extension and flexion peak torque. 55 Eleven studies utilized products containing Lactobacillus species only, [38][39][40][44][45][46][47][48][58][59][60] five Bifidobacterium only, [41][42][43]52,53 three Lactobacillus combined with Bifidobacterium, [54][55][56] three Lactobacillus and Streptococcus 37,51,57 and two Lactobacillus, Bifidobacterium and Lactococcus. 49,50 In terms of dose, five studies supplemented probiotic products with a total of 10 10 colony-forming units (CFU), 45,46,49,50,58 three used 6 × 10 10 CFU, 38,39,55 three had a fixed dose for each substrain, 41,54,…”

Section: Resultsmentioning

confidence: 99%

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Impact of probiotics on muscle mass, muscle strength and lean mass: a systematic review and meta‐analysis of randomized controlled trials

Prokopidis

Giannos

Kirwan

et al. 2022

J cachexia sarcopenia muscle

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Probiotics have shown potential to counteract sarcopenia, although the extent to which they can influence domains of sarcopenia such as muscle mass and strength in humans is unclear. The aim of this systematic review and meta-analysis was to explore the impact of probiotic supplementation on muscle mass, total lean mass and muscle strength in human adults. A literature search of randomized controlled trials (RCTs) was conducted through PubMed, Scopus, Web of Science and Cochrane Library from inception until June 2022. Eligible RCTs compared the effect of probiotic supplementation versus placebo on muscle and total lean mass and global muscle strength (composite score of all muscle strength outcomes) in adults (>18 years). To evaluate the differences between groups, a meta-analysis was conducted using the random effects inverse-variance model by utilizing standardized mean differences. Twenty-four studies were included in the systematic review and meta-analysis exploring the effects of probiotics on muscle mass, total lean mass and global muscle strength. Our main analysis (k = 10) revealed that muscle mass was improved following probiotics compared with placebo (SMD: 0.42, 95% CI: 0.10-0.74, I 2 = 57%, P = 0.009), although no changes were revealed in relation to total lean mass (k = 12; SMD: -0.03, 95% CI: À0.19 -0.13, I 2 = 0%, P = 0.69). Interestingly, a significant increase in global muscle strength was also observed among six RCTs (SMD: 0.69, 95% CI: 0.33-1.06, I 2 = 64%, P = 0.0002). Probiotic supplementation enhances both muscle mass and global muscle strength; however, no beneficial effects were observed in total lean mass. Investigating the physiological mechanisms underpinning different ageing groups and elucidating appropriate probiotic strains for optimal gains in muscle mass and strength are warranted.

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“… 40 Separately, 2 × 10 9 CFU/day supplementation with W. coagulans Unique IS-2 with whey protein for 60 days increased fasting plasma concentrations of amino acids. 41 …”

Section: Discussionmentioning

confidence: 99%

The probiotic Bacillus subtilis BS50 decreases gastrointestinal symptoms in healthy adults: a randomized, double-blind, placebo-controlled trial

Garvey¹,

Mah

Blonquist

et al. 2022

Gut Microbes

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Durable spore-forming probiotics are increasingly formulated into foods, beverages, and dietary supplements. To help meet this demand, the safety and efficacy of daily supplementation of Bacillus subtilis BS50 for 6 weeks was investigated in a randomized, double-blind, placebo-controlled, parallel clinical trial of 76 healthy adults. Before and during supplementation, gastrointestinal symptoms were recorded daily using a multi-symptom questionnaire. Clinical chemistry, hematology, plasma lipids, and intestinal permeability and inflammation markers were measured at baseline and end of study. Compared to placebo, 2 × 10 9 colony-forming units (CFU) BS50 per day increased the proportion of participants showing improvement from baseline to week 6 in the composite score for bloating, burping, and flatulence (47.4% vs. 22.2%), whereby the odds of detecting an improvement were higher with BS50 (OR [95% CI]: 3.2 [1.1, 8.7], p = .024). Analyses of individual gastrointestinal symptoms indicate that BS50 increased the proportion of participants showing an improvement at week 6 compared to placebo for burping (44.7% vs. 22.2%, p = .041) and bloating (31.6% vs. 13.9%, p = .071), without affecting other symptoms. There were no clinically meaningful changes in clinical chemistry, hematology, plasma lipids and intestinal permeability and other inflammation markers. In conclusion, the results suggest that dietary supplementation of 2 × 10 9 CFU Bacillus subtilis BS50 per day is a well-tolerated and safe strategy to alleviate gas-related gastrointestinal symptoms in healthy adults. Abbreviations AE adverse event; BHD bowel habits diary; BMI body mass index; BSS Bristol Stool Scale; CFU colony-forming unit; CRP C-reactive protein; FGID functional gastrointestinal disorder; GI gastrointestinal; GITQ Gastrointestinal Tolerance Questionnaire; GLP-1 glucagon-like peptide 1; GSRS Gastrointestinal Symptom Rating Scale; HDL-C high-density lipoprotein-cholesterol; IBS irritable bowel syndrome; IL-10 interleukin-10; ITT intent-to-treat; LBP lipopolysaccharide binding protein; LDL-C low-density lipoprotein-cholesterol; PP per protocol; PYY peptide YY; TG triglyceride; total-C total cholesterol

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The effect of Bacillus coagulans Unique IS-2 supplementation on plasma amino acid levels and muscle strength in resistance trained males consuming whey protein: a double-blind, placebo-controlled study

Cited by 14 publications

References 44 publications

Preclinical Safety Assessment of Bacillus subtilis BS50 for Probiotic and Food Applications

Preclinical Safety Assessment of Bacillus subtilis BS50 for Probiotic and Food Applications

Impact of probiotics on muscle mass, muscle strength and lean mass: a systematic review and meta‐analysis of randomized controlled trials

The probiotic Bacillus subtilis BS50 decreases gastrointestinal symptoms in healthy adults: a randomized, double-blind, placebo-controlled trial

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