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Effect of an Immune-Boosting, Antioxidant and Anti-Inflammatory Food Supplement in Hospitalized COVID-19 Patients: A Prospective Randomized Pilot Study.
Reino-Gelardo, S, Palop-Cervera, M, Aparisi-Valero, N, Espinosa-San Miguel, I, Lozano-Rodríguez, N, Llop-Furquet, G, Sanchis-Artero, L, Cortés-Castell, E, Rizo-Baeza, M, Cortés-Rizo, X
Nutrients. 2023;15(7)
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Coronavirus Disease 2019 (COVID-19), has spread worldwide, reaching pandemic proportions. The symptoms caused by COVID-19 disease are nonspecific and may range from asymptomatic to severe pneumonia and death. The aim of this study was to evaluate the potential effect of a food supplement (probiotics, prebiotics, vitamin D, zinc and selenium) in patients admitted with COVID-19. This study was a prospective, randomised, non-blinded clinical trial. A total of 162 patients were enrolled at Sagunto Hospital, 42.0% of whom were women. Participants were assigned to one of the two groups: probiotic or control group. Results showed that higher mortality was found in men, older patients and those with severe radiological involvement. Furthermore, administration of the food supplement product Gasteel Plus®, as an adjuvant to the treatment established in the hospital for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated pneumonia, reduced the duration of digestive symptoms and hospital stay in patients with mild–moderate pulmonary involvement. Authors conclude that their findings demonstrate the importance of considering the use of the food supplement under review in the prevention and treatment of SARS-CoV-2, including severe cases, which showed no side effects.
Abstract
BACKGROUND COVID-19 disease is a serious global health problem. Few treatments have been shown to reduce mortality and accelerate time to recovery. The aim of this study was to evaluate the potential effect of a food supplement (probiotics, prebiotics, vitamin D, zinc and selenium) in patients admitted with COVID-19. METHODS A prospective randomized non-blinded clinical trial was conducted in a sample of 162 hospitalized patients diagnosed with COVID-19 recruited over eight months. All patients received standard treatment, but the intervention group (n = 67) was given one food supplement stick daily during their admission. After collecting the study variables, a statistical analysis was performed comparing the intervention and control groups and a multivariate analysis controlling for variables that could act as confounding factors. RESULTS ROC curve analysis with an area under the curve (AUC) value of 0.840 (p < 0.001; 95%CI: 0.741-0.939) of the food supplement administration vs. recovery indicated good predictive ability. Moreover, the intervention group had a shorter duration of digestive symptoms compared with the control group: 2.6 ± 1.3 vs. 4.3 ± 2.2 days (p = 0.001); patients with non-severe disease on chest X-ray had shorter hospital stays: 8.1 ± 3.9 vs. 11.6 ± 7.4 days (p = 0.007). CONCLUSIONS In this trial, the administration of a food supplement (Gasteel Plus®) was shown to be a protective factor in the group of patients with severe COVID-19 and allowed early recovery from digestive symptoms and a shorter hospital stay in patients with a normal-mild-moderate chest X-ray at admission (ClinicalTrials.gov number, NCT04666116).
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Energy Availability and Nutritional Intake during Different Training Phases of Wheelchair Athletes.
Hertig-Godeschalk, A, Ruettimann, B, Valido, E, Glisic, M, Stoyanov, J, Flueck, JL
Nutrients. 2023;15(11)
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To maintain a long-term and successful career, elite athletes try to prevent health problems and maximize training adaptations. This includes not only managing training volume and intensity, along with recovery, but also tailoring nutrition to individual needs. The aim of this study was to assess dietary intake, energy availability (EA), and blood biochemical parameters at four consecutive time points during the pre-competition and competition phases in elite wheelchair athletes participating in a pilot feasibility study. This study was a secondary analysis of a randomised controlled trial. In the main study the participants were athletes who received either daily probiotic or prebiotic supplementation for four weeks, followed by a four-week washout period, and another four weeks of daily supplementation with another supplement. Results showed that: - neither EA nor energy intake (EI) displayed significant differences across the various time points. - all athletes experienced low EA for at least one day, indicating how tough fuelling is for elite athletes. - daily macronutrient intake and timing were frequently suboptimal, with athletes not adjusting EI to accommodate higher training loads. Authors concluded that their findings highlight the need for specific nutritional guidelines tailored to wheelchair athletes, as well as the importance of continuous education and guidance from qualified sports nutritionists.
Abstract
Optimizing nutritional intake and timing helps athletes to improve performance and long-term health. Different training phases can require varying nutritional needs. In this study, we conducted a descriptive assessment of dietary intake, energy availability (EA), and blood biochemical parameters in elite wheelchair athletes during distinct training phases. Data analyzed in this study were collected as part of a randomized controlled crossover trial exploring the feasibility of probiotics and prebiotic supplementation. Data were obtained from consecutive three-day diaries and blood samples, both collected at four different time points across four consecutive months. We included 14 athletes (mean (standard deviation) age 34 (9) years, eight females, and six males) active in different wheelchair sports. The mean daily nutritional intake (g/kg body mass) for females and males was 2.7 (0.9) and 4.0 (0.7) for carbohydrates, 1.1 (0.3) and 1.5 (0.3) for protein, and 0.8 (0.3) and 1.4 (0.2) for fat. EA did not change across the four time points in either female (p = 0.30) or male (p = 0.05) athletes. The mean EA was lower in female athletes compared to male athletes (p = 0.03). Low EA (≤30 kcal/ kg fat-free mass/day) was observed in female (58 (29) % of days) and male (34 (23) % of days) athletes. Iron deficiency with anemia was observed in two female athletes. Mean vitamin D levels were insufficient (<75 nmol/L). Macronutrient intake, EA, and blood biochemical parameters were suboptimal in this cohort of elite wheelchair athletes, especially in female athletes.
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Effect of Probiotic Bifidobacterium breve in Improving Cognitive Function and Preventing Brain Atrophy in Older Patients with Suspected Mild Cognitive Impairment: Results of a 24-Week Randomized, Double-Blind, Placebo-Controlled Trial.
Asaoka, D, Xiao, J, Takeda, T, Yanagisawa, N, Yamazaki, T, Matsubara, Y, Sugiyama, H, Endo, N, Higa, M, Kasanuki, K, et al
Journal of Alzheimer's disease : JAD. 2022;88(1):75-95
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Probiotics are “live microorganisms which when administered in adequate amounts, confer a health benefit on the host” as defined by the International Scientific Association for Probiotics and Prebiotics. The aim of this study was to assess the effect of the probiotic strain Bifidobacterium breve MCC1274 in enhancing cognition and preventing brain atrophy of older patients with mild cognitive impairment (MCI). This study is a double-blind, randomised placebo-controlled trial. Participants (n=130) were randomly assigned to one of the two groups: probiotic group or placebo group. Results show improvement of cognitive function on some subscales scores but not the total scores by the consumption of B. breve MCC1274 in the MCI subjects. In addition, the probiotic supplementation for 24 weeks suppressed brain atrophy progression based on brain MRI. Authors conclude that B. breve MCC1274 is a practical approach for preventing cognitive impairment of MCI subjects. However, further research is necessary to understand B. breve MCC1274 mechanism(s) of action.
Abstract
BACKGROUND Probiotics have been reported to ameliorate cognitive impairment. OBJECTIVE We investigated the effect of the probiotic strain Bifidobacterium breve MCC1274 (A1) in enhancing cognition and preventing brain atrophy of older patients with mild cognitive impairment (MCI). METHODS In this RCT, 130 patients aged from 65 to 88 years old with suspected MCI received once daily either probiotic (B. breve MCC1274, 2×1010 CFU) or placebo for 24 weeks. Cognitive functions were assessed by ADAS-Jcog and MMSE tests. Participants underwent MRI to determine brain atrophy changes using Voxel-based Specific Regional Analysis System for Alzheimer's disease (VSRAD). Fecal samples were collected for the analysis of gut microbiota composition. RESULTS Analysis was performed on 115 participants as the full analysis set (probiotic 55, placebo 60). ADAS-Jcog subscale "orientation" was significantly improved compared to placebo at 24 weeks. MMSE subscales "orientation in time" and "writing" were significantly improved compared to placebo in the lower baseline MMSE (< 25) subgroup at 24 weeks. VSRAD scores worsened in the placebo group; probiotic supplementation tended to suppress the progression, in particular among those subjects with progressed brain atrophy (VOI Z-score ≥1.0). There were no marked changes in the overall composition of the gut microbiota by the probiotic supplementation. CONCLUSION Improvement of cognitive function was observed on some subscales scores only likely due to the lower sensitiveness of these tests for MCI subjects. Probiotics consumption for 24 weeks suppressed brain atrophy progression, suggesting that B. breve MCC1274 helps prevent cognitive impairment of MCI subjects.
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Probiotic Mixture Containing Lactobacillus helveticus, Bifidobacterium longum and Lactiplantibacillus plantarum Affects Brain Responses to an Arithmetic Stress Task in Healthy Subjects: A Randomised Clinical Trial and Proof-of-Concept Study.
Edebol Carlman, HMT, Rode, J, König, J, Repsilber, D, Hutchinson, AN, Thunberg, P, Persson, J, Kiselev, A, Pruessner, JC, Brummer, RJ
Nutrients. 2022;14(7)
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Physiological and psychological stress can affect gut function and its interaction with the brain (gut-brain axis). Different types of stress and different phases of stress regulation can affect the brain in different ways. Manipulation of the gut microbiota using probiotic bacteria has been shown to improve cognition and stress response. However, probiotic interventions are likely to have different effects depending on the strains used. The aim of this study was to assess the effects of a probiotic intervention on brain activity and stress response. This study is a randomised double-blinded placebo-controlled crossover study with 22 healthy subjects. Subjects were randomised to two study groups receiving the intervention in different orders (probiotics or placebo first). Results demonstrate that the probiotic intervention: - altered activity in specific brain regions known to regulate emotion and stress response. - significantly altered functional connectivity between the upper limbic and medioventral regions. - did not affect the activation of other limbic or subcortical areas. Authors conclude that their findings could further lead to possible clinical implications for improving stress resilience and potential roles in the treatment of affective and gut-brain axis disorders.
Abstract
Probiotics are suggested to impact physiological and psychological stress responses by acting on the gut-brain axis. We investigated if a probiotic product containing Bifidobacterium longum R0175, Lactobacillus helveticus R0052 and Lactiplantibacillus plantarum R1012 affected stress processing in a double-blinded, randomised, placebo-controlled, crossover proof-of-concept study (NCT03615651). Twenty-two healthy subjects (24.2 ± 3.4 years, 6 men/16 women) underwent a probiotic and placebo intervention for 4 weeks each, separated by a 4-week washout period. Subjects were examined by functional magnetic resonance imaging while performing the Montreal Imaging Stress Task (MIST) as well as an autonomic nervous system function assessment during the Stroop task. Reduced activation in regions of the lateral orbital and ventral cingulate gyri was observed after probiotic intervention compared to placebo. Significantly increased functional connectivity was found between the upper limbic region and medioventral area. Interestingly, probiotic intervention seemed to predominantly affect the initial stress response. Salivary cortisol secretion during the task was not altered. Probiotic intervention did not affect cognitive performance and autonomic nervous system function during Stroop. The probiotic intervention was able to subtly alter brain activity and functional connectivity in regions known to regulate emotion and stress responses. These findings support the potential of probiotics as a non-pharmaceutical treatment modality for stress-related disorders.
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Clinical, gut microbial and neural effects of a probiotic add-on therapy in depressed patients: a randomized controlled trial.
Schaub, AC, Schneider, E, Vazquez-Castellanos, JF, Schweinfurth, N, Kettelhack, C, Doll, JPK, Yamanbaeva, G, Mählmann, L, Brand, S, Beglinger, C, et al
Translational psychiatry. 2022;12(1):227
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Major depressive disorder (MDD) is one of the most prevalent and burdensome psychiatric disorders. Compelling preclinical data indicate that the gut microbiota affects brain functions and depressive behaviour, providing a promising novel target for the treatment of depression. The aims of this study were to (i) examine the effect of a short-term, high-dose probiotic add-on therapy on depressive symptoms in MDD patients, and (ii) explore the effects of a probiotic supplementation on gut microbiota composition as well as brain structure and function. This study was a double-blind randomised controlled trial of a probiotic add-on therapy for four weeks in depressed patients. Patients (n=60) were randomly allocated to the two study groups and tested at three different time points. Results showed that an add-on probiotic treatment improves depressive symptoms and maintains healthy enterotypes, species richness and increases specific health related bacterial taxa. Furthermore, on a neural level, probiotics altered negative biases and emotional valence additionally to treatment-as-usual for depression. Authors conclude that their findings highlight the role of the microbiota-gut-brain axis in MDD and emphasises the potential of microbiota-related treatment approaches as therapies to improve the effectiveness of current treatments in depression.
Abstract
A promising new treatment approach for major depressive disorder (MDD) targets the microbiota-gut-brain (MGB) axis, which is linked to physiological and behavioral functions affected in MDD. This is the first randomized controlled trial to determine whether short-term, high-dose probiotic supplementation reduces depressive symptoms along with gut microbial and neural changes in depressed patients. Patients with current depressive episodes took either a multi-strain probiotic supplement or placebo over 31 days additionally to treatment-as-usual. Assessments took place before, immediately after and again four weeks after the intervention. The Hamilton Depression Rating Sale (HAM-D) was assessed as primary outcome. Quantitative microbiome profiling and neuroimaging was used to detect changes along the MGB axis. In the sample that completed the intervention (probiotics N = 21, placebo N = 26), HAM-D scores decreased over time and interactions between time and group indicated a stronger decrease in the probiotics relative to the placebo group. Probiotics maintained microbial diversity and increased the abundance of the genus Lactobacillus, indicating the effectivity of the probiotics to increase specific taxa. The increase of the Lactobacillus was associated with decreased depressive symptoms in the probiotics group. Finally, putamen activation in response to neutral faces was significantly decreased after the probiotic intervention. Our data imply that an add-on probiotic treatment ameliorates depressive symptoms (HAM-D) along with changes in the gut microbiota and brain, which highlights the role of the MGB axis in MDD and emphasizes the potential of microbiota-related treatment approaches as accessible, pragmatic, and non-stigmatizing therapies in MDD. Trial Registration: www.clinicaltrials.gov , identifier: NCT02957591.
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One-year supplementation with Lactobacillus reuteri ATCC PTA 6475 counteracts a degradation of gut microbiota in older women with low bone mineral density.
Li, P, Ji, B, Luo, H, Sundh, D, Lorentzon, M, Nielsen, J
NPJ biofilms and microbiomes. 2022;8(1):84
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Osteoporosis is a highly prevalent bone disease in the elderly population and is characterised by decreased bone mineral density, deteriorated bone microarchitecture, reduced bone strength and increased susceptibility to fragility fractures. Due to the lack of awareness about osteoporosis, there is the need to develop a novel and effective intervention for its prevention and treatment. The aim of this study was to gain mechanistic insight into the effect of Lactobacillus reuteri ATCC PTA 6475 on bone metabolism and identify factors important for a good response to the probiotic. This study was based on a placebo-controlled cohort trial where 68 elderly women had been randomised to supplementation with the probiotic strain L. reuteri ATCC PTA 6475 or placebo. For this secondary analysis, 20 out of the 68 elderly women with bone loss who supplemented with probiotic L. reuteri ATCC PTA 6475 were selected. Results showed that after one-year probiotic supplementation, there was decreased inflammation and significantly increased gene richness of the gut microbiota in the good responders, whereas there was altered microbial composition and function, including enrichment of E. coli and its biofilm formation in the poor responders. Authors conclude that L. reuteri ATCC PTA 6475 supplementation might promote bone formation by modulating the gut microbiota composition and function, which could be crucial for the development of novel osteoporosis treatments.
Abstract
Recent studies have shown that probiotic supplementation has beneficial effects on bone metabolism. In a randomized controlled trial (RCT) we demonstrated that supplementation of Lactobacillus reuteri ATCC PTA 6475 reduced bone loss in older women with low bone mineral density. To investigate the mechanisms underlying the effect of L. reuteri ATCC PTA 6475 on bone metabolism, 20 women with the highest changes (good responders) and the lowest changes (poor responders) in tibia total volumetric BMD after one-year supplementation were selected from our previous RCT. In the current study we characterized the gut microbiome composition and function as well as serum metabolome in good responders and poor responders to the probiotic treatment as a secondary analysis. Although there were no significant differences in the microbial composition at high taxonomic levels, gene richness of the gut microbiota was significantly higher (P < 0.01 by the Wilcoxon rank-sum test) and inflammatory state was improved (P < 0.05 by the Wilcoxon signed-rank test) in the good responders at the end of the 12-month daily supplementation. Moreover, detrimental changes including the enrichment of E. coli (adjusted P < 0.05 by DESeq2) and its biofilm formation (P < 0.05 by GSA) observed in the poor responders were alleviated in the good responders by the treatment. Our results indicate that L. reuteri ATCC PTA 6475 supplementation has the potential to prevent a deterioration of the gut microbiota and inflammatory status in elderly women with low bone mineral density, which might have beneficial effects on bone metabolism.
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Probiotics-Supplemented Low-Protein Diet for Microbiota Modulation in Patients with Advanced Chronic Kidney Disease (ProLowCKD): Results from a Placebo-Controlled Randomized Trial.
De Mauri, A, Carrera, D, Bagnati, M, Rolla, R, Vidali, M, Chiarinotti, D, Pane, M, Amoruso, A, Del Piano, M
Nutrients. 2022;14(8)
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Chronic kidney disease (CKD) is characterized by the accumulation of a number of metabolites—referred to as uremic toxins—that cannot be excreted by failing kidneys. Dysbiotic microbiota is a feature of patients affected by CKD. The aim of this study was to evaluate whether the association of selected probiotics on top of a low protein diet (LPD) are able to reduce the burden of uremic, microbiota-derived, and proatherogenic toxins in patients with advanced renal failure who were not on dialysis. This study was a single-centre, double-blind, placebo-controlled, randomised study. Participants were prescribed LPD in addition to their ongoing pharmacological therapy; after 2 months (T2), they were randomized in a 1:1 ratio to receive, in addition to the LPD, either probiotics (probiotics group) or a placebo (placebo group). Results showed that a probiotics-supplemented LPD reduced traditional uremic, microbiota-derived and atherogenic uremic toxins, delayed the progression to end stage renal disease, allowed the reduction of loop diuretics and antihypertensive agent use, and improved quality of life. Authors conclude that a probiotics-supplemented LPD represents not only a holistic kidney-friendly approach but allows for ecological and planet-friendly management of renal disease.
Abstract
The probiotics-supplemented low-protein diet in chronic kidney disease (ProLowCKD) was a single-centre, double-blind, placebo-controlled, randomised trial that was conducted to investigate whether the association between a low protein diet (LPD) and a new formulation of probiotics (Bifidobacterium longum and Lactobacillus reuteri) was effective at reducing traditional uremic, microbiota-derived, and proatherogenic toxins in sixty patients affected by advanced CKD. After 2 months of a LPD-a reduction in blood urea nitrogen (52 ± 17 vs. 46 ± 15 mg/dL, p = 0.003), total cholesterol (185 ± 41 vs. 171 ± 34 mg/dL, p = 0.001), and triglycerides (194 ± 148 vs. 161 ± 70 mg/dL, p = 0.03) was observed; 57 subjects were then randomized to receive probiotics or a placebo for the subsequent 3 months. A total of 27 patients in the placebo group showed increased serum values of total cholesterol (169 ± 36 vs. 185 ± 40 mg/dL, p = 0.01), LDL cholesterol (169 ± 36 vs. 185 ± 40 mg/dL, p = 0.02), lipoprotein-associated phospholipase A2 (155.4 ± 39.3 vs. 167.5 ± 51.4 nmol/mL/min, p = 0.006), and indoxyl-sulphate (30.1 ± 17.6 vs. 34.5 ± 20.2 μM, p = 0.026), while the 24 subjects in the probiotics group showed a trend in the reduction of microbiota toxins. A reduction of antihypertensive and diuretic medications was possible in the probiotics group. This study shows that associating probiotics to LPD may have an additional beneficial effect on the control and modulation of microbiota-derived and proatherogenic toxins in CKD patients.
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Increased Colonic Permeability and Lifestyles as Contributing Factors to Obesity and Liver Steatosis.
Di Palo, DM, Garruti, G, Di Ciaula, A, Molina-Molina, E, Shanmugam, H, De Angelis, M, Portincasa, P
Nutrients. 2020;12(2)
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Intestinal permeability (IP) is dependent on the structure and function of the intestinal barrier. The gut barrier integrity is the result of ongoing equilibrium and crosstalk involving the microbiome, the mucus, the enterocytes [intestinal absorptive cells], the gut immune system, and the gut–vascular barrier. The main aim of this study was to explore the pan-enteric IP (stomach, small intestine, and colon) with respect to size and fat distribution, as well as the presence of liver steatosis. The study is a cohort study that examined 120 subjects (obese n = 45, overweight n=30, normal weight n = 45). Groups were gender-matched except for the prevalence of males in the overweight group. Results highlight the existence of an association between colonic (but not stomach and small intestinal) permeability, obesity, and liver steatosis. Findings show that: - liver steatosis was detected in 69 (57.5%) subjects, of which 36 (52%) were males. The prevalence of liver steatosis increased from 4% in normal weight subjects to 77%, and to 98% in overweight and obese subjects, respectively. - gastrointestinal permeability changed between age groups at every tract, whereas stomach and small intestine IP decreased with age. Furthermore, this finding also occurred in subjects aged over or equal to 65 years, with respect to colonic permeability. Authors conclude that further studies must evaluate the possibility of modulating colonic permeability to allow both primary prevention measures and new therapeutic strategies in metabolic and liver diseases.
Abstract
Intestinal permeability (IP) is essential in maintaining gut-metabolic functions in health. An unequivocal evaluation of IP, as marker of intestinal barrier integrity, however, is missing in health and in several diseases. We aimed to assess IP in the whole gastrointestinal tract according to body mass index (BMI) and liver steatosis. In 120 patients (61F:59M; mean age 45 ± SEM 1.2 years, range: 18-75), IP was distinctively studied by urine recovery of orally administered sucrose (SO, stomach), lactulose/mannitol ratio (LA/MA, small intestine), and sucralose (SA, colon). By triple quadrupole mass-spectrometry and high-performance liquid chromatography, we measured urinary recovery of saccharide probes. Subjects were stratified according to BMI as normal weight, overweight, and obesity, and answered questionnaires regarding dietary habits and adherence to the Mediterranean Diet. Liver steatosis was assessed by ultrasonography. IP at every gastrointestinal tract was similar in both sexes and decreased with age. Stomach and small intestinal permeability did not differ according to BMI. Colonic permeability increased with BMI, waist, neck, and hip circumferences and was significantly higher in obese than in lean subjects. As determined by logistic regression, the odds ratio (OR) of BMI increment was significantly higher in subjects in the highest tertile of sucralose excretion, also after adjusting for age and consumption of junk food. The presence of liver steatosis was associated with increased colonic permeability. Patients with lower score of adherence to Mediterranean diet had a higher score of 'junk food'. Intestinal permeability tended to increase in subjects with a lower adherence to Mediterranean diet. In conclusion, colonic (but not stomach and small intestinal) permeability seems to be linked to obesity and liver steatosis independently from dietary habits, age, and physical activity. The exact role of these last factors, however, requires specific studies focusing on intestinal permeability. Results should pave the way to both primary prevention measures and new therapeutic strategies in metabolic and liver diseases.
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Daily Intake of Fermented Milk Containing Lactobacillus casei Shirota (Lcs) Modulates Systemic and Upper Airways Immune/Inflammatory Responses in Marathon Runners.
Vaisberg, M, Paixão, V, Almeida, EB, Santos, JMB, Foster, R, Rossi, M, Pithon-Curi, TC, Gorjão, R, Momesso, CM, Andrade, MS, et al
Nutrients. 2019;11(7)
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Athletes undergoing high-intensity efforts show increased incidence of upper respiratory tract infections (URTI), both in the context of competitions and during strenuous training. The aim of this study was to evaluate the influence of the daily intake of fermented milk (containing Lactobacillus casei Shirota) on the systemic and upper airway immune/inflammatory responses before and after a race in marathon runners who previously reported upper respiratory symptoms (URS) after an exhaustive physical exercise session. The study is a double-blind randomised clinical study which recruited 42 male amateur marathon runners with an average age of 39 years. The participants were randomly separated into two groups: Lactobacillus casei Shirota group (n=20) or the placebo group (n=22). Results indicate that daily ingestion of fermented milk (containing Lactobacillus casei Shirota) was able to control both immunological and inflammatory responses in the blood and also in the upper airways mucosal of amateurs´ runners after a marathon. Authors conclude that Lactobacillus casei Shirota is able to modulate the systemic and airways immune responses post-marathon, presenting protective effects.
Abstract
BACKGROUND Although Lactobacillus casei Shirota (LcS) can benefit the immune status, the effects of LcS in the immune/inflammatory responses of marathon runners has never been evaluated. Therefore, here we evaluated the effect of daily ingestion of fermented milk containing or not LcS in the systemic and upper airway immune/inflammatory responses before and after a marathon. METHODS Forty-two male marathon runners ingested a fermented milk containing 40 billion of LcS/day (LcS group, n = 20) or placebo (unfermented milk, n = 22) during 30 days pre-marathon. Immune/inflammatory parameters in nasal mucosa and serum, as well as concentrations of secretory IgA (SIgA) and antimicrobial peptides in saliva, were evaluated before and after fermented milk ingestion, immediately, 72 h, and 14 d post-marathon. RESULTS Higher proinflammatory cytokine levels in serum and nasal mucosa, and also lower salivary levels of SIgA and antimicrobial peptides, were found immediately post-marathon in the placebo group compared to other time points and to LcS group. In opposite, higher anti-inflammatory levels and reduced neutrophil infiltration on nasal mucosa were found in the LcS group compared to other time points and to the placebo group. CONCLUSION For the first time, it is shown that LcS is able to modulate the systemic and airways immune responses post-marathon.
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Combined bioavailable isoflavones and probiotics improve bone status and estrogen metabolism in postmenopausal osteopenic women: a randomized controlled trial.
Lambert, MNT, Thybo, CB, Lykkeboe, S, Rasmussen, LM, Frette, X, Christensen, LP, Jeppesen, PB
The American journal of clinical nutrition. 2017;106(3):909-920
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Oestrogens play a vital role in maintaining bone health. The natural decline in oestrogen during menopause negatively impacts bone mineral density and increases the risk of osteoporosis and fractures. Standard interventions offered include calcium and vitamin D supplementation and hormone replacement therapy. As hormone replacement therapy is associated with increased cancer risk, there is a need to find effective treatments that display a suitable safety profile for long-term use. Isoflavones are compounds found in legume plants, many of which are dietary staples in some cultures. Isoflavones are phytoestrogens, substances that can selectively interact with human oestrogen receptors. Initial research on Isoflavones indicated that it reduces bone breakdown whilst showing protective effects for certain cancers. This randomized, double- blind, placebo-controlled trial compared the effectiveness of an lactic acid fermented, probiotic-rich isoflavone product from Red Clover (RCE) or a placebo, when given in addition to Calcium, Magnesium and Vitamin D (CMD) in postmenopausal women with osteopenia. Participants were monitored using blood tests assessing phytoestrogen activity and oestrogen metabolism, DXA scans to observe changes in bone structure and activity and dietary questionnaires. A total of 78 participants completed the study. The results showed that twice a day 60 mg isoflavones from RCE had a significant physiological impact on preventing bone loss associated with oestrogen deficiency, and was more effective in preserving bone density than CDM alone. The authors concluded that RCE was close to effectiveness to conventional bone-preserving treatments like hormone therapy but stood out due to its better safety profile and minimal side effects. Gut bacteria enhance the effectiveness of these isoflavones, which can be metabolised into compounds called equol. While before the study none of the participants could produce equol, in the end, half of the participants in the RCE group were able to produce equol, suggesting that the probiotic presence in the supplement positively influenced the participants' gut bacteria, creating favourable conditions. Additionally, RCE treatment led to favourable changes in urinary oestrogen metabolites associated with less carcinogenic oestrogen metabolism. In conclusion, the probiotic RCE, enhanced the effectiveness of CMD in preventing bone loss, whilst also increasing the ability to produce equol.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Fermented red clover extract, rich in bioavailable isoflavones with selective oestrogen receptor affinity and probiotics, combined with traditional supplementation (calcium, magnesium and vitamin D) improves bone mineral density and bone turnover compared to placebo in post menopausal women with osteopenia.
- Combining probiotics with isoflavones appears to enhance intestinal isoflavone uptake and isoflavone metabolism.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
This was a well-constructed randomised, parallel-design, placebo-controlled, double-blind trial over 12 months. The primary aim was to determine the effectiveness of a novel fermented red clover extract (RCE) containing isoflavones and probiotics combined with traditional calcium/magnesium/vitamin D supplementation, in comparison with traditional calcium/magnesium/vitamin D supplementation alone on bone mineral density (BMD) in postmenopausal women with osteopenia.
Methods
- The trial followed the guidelines of the Declaration of Helsinki and received ethics approval.
- Inclusion criteria: female; >=1 year postmenopause; age 60-85; and bone T score of -1 to -2.25.
- Exclusion criteria: medical treatment for osteopenia or hormone replacement therapy within the past 3 months; diet rich in or supplementation with isoflavones; supplementation with Vitamin K; medical history of stipulated conditions.
- 85 participants were eligible and randomised to either the control or treatment group.
- Treatment group received 95 mL of RCE twice daily, containing 60 mg isoflavone aglycones and probiotics, plus 1040mg calcium, 487mg magnesium and 25μg Vitamin D daily (CMD/d). Control group received masked RCE placebo plus CMD/d.
Results
- The change in BMD (p=0.043) and T score (p=0.045) showed a statistically significant greater decrease in the lumbar spine, femoral neck and hip of the control group than the RCE treatment group after 12 months of treatment.
- A statistically significant reduction in one bone resorption marker was found in the RCE group compared to control (p=0.045). All other bone biomarkers failed to reach significance.
- Plasma isoflavone concentration was elevated in the RCE treatment group compared to control (p=0.0094).
- The concentration ratios of urinary oestrogen metabolites 2-OH:16αOH was significantly increased in the RCE group compared to control (p=0.026).
Conclusion
Fermented RCE with CMD/d slowed oestrogen-deficient BMD loss and improved one marker of bone turnover in postmenopausal osteopenic women. Combining RCE with CMD/d was found to be more effective in preserving bone density than CMD/d alone in this target group. Probiotics in the fermented RCE appear to enhance intestinal isoflavone uptake, metabolism, and therapeutic effect.
Clinical practice applications:
- Healthcare practitioners working with women in post-menopause with osteopenia could consider the addition of fermented RCE with CMD/d for improved bone mineral density and bone turnover over 12 months.
- Given the positive impact of RCE intake over 12 months on 2-OH:16αOH oestrogen metabolite ratios, healthcare practitioners could consider fermented RCE when HRT is not an available option in relation to cancer risk.
- Based on these results, Nutritional Therapists working with post-menopausal women with osteopenia can focus on dietary isoflavone intake and pre and probiotic foods to support BMD, alongside supplementary options.
Considerations for future research:
- Given the length of time taken in bone remodelling cycles, a clinical trial of more than 2 years would strengthen the evidence provided by DXA scan.
- All trial participants were normotensive and healthy weight. Future studies could include women with hypertension and obesity to determine effects of RCE on bone and blood pressure/lipid markers in this group.
- Controlled feeding studies to determine the dietary effects of isoflavones and pre and probiotic foods would provide additional information in this area.
- Other fermented RCE products should be trialled to replicate findings.
Abstract
Background: Female age-related estrogen deficiency increases the risk of osteoporosis, which can be effectively treated with the use of hormone replacement therapy. However, hormone replacement therapy is demonstrated to increase cancer risk. Bioavailable isoflavones with selective estrogen receptor affinity show potential to prevent and treat osteoporosis while minimizing or eliminating carcinogenic side effects.Objective: In this study, we sought to determine the beneficial effects of a bioavailable isoflavone and probiotic treatment against postmenopausal osteopenia.Design: We used a novel red clover extract (RCE) rich in isoflavone aglycones and probiotics to concomitantly promote uptake and a favorable intestinal bacterial profile to enhance isoflavone bioavailability. This was a 12-mo, double-blind, parallel design, placebo-controlled, randomized controlled trial of 78 postmenopausal osteopenic women supplemented with calcium (1200 mg/d), magnesium (550 mg/d), and calcitriol (25 μg/d) given either RCE (60 mg isoflavone aglycones/d and probiotics) or a masked placebo [control (CON)].Results: RCE significantly attenuated bone mineral density (BMD) loss at the L2-L4 lumbar spine vertebra (P < 0.05), femoral neck (P < 0.01), and trochanter (P < 0.01) compared with CON (-0.99% and -2.2%; -1.04% and -3.05%; and -0.67% and -2.79, respectively). Plasma concentrations of collagen type 1 cross-linked C-telopeptide was significantly decreased in the RCE group (P < 0.05) compared with CON (-9.40% and -6.76%, respectively). RCE significantly elevated the plasma isoflavone concentration (P < 0.05), the urinary 2-hydroxyestrone (2-OH) to 16α-hydroxyestrone (16α-OH) ratio (P < 0.05), and equol-producer status (P < 0.05) compared with CON. RCE had no significant effect on other bone turnover biomarkers. Self-reported diet and physical activity were consistent and differences were nonsignificant between groups throughout the study. RCE was well tolerated with no adverse events.Conclusions: Twice daily RCE intake over 1 y potently attenuated BMD loss caused by estrogen deficiency, improved bone turnover, promoted a favorable estrogen metabolite profile (2-OH:16α-OH), and stimulated equol production in postmenopausal women with osteopenia. RCE intake combined with supplementation (calcium, magnesium, and calcitriol) was more effective than supplementation alone. This trial was registered at clinicaltrials.gov as NCT02174666.